{
    "info": {
        "nct_id": "NCT04856631",
        "official_title": "A Phase Ib/II, Single-arm, Multi-center Clinical Study of Toripalimab Injection (JS001) + Cetuximab in Treatment of Advanced Head and Neck Squamous Cell Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria： 1. Patients voluntarily participate in this study after full informed consent and sign a written informed consent form; 2. Age >=18 to <=75 years at time of consenting; 3. Relapsed or metastatic head and neck squamous cell cancer confirmed histologically or cytologically, and occurred in mouth, oropharynx, laryngopharynx, throat, or paranasal sinus, already being unsuitable to receive local therapy such as surgery or radiotherapy; 4. Phase Ib and Phase II Cohort A:Previously receiving a first-line platinum-based chemotherapy against relapsed or metastatic disease, and developing progressive disease during or after treatment; or receiving platinum-based chemotherapy as neoadjuvant or adjuvant chemotherapy (or chemoradiotherapy), and developing relapse or metastasis within 6 months after end of treatment.\n\n5.Phase II cohort B:\n\n1. No previous systemic treatment for relapsed or metastatic disease. Relapse or metastasis more than 6 months after the end of treatment if previously treated with systemic therapy as part of local treatment.\n2. Qualified tumor tissue samples with positive PD-L1 expression (defined as Combined Positive Score (CPS) ≥ 1) tested by the central laboratory are required.\n\n6. All acute toxic reactions from prior antitumor therapy, surgical procedures, or radiotherapy, etc., are relieved to Grades 0-1 (in accordance with NCI-CTCAE version 5.0) or to the level specified in the inclusion/exclusion criteria. Hair loss or pigmentation, or other toxicities that would not result in safety risk to subjects and would not influence compliance, as considered by the investigator, Are ruled out.\n\n7. Previous tumor samples or fresh tumor tissue biopsy samples may be provided.\n\n8 For subjects with oropharyngeal cancer, a prior test report for HPV16 may be provided, or eligible tumor tissue samples are provided to test HPV status.\n\n9. At least one measurable lesion in accordance with RECIST 1.1 assessment criteria;\n\n10 Patients with life expectancy >=12 weeks;\n\n11. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 point;\n\n12. Good organ function level:\n\nSystem organ Lab Value\n\nHematology (no blood transfusion or colony-stimulating factor or other drug correction within 14 days prior to the first study dose)\n\nNeutrophil count ≥1.5×10^9/L\n\nPlatelet count ≥100×10^9/L\n\nHemoglobin ≥90 g/L\n\nKidney function\n\nSerum creatinine <=1.5 x upper limit of normal (ULN) or Creatinine clearance is calculated with reference to the Cockcroft-Gault formula or the site practices ≥50 mL/min\n\nHepatic function\n\ntotal Bilirubin <=1.5 x ULN or<=3 x ULN (patients with known Gilbert's disease)\n\nALT/AST <=3 x ULN (without liver metastasis) or<=5 x ULN (in case of liver metastases)\n\nAlbumin (no infusion of albumin product with 14 days prior to the first dose of the investigational medical product)≥30g/L\n\nCoagulation function\n\nInternational normalized ratio (INR)\n\nProthrombin Time (PT)\n\nActivated Partial Thromboplastin Time (aPTT) <=1.5 x ULN\n\n13. Within 72 h prior to the first dose, for women of childbearing age must confirm that the serum pregnancy test is negative and agree to adopt effective contraceptive measures during use of the investigational medical product and for 5 months after last dose. A female of childbearing potential in this Protocol is defined as a sexually mature female who:\n\n1) No hysterectomy or bilateral oophorectomy, 2) Spontaneous menopause does not last for 24 consecutive months (amenorrhea after cancer treatment does not rule out fertility) (i.e., menstruation at any time within the previous 24 consecutive months).\n\nMale patients with partners of childbearing potential must agree to use effective contraception during the use of the investigational medical product and for 5 months after last dose.\n\nExclusion criteria：\n\n1. Nasopharyngeal cancer or salivary gland cancer confirmed histologically or cytologically, or other non-squamous cell cancer (e.g., adenocarcinoma, sarcoma, or mixed cancer), or metastatic squamous cell cancer with unknown primary site.\n2. Patients with necrotic lesion, at risk for major hemorrhage as judged by the investigator.\n3. Previously receiving other immune checkpoint inhibitors/drugs acting on immune checkpoint pathway/other drugs acting on T cell costimulation (e.g.: PD-1/PD-L1 antibody or CTLA-4 antibody);\n4. Previous treatment of EGFR inhibitor (including radiotherapy sensitization therapy);\n5. Diagnosed with other malignancies within 5 years prior to study entry, except for basal cell carcinoma of the skin or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or carcinoma in situ of the breast that can be cured by local therapy\n6. Existing uncontrollable or symptomatic active central nervous system (CNS) metastasis, that may be characterized by clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, pia mater disease, and/or progressive growth;\n\n1) Patients with asymptomatic spinal cord compression indicated radiologically may be enrolled, if assessed as stable by the specialist and requiring no treatment presently; 2) Patients who have previously received treatment for CNS metastases, and become stable for >=4 weeks as indicated radiologically in the screening period, and stopped systemic hormone therapy (prednisone in a dose >10 mg/d or an equivalent hormone) for >=4 weeks prior to the first dose of the investigational therapy may be enrolled;\n\n7. Poorly controlled hydrothorax, hydrops abdominis, or pericardial effusion;\n\n8. Existing Grade >=2 (in accordance with NCI-CTCAE 5.0) peripheral neuropathy or hearing loss;\n\n9. Pregnant or breastfeeding female subjects;\n\n10. In the following cases within 6 months prior to the first dose: Myocardial infarction, serious/unstable angina, NYHA Grade >=2 cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, or symptomatic congestive heart failure;\n\nNote: Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction < 50% must be treated with an optimized stable medical regimen at the discretion of the treating physician, with consultation with a cardiologist, as appropriate;\n\n11. Poorly controlled hypertension (systolic blood pressure (BP) >=160 mmHg and/or diastolic blood pressure >=100 mmHg) (based on the mean of >=3 BP readings obtained from >=2 measurements); hypertensive crisis or hypertensive encephalopathy within 6 months prior to the first dose.\n\n12. Patients with known allergy to the investigational medical product or any excipient, or with serious allergic reaction to other monoclonal antibodies;\n\n13. Receiving the following drugs or therapies prior to first dose of investigational medical product :\n\n1. Major surgery within 28 d prior to the first dose of the investigational therapy (tissue biopsy required for diagnosis, and pieripherally inserted central catheter [PICC] or infusion port implantation are permissible).\n2. Antitumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, cytokine therapy, or biological therapy, etc.) with 28 d prior to the first dose of the investigational medical product;\n3. Participation in other intervention studies within 28 d prior to the first dose of the investigational medical product;\n4. Treatment with a systemic immunostimulatory drug (including but not limited to interferon or IL-2) within 14 d or 5 half-lives of the investigational medicinal product (whichever is longer) prior to the first dose of the investigational medical product;\n5. Treatment of a systemic corticosteroid (> 10 mg/d prednisone or equivalent drug) or other systemic immunosuppressive drugs (including but not limited to Cyclophosphamide, Azathioprine, Methotrexate, Thalidomide and anti-tumor necrosis factor drugs [anti-TNF]) within 14 d prior to the first dose of the investigational therapy;\n\n   o Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are permitted;\n   * Patients receiving an acute low-dose systemic immunosuppressive agent (e.g., a single dose of dexamethasone for nausea, or preventive medication prior to administration of Cetuximab ) may be enrolled after discussion with and approval by the medical monitor;\n   * Patients who need baseline and follow-up MRI/CT tumor assessment can use steroids prophylaxis if they have previous allergic reactions to intravenous contrast media.\n   * Inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension, and low-dose corticosteroids for maintenance treatment of adrenocortical insufficiency are permitted;\n6. Treatment of oral or intravenous antibiotic therapy (except preventive use of antibiotics) with 14 d prior to the first dose of the investigational therapy;\n7. Vaccination of any live vaccine (e.g., vaccine against infectious diseases, such as influenza vaccine or varicella vaccine, etc.) within 28 d prior to the first dose of the investigational medical product;\n\n14. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-related vascular thrombosis, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, glomerulonephritis;\n\n1. Patients with autoimmune-related hypothyroidism on a stable dose of thyroid hormone replacement are eligible;\n2. Patients with type 1 diabetes who are controlled after receiving a stable insulin regimen are eligible for this study;\n\n15. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n\n16. Serious infection (NCI-CTCAE Grade >2) within 28 d prior to the first dose of the investigational therapy, e.g., serious pneumonia requiring hospitalization, bacteremia, or infection complications, etc.\n\n17. Active infection, including but not limited to tuberculosis (clinical diagnosis including clinical history, physical examination and imaging findings, and TB screening according to local medical routine), hepatitis B, hepatitis C or human immunodeficiency virus (HIV antibody positive);\n\n1. Patients who are positive for hepatitis B surface antigen (HBsAg+) and/or hepatitis B core antibody (HBcAb+) are required to undergo hepatitis B virus deoxyribonucleic acid (HBV DNA) test. If HBV DNA copy number is ˂1000 cps/mL or <200 IU/mL, or less than the lower limit of detectable value at the study site, the patients are eligible to participate in this study;\n2. Patients who are positive for hepatitis C antibody (HCV Ab+) are required to have an HCV RNA test and are eligible for this study only if they are negative for HCV RNA (defined as below the lower limit of detectable value at the research site);\n\n18. Idiopathic pulmonary fibrosis, drug-induced pneumonia, organized pneumonia (i.e., bronchiolitis obliterans), clinically symptomatic radiation pneumonia or active pneumonia, or those requiring steroid therapy, or other moderate to severe pulmonary diseases influencing seriously pulmonary function.\n\n19. Patients with existing other serious physical or mental disorders or laboratory test abnormalities, or alcoholism or drug abuse, etc., that may increase the risk for participation in the study, influence compliance to the treatment, or interference the study results, or other conditions that are not suitable for participation in the study, as judged by the investigator"
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "Inclusion criteria： 1. Patients voluntarily participate in this study after full informed consent and sign a written informed consent form; 2. Age >=18 to <=75 years at time of consenting; 3. Relapsed or metastatic head and neck squamous cell cancer confirmed histologically or cytologically, and occurred in mouth, oropharynx, laryngopharynx, throat, or paranasal sinus, already being unsuitable to receive local therapy such as surgery or radiotherapy; 4. Phase Ib and Phase II Cohort A:Previously receiving a first-line platinum-based chemotherapy against relapsed or metastatic disease, and developing progressive disease during or after treatment; or receiving platinum-based chemotherapy as neoadjuvant or adjuvant chemotherapy (or chemoradiotherapy), and developing relapse or metastasis within 6 months after end of treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Patients voluntarily participate in this study after full informed consent and sign a written informed consent form",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Age >=18 to <=75 years at time of consenting",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Relapsed or metastatic head and neck squamous cell cancer confirmed histologically or cytologically",
                        "criterion": "head and neck squamous cell cancer",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "occurred in mouth, oropharynx, laryngopharynx, throat, or paranasal sinus",
                        "criterion": "cancer location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "mouth",
                                "oropharynx",
                                "laryngopharynx",
                                "throat",
                                "paranasal sinus"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "already being unsuitable to receive local therapy such as surgery or radiotherapy",
                        "criterion": "suitability for local therapy",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Phase Ib and Phase II Cohort A:Previously receiving a first-line platinum-based chemotherapy against relapsed or metastatic disease",
                        "criterion": "previous chemotherapy",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "first-line platinum-based chemotherapy"
                        }
                    },
                    {
                        "exact_snippets": "developing progressive disease during or after treatment",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "during or after treatment"
                        }
                    },
                    {
                        "exact_snippets": "receiving platinum-based chemotherapy as neoadjuvant or adjuvant chemotherapy (or chemoradiotherapy)",
                        "criterion": "previous chemotherapy",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "platinum-based chemotherapy as neoadjuvant or adjuvant"
                        }
                    },
                    {
                        "exact_snippets": "developing relapse or metastasis within 6 months after end of treatment",
                        "criterion": "relapse or metastasis timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 6 months after end of treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients voluntarily participate in this study after full informed consent and sign a written informed consent form",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Age >=18 to <=75 years at time of consenting",
                                "criterion": "age",
                                "requirement": {
                                    "requirement_type": "range",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 18,
                                                "unit": "years"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 75,
                                                "unit": "years"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Relapsed or metastatic head and neck squamous cell cancer confirmed histologically or cytologically",
                                "criterion": "head and neck squamous cell cancer",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": [
                                        "histologically",
                                        "cytologically"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "occurred in mouth, oropharynx, laryngopharynx, throat, or paranasal sinus",
                                "criterion": "cancer location",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": [
                                        "mouth",
                                        "oropharynx",
                                        "laryngopharynx",
                                        "throat",
                                        "paranasal sinus"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "already being unsuitable to receive local therapy such as surgery or radiotherapy",
                                "criterion": "suitability for local therapy",
                                "requirement": {
                                    "requirement_type": "suitability",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Phase Ib and Phase II Cohort A:Previously receiving a first-line platinum-based chemotherapy against relapsed or metastatic disease",
                                        "criterion": "previous chemotherapy",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "first-line platinum-based chemotherapy"
                                        }
                                    },
                                    {
                                        "exact_snippets": "developing progressive disease during or after treatment",
                                        "criterion": "disease progression",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": "during or after treatment"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "receiving platinum-based chemotherapy as neoadjuvant or adjuvant chemotherapy (or chemoradiotherapy)",
                                        "criterion": "previous chemotherapy",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "platinum-based chemotherapy as neoadjuvant or adjuvant"
                                        }
                                    },
                                    {
                                        "exact_snippets": "developing relapse or metastasis within 6 months after end of treatment",
                                        "criterion": "relapse or metastasis timing",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": "within 6 months after end of treatment"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5.Phase II cohort B:",
                "criterions": [
                    {
                        "exact_snippets": "Phase II cohort B",
                        "criterion": "trial phase",
                        "requirement": {
                            "requirement_type": "phase",
                            "expected_value": "II"
                        }
                    },
                    {
                        "exact_snippets": "Phase II cohort B",
                        "criterion": "trial phase",
                        "requirement": {
                            "requirement_type": "cohort",
                            "expected_value": "B"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Phase II cohort B",
                        "criterion": "trial phase",
                        "requirement": {
                            "requirement_type": "phase",
                            "expected_value": "II"
                        }
                    },
                    {
                        "exact_snippets": "Phase II cohort B",
                        "criterion": "trial phase",
                        "requirement": {
                            "requirement_type": "cohort",
                            "expected_value": "B"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. No previous systemic treatment for relapsed or metastatic disease. Relapse or metastasis more than 6 months after the end of treatment if previously treated with systemic therapy as part of local treatment.",
                "criterions": [
                    {
                        "exact_snippets": "No previous systemic treatment for relapsed or metastatic disease.",
                        "criterion": "previous systemic treatment for relapsed or metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Relapse or metastasis more than 6 months after the end of treatment if previously treated with systemic therapy as part of local treatment.",
                        "criterion": "relapse or metastasis timing",
                        "requirement": {
                            "requirement_type": "time since end of treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "No previous systemic treatment for relapsed or metastatic disease.",
                    "criterion": "previous systemic treatment for relapsed or metastatic disease",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "then_criteria": null,
                "else_criteria": {
                    "exact_snippets": "Relapse or metastasis more than 6 months after the end of treatment if previously treated with systemic therapy as part of local treatment.",
                    "criterion": "relapse or metastasis timing",
                    "requirement": {
                        "requirement_type": "time since end of treatment",
                        "expected_value": {
                            "operator": ">",
                            "value": 6,
                            "unit": "months"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Qualified tumor tissue samples with positive PD-L1 expression (defined as Combined Positive Score (CPS) ≥ 1) tested by the central laboratory are required.",
                "criterions": [
                    {
                        "exact_snippets": "Qualified tumor tissue samples",
                        "criterion": "tumor tissue samples",
                        "requirement": {
                            "requirement_type": "qualification",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive PD-L1 expression (defined as Combined Positive Score (CPS) ≥ 1)",
                        "criterion": "PD-L1 expression",
                        "requirement": {
                            "requirement_type": "expression level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "CPS"
                            }
                        }
                    },
                    {
                        "exact_snippets": "tested by the central laboratory",
                        "criterion": "testing location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "central laboratory"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Qualified tumor tissue samples",
                        "criterion": "tumor tissue samples",
                        "requirement": {
                            "requirement_type": "qualification",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive PD-L1 expression (defined as Combined Positive Score (CPS) ≥ 1)",
                        "criterion": "PD-L1 expression",
                        "requirement": {
                            "requirement_type": "expression level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "CPS"
                            }
                        }
                    },
                    {
                        "exact_snippets": "tested by the central laboratory",
                        "criterion": "testing location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "central laboratory"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. All acute toxic reactions from prior antitumor therapy, surgical procedures, or radiotherapy, etc., are relieved to Grades 0-1 (in accordance with NCI-CTCAE version 5.0) or to the level specified in the inclusion/exclusion criteria. Hair loss or pigmentation, or other toxicities that would not result in safety risk to subjects and would not influence compliance, as considered by the investigator, Are ruled out.",
                "criterions": [
                    {
                        "exact_snippets": "All acute toxic reactions from prior antitumor therapy, surgical procedures, or radiotherapy, etc., are relieved to Grades 0-1 (in accordance with NCI-CTCAE version 5.0)",
                        "criterion": "acute toxic reactions",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "Grade"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hair loss or pigmentation, or other toxicities that would not result in safety risk to subjects and would not influence compliance, as considered by the investigator, Are ruled out.",
                        "criterion": "toxicities that would not result in safety risk to subjects and would not influence compliance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "All acute toxic reactions from prior antitumor therapy, surgical procedures, or radiotherapy, etc., are relieved to Grades 0-1 (in accordance with NCI-CTCAE version 5.0)",
                                "criterion": "acute toxic reactions",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 1,
                                                "unit": "Grade"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Hair loss or pigmentation, or other toxicities that would not result in safety risk to subjects and would not influence compliance, as considered by the investigator, Are ruled out.",
                                "criterion": "toxicities that would not result in safety risk to subjects and would not influence compliance",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Previous tumor samples or fresh tumor tissue biopsy samples may be provided.",
                "criterions": [
                    {
                        "exact_snippets": "Previous tumor samples or fresh tumor tissue biopsy samples may be provided.",
                        "criterion": "tumor samples",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Previous tumor samples or fresh tumor tissue biopsy samples may be provided.",
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                            "expected_value": true
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8 For subjects with oropharyngeal cancer, a prior test report for HPV16 may be provided, or eligible tumor tissue samples are provided to test HPV status.",
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                    {
                        "exact_snippets": "subjects with oropharyngeal cancer",
                        "criterion": "oropharyngeal cancer",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior test report for HPV16 may be provided",
                        "criterion": "HPV16 test report",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "eligible tumor tissue samples are provided to test HPV status",
                        "criterion": "tumor tissue samples for HPV status",
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                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    }
                ]
            },
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                "condition": {
                    "exact_snippets": "subjects with oropharyngeal cancer",
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                },
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                        {
                            "exact_snippets": "prior test report for HPV16 may be provided",
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                                "requirement_type": "availability",
                                "expected_value": true
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                        },
                        {
                            "exact_snippets": "eligible tumor tissue samples are provided to test HPV status",
                            "criterion": "tumor tissue samples for HPV status",
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                                "requirement_type": "availability",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "9. At least one measurable lesion in accordance with RECIST 1.1 assessment criteria;",
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                    {
                        "exact_snippets": "At least one measurable lesion",
                        "criterion": "measurable lesion",
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                            "requirement_type": "quantity",
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                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "in accordance with RECIST 1.1 assessment criteria",
                        "criterion": "RECIST 1.1 assessment criteria",
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                            "requirement_type": "compliance",
                            "expected_value": true
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                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "At least one measurable lesion",
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                            "requirement_type": "quantity",
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                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "in accordance with RECIST 1.1 assessment criteria",
                        "criterion": "RECIST 1.1 assessment criteria",
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                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10 Patients with life expectancy >=12 weeks;",
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                    {
                        "exact_snippets": "life expectancy >=12 weeks",
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                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
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                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "life expectancy >=12 weeks",
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                                "operator": ">=",
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                                "unit": "weeks"
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 point;",
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                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 point",
                        "criterion": "ECOG performance status score",
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                            "requirement_type": "range",
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                                    {
                                        "operator": ">=",
                                        "value": 0,
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                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "point"
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                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 point",
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                            "requirement_type": "range",
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                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "point"
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                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "point"
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                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Good organ function level:",
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                    {
                        "exact_snippets": "Good organ function level",
                        "criterion": "organ function",
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                            "requirement_type": "level",
                            "expected_value": "good"
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                    }
                ]
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                    {
                        "exact_snippets": "Good organ function level",
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        },
        {
            "identified_line": {
                "line": "System organ Lab Value",
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                    {
                        "exact_snippets": "System organ",
                        "criterion": "system organ",
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                            "requirement_type": "N/A",
                            "expected_value": "Lab Value"
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                    {
                        "exact_snippets": "System organ",
                        "criterion": "system organ",
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                            "requirement_type": "N/A",
                            "expected_value": "Lab Value"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Neutrophil count ≥1.5×10^9/L",
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                    {
                        "exact_snippets": "Neutrophil count ≥1.5×10^9/L",
                        "criterion": "neutrophil count",
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                            "requirement_type": "quantity",
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                                "operator": ">=",
                                "value": 1.5,
                                "unit": "10^9/L"
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                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Neutrophil count ≥1.5×10^9/L",
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                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "10^9/L"
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            }
        },
        {
            "identified_line": {
                "line": "Platelet count ≥100×10^9/L",
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                    {
                        "exact_snippets": "Platelet count ≥100×10^9/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
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                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Platelet count ≥100×10^9/L",
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                            "requirement_type": "quantity",
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                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
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                ]
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        },
        {
            "identified_line": {
                "line": "Hemoglobin ≥90 g/L",
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                    {
                        "exact_snippets": "Hemoglobin ≥90 g/L",
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                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
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                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Hemoglobin ≥90 g/L",
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                            "requirement_type": "level",
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                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
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                ]
            }
        },
        {
            "identified_line": {
                "line": "Kidney function",
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                    {
                        "exact_snippets": "Kidney function",
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                            "requirement_type": "N/A",
                            "expected_value": "N/A"
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                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Kidney function",
                        "criterion": "kidney function",
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                            "requirement_type": "N/A",
                            "expected_value": "N/A"
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Serum creatinine <=1.5 x upper limit of normal (ULN) or Creatinine clearance is calculated with reference to the Cockcroft-Gault formula or the site practices ≥50 mL/min",
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                    {
                        "exact_snippets": "Serum creatinine <=1.5 x upper limit of normal (ULN)",
                        "criterion": "serum creatinine",
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                            "requirement_type": "level",
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                                "operator": "<=",
                                "value": 1.5,
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                    },
                    {
                        "exact_snippets": "Creatinine clearance ... Cockcroft-Gault formula ... ≥50 mL/min",
                        "criterion": "creatinine clearance",
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                            "requirement_type": "calculation method",
                            "expected_value": [
                                "Cockcroft-Gault formula",
                                "site practices"
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                    },
                    {
                        "exact_snippets": "Creatinine clearance ... Cockcroft-Gault formula ... ≥50 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "level",
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                                "operator": ">=",
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                ]
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Serum creatinine <=1.5 x upper limit of normal (ULN)",
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                                    "requirement_type": "level",
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                        ]
                    },
                    {
                        "and_criteria": [
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                                "exact_snippets": "Creatinine clearance ... Cockcroft-Gault formula ... ≥50 mL/min",
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                                    "requirement_type": "calculation method",
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                                        "Cockcroft-Gault formula",
                                        "site practices"
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                                        "value": 50,
                                        "unit": "mL/min"
                                    }
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                    }
                ]
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        },
        {
            "identified_line": {
                "line": "Hepatic function",
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                    {
                        "exact_snippets": "Hepatic function",
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                            "requirement_type": "N/A",
                            "expected_value": "N/A"
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                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Hepatic function",
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "total Bilirubin <=1.5 x ULN or<=3 x ULN (patients with known Gilbert's disease)",
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                    {
                        "exact_snippets": "total Bilirubin <=1.5 x ULN",
                        "criterion": "total Bilirubin",
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                            "requirement_type": "level",
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                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
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                    },
                    {
                        "exact_snippets": "total Bilirubin ... <=3 x ULN (patients with known Gilbert's disease)",
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                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
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                ]
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "total Bilirubin <=1.5 x ULN",
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                                    "requirement_type": "level",
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                                        "operator": "<=",
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                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "total Bilirubin ... <=3 x ULN (patients with known Gilbert's disease)",
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                                        "requirement_type": "level",
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                                            "operator": "<=",
                                            "value": 3,
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                                }
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                        ]
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "total Bilirubin ... <=3 x ULN (patients with known Gilbert's disease)",
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                                    "requirement_type": "level",
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                                        "operator": "<=",
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                            {
                                "not_criteria": {
                                    "exact_snippets": "total Bilirubin <=1.5 x ULN",
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                                            "operator": "<=",
                                            "value": 1.5,
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                        ]
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                ]
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        },
        {
            "identified_line": {
                "line": "ALT/AST <=3 x ULN (without liver metastasis) or<=5 x ULN (in case of liver metastases)",
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                        "criterion": "ALT/AST levels without liver metastasis",
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                            "requirement_type": "level",
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                                "operator": "<=",
                                "value": 3,
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                    {
                        "exact_snippets": "ALT/AST ... <=5 x ULN (in case of liver metastases)",
                        "criterion": "ALT/AST levels with liver metastasis",
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                            "requirement_type": "level",
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                                "operator": "<=",
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                                "unit": "x ULN"
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                ]
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                    "exact_snippets": "ALT/AST <=3 x ULN (without liver metastasis)",
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                        "requirement_type": "level",
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                            "operator": "<=",
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                        "requirement_type": "level",
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        },
        {
            "identified_line": {
                "line": "Albumin (no infusion of albumin product with 14 days prior to the first dose of the investigational medical product)≥30g/L",
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                        "exact_snippets": "Albumin ... ≥30g/L",
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                            "requirement_type": "level",
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                                "operator": ">=",
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                    {
                        "exact_snippets": "no infusion of albumin product with 14 days prior to the first dose of the investigational medical product",
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                            "requirement_type": "time since last infusion",
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                                "operator": ">=",
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                        "exact_snippets": "Albumin ... ≥30g/L",
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                            "requirement_type": "level",
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                                "operator": ">=",
                                "value": 30,
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                    {
                        "exact_snippets": "no infusion of albumin product with 14 days prior to the first dose of the investigational medical product",
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                            "requirement_type": "time since last infusion",
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                                "operator": ">=",
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        },
        {
            "identified_line": {
                "line": "Coagulation function",
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                    {
                        "exact_snippets": "Coagulation function",
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                            "expected_value": "N/A"
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                    }
                ]
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                    {
                        "exact_snippets": "Coagulation function",
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                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
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        },
        {
            "identified_line": {
                "line": "International normalized ratio (INR)",
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                    {
                        "exact_snippets": "International normalized ratio (INR)",
                        "criterion": "International normalized ratio (INR)",
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                            "requirement_type": "presence",
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                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "International normalized ratio (INR)",
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                            "requirement_type": "presence",
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Prothrombin Time (PT)",
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                    {
                        "exact_snippets": "Prothrombin Time (PT)",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prothrombin Time (PT)",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Activated Partial Thromboplastin Time (aPTT) <=1.5 x ULN",
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                    {
                        "exact_snippets": "Activated Partial Thromboplastin Time (aPTT) <=1.5 x ULN",
                        "criterion": "Activated Partial Thromboplastin Time (aPTT)",
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                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
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                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Activated Partial Thromboplastin Time (aPTT) <=1.5 x ULN",
                        "criterion": "Activated Partial Thromboplastin Time (aPTT)",
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                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Within 72 h prior to the first dose, for women of childbearing age must confirm that the serum pregnancy test is negative and agree to adopt effective contraceptive measures during use of the investigational medical product and for 5 months after last dose. A female of childbearing potential in this Protocol is defined as a sexually mature female who:",
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                    {
                        "exact_snippets": "Within 72 h prior to the first dose, for women of childbearing age must confirm that the serum pregnancy test is negative",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "agree to adopt effective contraceptive measures during use of the investigational medical product and for 5 months after last dose",
                        "criterion": "contraceptive measures",
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                            "requirement_type": "adoption",
                            "expected_value": true
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                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Within 72 h prior to the first dose, for women of childbearing age must confirm that the serum pregnancy test is negative",
                                "criterion": "serum pregnancy test",
                                "requirement": {
                                    "requirement_type": "result",
                                    "expected_value": "negative"
                                }
                            },
                            {
                                "exact_snippets": "agree to adopt effective contraceptive measures during use of the investigational medical product and for 5 months after last dose",
                                "criterion": "contraceptive measures",
                                "requirement": {
                                    "requirement_type": "adoption",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1) No hysterectomy or bilateral oophorectomy, 2) Spontaneous menopause does not last for 24 consecutive months (amenorrhea after cancer treatment does not rule out fertility) (i.e., menstruation at any time within the previous 24 consecutive months).",
                "criterions": [
                    {
                        "exact_snippets": "No hysterectomy",
                        "criterion": "hysterectomy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... bilateral oophorectomy",
                        "criterion": "bilateral oophorectomy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Spontaneous menopause does not last for 24 consecutive months",
                        "criterion": "spontaneous menopause duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 24,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "menstruation at any time within the previous 24 consecutive months",
                        "criterion": "menstruation",
                        "requirement": {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 24,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "No hysterectomy",
                                "criterion": "hysterectomy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "No ... bilateral oophorectomy",
                                "criterion": "bilateral oophorectomy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Spontaneous menopause does not last for 24 consecutive months",
                                "criterion": "spontaneous menopause duration",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<",
                                                "value": 24,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "menstruation at any time within the previous 24 consecutive months",
                                "criterion": "menstruation",
                                "requirement": {
                                    "requirement_type": "occurrence",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 24,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Male patients with partners of childbearing potential must agree to use effective contraception during the use of the investigational medical product and for 5 months after last dose.",
                "criterions": [
                    {
                        "exact_snippets": "Male patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": "partners of childbearing potential",
                        "criterion": "partner's childbearing potential",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "childbearing potential"
                        }
                    },
                    {
                        "exact_snippets": "must agree to use effective contraception",
                        "criterion": "contraception agreement",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "during the use of the investigational medical product and for 5 months after last dose",
                        "criterion": "contraception duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the use of the investigational medical product and for 5 months after last dose"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Male patients",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "expected_value",
                                    "expected_value": "male"
                                }
                            },
                            {
                                "exact_snippets": "partners of childbearing potential",
                                "criterion": "partner's childbearing potential",
                                "requirement": {
                                    "requirement_type": "expected_value",
                                    "expected_value": "childbearing potential"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "must agree to use effective contraception",
                                "criterion": "contraception agreement",
                                "requirement": {
                                    "requirement_type": "expected_value",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "during the use of the investigational medical product and for 5 months after last dose",
                                "criterion": "contraception duration",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": "during the use of the investigational medical product and for 5 months after last dose"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Nasopharyngeal cancer or salivary gland cancer confirmed histologically or cytologically, or other non-squamous cell cancer (e.g., adenocarcinoma, sarcoma, or mixed cancer), or metastatic squamous cell cancer with unknown primary site.",
                "criterions": [
                    {
                        "exact_snippets": "Nasopharyngeal cancer ... confirmed histologically or cytologically",
                        "criterion": "nasopharyngeal cancer",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "salivary gland cancer confirmed histologically or cytologically",
                        "criterion": "salivary gland cancer",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "other non-squamous cell cancer (e.g., adenocarcinoma, sarcoma, or mixed cancer)",
                        "criterion": "non-squamous cell cancer",
                        "requirement": {
                            "requirement_type": "examples",
                            "expected_value": [
                                "adenocarcinoma",
                                "sarcoma",
                                "mixed cancer"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "metastatic squamous cell cancer with unknown primary site",
                        "criterion": "metastatic squamous cell cancer",
                        "requirement": {
                            "requirement_type": "primary site",
                            "expected_value": "unknown"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Nasopharyngeal cancer ... confirmed histologically or cytologically",
                                "criterion": "nasopharyngeal cancer",
                                "requirement": {
                                    "requirement_type": "confirmation method",
                                    "expected_value": [
                                        "histologically",
                                        "cytologically"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "salivary gland cancer confirmed histologically or cytologically",
                                "criterion": "salivary gland cancer",
                                "requirement": {
                                    "requirement_type": "confirmation method",
                                    "expected_value": [
                                        "histologically",
                                        "cytologically"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "other non-squamous cell cancer (e.g., adenocarcinoma, sarcoma, or mixed cancer)",
                                "criterion": "non-squamous cell cancer",
                                "requirement": {
                                    "requirement_type": "examples",
                                    "expected_value": [
                                        "adenocarcinoma",
                                        "sarcoma",
                                        "mixed cancer"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "metastatic squamous cell cancer with unknown primary site",
                                "criterion": "metastatic squamous cell cancer",
                                "requirement": {
                                    "requirement_type": "primary site",
                                    "expected_value": "unknown"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patients with necrotic lesion, at risk for major hemorrhage as judged by the investigator.",
                "criterions": [
                    {
                        "exact_snippets": "Patients with necrotic lesion",
                        "criterion": "necrotic lesion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "at risk for major hemorrhage",
                        "criterion": "risk for major hemorrhage",
                        "requirement": {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Patients with necrotic lesion",
                        "criterion": "necrotic lesion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "at risk for major hemorrhage",
                        "criterion": "risk for major hemorrhage",
                        "requirement": {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Previously receiving other immune checkpoint inhibitors/drugs acting on immune checkpoint pathway/other drugs acting on T cell costimulation (e.g.: PD-1/PD-L1 antibody or CTLA-4 antibody);",
                "criterions": [
                    {
                        "exact_snippets": "Previously receiving other immune checkpoint inhibitors",
                        "criterion": "previous treatment with immune checkpoint inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "drugs acting on immune checkpoint pathway",
                        "criterion": "previous treatment with drugs acting on immune checkpoint pathway",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other drugs acting on T cell costimulation",
                        "criterion": "previous treatment with drugs acting on T cell costimulation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PD-1/PD-L1 antibody",
                        "criterion": "previous treatment with PD-1/PD-L1 antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "CTLA-4 antibody",
                        "criterion": "previous treatment with CTLA-4 antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Previously receiving other immune checkpoint inhibitors",
                                "criterion": "previous treatment with immune checkpoint inhibitors",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "drugs acting on immune checkpoint pathway",
                                "criterion": "previous treatment with drugs acting on immune checkpoint pathway",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "other drugs acting on T cell costimulation",
                                "criterion": "previous treatment with drugs acting on T cell costimulation",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "PD-1/PD-L1 antibody",
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                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "CTLA-4 antibody",
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                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Previous treatment of EGFR inhibitor (including radiotherapy sensitization therapy);",
                "criterions": [
                    {
                        "exact_snippets": "Previous treatment of EGFR inhibitor",
                        "criterion": "EGFR inhibitor treatment",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "including radiotherapy sensitization therapy",
                        "criterion": "radiotherapy sensitization therapy",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Previous treatment of EGFR inhibitor",
                        "criterion": "EGFR inhibitor treatment",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "including radiotherapy sensitization therapy",
                        "criterion": "radiotherapy sensitization therapy",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Diagnosed with other malignancies within 5 years prior to study entry, except for basal cell carcinoma of the skin or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or carcinoma in situ of the breast that can be cured by local therapy",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosed with other malignancies within 5 years prior to study entry",
                        "criterion": "other malignancies",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Diagnosed with other malignancies within 5 years prior to study entry",
                        "criterion": "other malignancies",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "except for basal cell carcinoma of the skin",
                        "criterion": "basal cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except for ... squamous cell carcinoma",
                        "criterion": "squamous cell carcinoma",
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                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except for ... superficial bladder cancer",
                        "criterion": "superficial bladder cancer",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except for ... carcinoma in situ of the cervix",
                        "criterion": "carcinoma in situ of the cervix",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except for ... carcinoma in situ of the breast",
                        "criterion": "carcinoma in situ of the breast",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
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                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Diagnosed with other malignancies within 5 years prior to study entry",
                                    "criterion": "other malignancies",
                                    "requirement": {
                                        "requirement_type": "diagnosis",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "Diagnosed with other malignancies within 5 years prior to study entry",
                                    "criterion": "other malignancies",
                                    "requirement": {
                                        "requirement_type": "time frame",
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                                            "comparisons": [
                                                {
                                                    "operator": "<=",
                                                    "value": 5,
                                                    "unit": "years"
                                                }
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                            {
                                "exact_snippets": "except for basal cell carcinoma of the skin",
                                "criterion": "basal cell carcinoma of the skin",
                                "requirement": {
                                    "requirement_type": "exclusion",
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                                }
                            },
                            {
                                "exact_snippets": "except for ... squamous cell carcinoma",
                                "criterion": "squamous cell carcinoma",
                                "requirement": {
                                    "requirement_type": "exclusion",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "except for ... superficial bladder cancer",
                                "criterion": "superficial bladder cancer",
                                "requirement": {
                                    "requirement_type": "exclusion",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "except for ... carcinoma in situ of the cervix",
                                "criterion": "carcinoma in situ of the cervix",
                                "requirement": {
                                    "requirement_type": "exclusion",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "except for ... carcinoma in situ of the breast",
                                "criterion": "carcinoma in situ of the breast",
                                "requirement": {
                                    "requirement_type": "exclusion",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "7. Poorly controlled hydrothorax, hydrops abdominis, or pericardial effusion;",
                "criterions": [
                    {
                        "exact_snippets": "Poorly controlled hydrothorax",
                        "criterion": "hydrothorax",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    },
                    {
                        "exact_snippets": "Poorly controlled ... hydrops abdominis",
                        "criterion": "hydrops abdominis",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    },
                    {
                        "exact_snippets": "Poorly controlled ... pericardial effusion",
                        "criterion": "pericardial effusion",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Poorly controlled hydrothorax",
                        "criterion": "hydrothorax",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    },
                    {
                        "exact_snippets": "Poorly controlled ... hydrops abdominis",
                        "criterion": "hydrops abdominis",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    },
                    {
                        "exact_snippets": "Poorly controlled ... pericardial effusion",
                        "criterion": "pericardial effusion",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Existing Grade >=2 (in accordance with NCI-CTCAE 5.0) peripheral neuropathy or hearing loss;",
                "criterions": [
                    {
                        "exact_snippets": "Existing Grade >=2 (in accordance with NCI-CTCAE 5.0) peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Existing Grade >=2 (in accordance with NCI-CTCAE 5.0) ... hearing loss",
                        "criterion": "hearing loss",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Existing Grade >=2 (in accordance with NCI-CTCAE 5.0) peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Existing Grade >=2 (in accordance with NCI-CTCAE 5.0) ... hearing loss",
                        "criterion": "hearing loss",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Pregnant or breastfeeding female subjects;",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. In the following cases within 6 months prior to the first dose: Myocardial infarction, serious/unstable angina, NYHA Grade >=2 cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, or symptomatic congestive heart failure;",
                "criterions": [
                    {
                        "exact_snippets": "Myocardial infarction ... within 6 months prior to the first dose",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months prior to the first dose"
                        }
                    },
                    {
                        "exact_snippets": "serious/unstable angina ... within 6 months prior to the first dose",
                        "criterion": "angina",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "serious",
                                "unstable"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "serious/unstable angina ... within 6 months prior to the first dose",
                        "criterion": "angina",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months prior to the first dose"
                        }
                    },
                    {
                        "exact_snippets": "NYHA Grade >=2 cardiac insufficiency ... within 6 months prior to the first dose",
                        "criterion": "cardiac insufficiency",
                        "requirement": {
                            "requirement_type": "NYHA Grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "NYHA Grade >=2 cardiac insufficiency ... within 6 months prior to the first dose",
                        "criterion": "cardiac insufficiency",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months prior to the first dose"
                        }
                    },
                    {
                        "exact_snippets": "clinically significant supraventricular or ventricular arrhythmia ... within 6 months prior to the first dose",
                        "criterion": "arrhythmia",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "supraventricular",
                                "ventricular"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "clinically significant supraventricular or ventricular arrhythmia ... within 6 months prior to the first dose",
                        "criterion": "arrhythmia",
                        "requirement": {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "clinically significant supraventricular or ventricular arrhythmia ... within 6 months prior to the first dose",
                        "criterion": "arrhythmia",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months prior to the first dose"
                        }
                    },
                    {
                        "exact_snippets": "symptomatic congestive heart failure ... within 6 months prior to the first dose",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "symptomatic congestive heart failure ... within 6 months prior to the first dose",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months prior to the first dose"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Myocardial infarction ... within 6 months prior to the first dose",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 6 months prior to the first dose"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "serious/unstable angina ... within 6 months prior to the first dose",
                                "criterion": "angina",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": [
                                        "serious",
                                        "unstable"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "serious/unstable angina ... within 6 months prior to the first dose",
                                "criterion": "angina",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 6 months prior to the first dose"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "NYHA Grade >=2 cardiac insufficiency ... within 6 months prior to the first dose",
                                "criterion": "cardiac insufficiency",
                                "requirement": {
                                    "requirement_type": "NYHA Grade",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "NYHA Grade >=2 cardiac insufficiency ... within 6 months prior to the first dose",
                                "criterion": "cardiac insufficiency",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 6 months prior to the first dose"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "clinically significant supraventricular or ventricular arrhythmia ... within 6 months prior to the first dose",
                                "criterion": "arrhythmia",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": [
                                        "supraventricular",
                                        "ventricular"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "clinically significant supraventricular or ventricular arrhythmia ... within 6 months prior to the first dose",
                                "criterion": "arrhythmia",
                                "requirement": {
                                    "requirement_type": "clinical significance",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "clinically significant supraventricular or ventricular arrhythmia ... within 6 months prior to the first dose",
                                "criterion": "arrhythmia",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 6 months prior to the first dose"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "symptomatic congestive heart failure ... within 6 months prior to the first dose",
                                "criterion": "congestive heart failure",
                                "requirement": {
                                    "requirement_type": "symptomatic",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "symptomatic congestive heart failure ... within 6 months prior to the first dose",
                                "criterion": "congestive heart failure",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 6 months prior to the first dose"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Note: Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction < 50% must be treated with an optimized stable medical regimen at the discretion of the treating physician, with consultation with a cardiologist, as appropriate;",
                "criterions": [
                    {
                        "exact_snippets": "known coronary artery disease",
                        "criterion": "coronary artery disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "congestive heart failure not meeting the above criteria",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "left ventricular ejection fraction < 50%",
                        "criterion": "left ventricular ejection fraction",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "known coronary artery disease",
                                "criterion": "coronary artery disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "congestive heart failure not meeting the above criteria",
                                "criterion": "congestive heart failure",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "left ventricular ejection fraction < 50%",
                        "criterion": "left ventricular ejection fraction",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Poorly controlled hypertension (systolic blood pressure (BP) >=160 mmHg and/or diastolic blood pressure >=100 mmHg) (based on the mean of >=3 BP readings obtained from >=2 measurements); hypertensive crisis or hypertensive encephalopathy within 6 months prior to the first dose.",
                "criterions": [
                    {
                        "exact_snippets": "Poorly controlled hypertension (systolic blood pressure (BP) >=160 mmHg and/or diastolic blood pressure >=100 mmHg)",
                        "criterion": "poorly controlled hypertension",
                        "requirement": {
                            "requirement_type": "systolic blood pressure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 160,
                                "unit": "mmHg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Poorly controlled hypertension (systolic blood pressure (BP) >=160 mmHg and/or diastolic blood pressure >=100 mmHg)",
                        "criterion": "poorly controlled hypertension",
                        "requirement": {
                            "requirement_type": "diastolic blood pressure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hypertensive crisis or hypertensive encephalopathy within 6 months prior to the first dose",
                        "criterion": "hypertensive crisis or hypertensive encephalopathy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months prior to the first dose"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Poorly controlled hypertension (systolic blood pressure (BP) >=160 mmHg and/or diastolic blood pressure >=100 mmHg)",
                                        "criterion": "poorly controlled hypertension",
                                        "requirement": {
                                            "requirement_type": "systolic blood pressure",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 160,
                                                "unit": "mmHg"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Poorly controlled hypertension (systolic blood pressure (BP) >=160 mmHg and/or diastolic blood pressure >=100 mmHg)",
                                        "criterion": "poorly controlled hypertension",
                                        "requirement": {
                                            "requirement_type": "diastolic blood pressure",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 100,
                                                "unit": "mmHg"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "hypertensive crisis or hypertensive encephalopathy within 6 months prior to the first dose",
                                "criterion": "hypertensive crisis or hypertensive encephalopathy",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 6 months prior to the first dose"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Patients with known allergy to the investigational medical product or any excipient, or with serious allergic reaction to other monoclonal antibodies;",
                "criterions": [
                    {
                        "exact_snippets": "known allergy to the investigational medical product",
                        "criterion": "allergy to investigational medical product",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "allergy to ... any excipient",
                        "criterion": "allergy to excipient",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "serious allergic reaction to other monoclonal antibodies",
                        "criterion": "serious allergic reaction to monoclonal antibodies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "known allergy to the investigational medical product",
                                "criterion": "allergy to investigational medical product",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "allergy to ... any excipient",
                                "criterion": "allergy to excipient",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "serious allergic reaction to other monoclonal antibodies",
                        "criterion": "serious allergic reaction to monoclonal antibodies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Receiving the following drugs or therapies prior to first dose of investigational medical product :",
                "criterions": [
                    {
                        "exact_snippets": "Receiving the following drugs or therapies",
                        "criterion": "prior therapies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Receiving the following drugs or therapies",
                        "criterion": "prior therapies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Major surgery within 28 d prior to the first dose of the investigational therapy (tissue biopsy required for diagnosis, and pieripherally inserted central catheter [PICC] or infusion port implantation are permissible).",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery within 28 d prior to the first dose of the investigational therapy",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "d"
                            }
                        }
                    },
                    {
                        "exact_snippets": "tissue biopsy required for diagnosis",
                        "criterion": "tissue biopsy",
                        "requirement": {
                            "requirement_type": "requirement for diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pieripherally inserted central catheter [PICC] or infusion port implantation are permissible",
                        "criterion": "PICC or infusion port implantation",
                        "requirement": {
                            "requirement_type": "permissibility",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Major surgery within 28 d prior to the first dose of the investigational therapy",
                            "criterion": "major surgery",
                            "requirement": {
                                "requirement_type": "time since",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 28,
                                    "unit": "d"
                                }
                            }
                        }
                    },
                    {
                        "exact_snippets": "tissue biopsy required for diagnosis",
                        "criterion": "tissue biopsy",
                        "requirement": {
                            "requirement_type": "requirement for diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pieripherally inserted central catheter [PICC] or infusion port implantation are permissible",
                        "criterion": "PICC or infusion port implantation",
                        "requirement": {
                            "requirement_type": "permissibility",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Antitumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, cytokine therapy, or biological therapy, etc.) with 28 d prior to the first dose of the investigational medical product;",
                "criterions": [
                    {
                        "exact_snippets": "Antitumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, cytokine therapy, or biological therapy, etc.)",
                        "criterion": "antitumor therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "28 d prior to the first dose of the investigational medical product",
                        "criterion": "time since last antitumor therapy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "d"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Antitumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, cytokine therapy, or biological therapy, etc.)",
                        "criterion": "antitumor therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "28 d prior to the first dose of the investigational medical product",
                        "criterion": "time since last antitumor therapy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "d"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Participation in other intervention studies within 28 d prior to the first dose of the investigational medical product;",
                "criterions": [
                    {
                        "exact_snippets": "Participation in other intervention studies within 28 d prior to the first dose",
                        "criterion": "participation in other intervention studies",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "d"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Participation in other intervention studies within 28 d prior to the first dose",
                    "criterion": "participation in other intervention studies",
                    "requirement": {
                        "requirement_type": "time frame",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 28,
                                    "unit": "d"
                                }
                            ]
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Treatment with a systemic immunostimulatory drug (including but not limited to interferon or IL-2) within 14 d or 5 half-lives of the investigational medicinal product (whichever is longer) prior to the first dose of the investigational medical product;",
                "criterions": [
                    {
                        "exact_snippets": "Treatment with a systemic immunostimulatory drug (including but not limited to interferon or IL-2)",
                        "criterion": "systemic immunostimulatory drug treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "within 14 d or 5 half-lives of the investigational medicinal product (whichever is longer) prior to the first dose of the investigational medical product",
                        "criterion": "time since last systemic immunostimulatory drug treatment",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 14,
                                        "unit": "d"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Treatment with a systemic immunostimulatory drug (including but not limited to interferon or IL-2)",
                                "criterion": "systemic immunostimulatory drug treatment",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "within 14 d or 5 half-lives of the investigational medicinal product (whichever is longer) prior to the first dose of the investigational medical product",
                                "criterion": "time since last systemic immunostimulatory drug treatment",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">",
                                                "value": 14,
                                                "unit": "d"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Treatment of a systemic corticosteroid (> 10 mg/d prednisone or equivalent drug) or other systemic immunosuppressive drugs (including but not limited to Cyclophosphamide, Azathioprine, Methotrexate, Thalidomide and anti-tumor necrosis factor drugs [anti-TNF]) within 14 d prior to the first dose of the investigational therapy;",
                "criterions": [
                    {
                        "exact_snippets": "Treatment of a systemic corticosteroid (> 10 mg/d prednisone or equivalent drug)",
                        "criterion": "systemic corticosteroid treatment",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/d prednisone or equivalent drug"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Treatment of a systemic corticosteroid (> 10 mg/d prednisone or equivalent drug)",
                        "criterion": "systemic corticosteroid treatment",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "within 14 d prior to the first dose of the investigational therapy"
                        }
                    },
                    {
                        "exact_snippets": "other systemic immunosuppressive drugs (including but not limited to Cyclophosphamide, Azathioprine, Methotrexate, Thalidomide and anti-tumor necrosis factor drugs [anti-TNF])",
                        "criterion": "systemic immunosuppressive drug treatment",
                        "requirement": {
                            "requirement_type": "drug types",
                            "expected_value": [
                                "Cyclophosphamide",
                                "Azathioprine",
                                "Methotrexate",
                                "Thalidomide",
                                "anti-tumor necrosis factor drugs [anti-TNF]"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "other systemic immunosuppressive drugs (including but not limited to Cyclophosphamide, Azathioprine, Methotrexate, Thalidomide and anti-tumor necrosis factor drugs [anti-TNF])",
                        "criterion": "systemic immunosuppressive drug treatment",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "within 14 d prior to the first dose of the investigational therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Treatment of a systemic corticosteroid (> 10 mg/d prednisone or equivalent drug)",
                                        "criterion": "systemic corticosteroid treatment",
                                        "requirement": {
                                            "requirement_type": "dosage",
                                            "expected_value": {
                                                "operator": ">",
                                                "value": 10,
                                                "unit": "mg/d prednisone or equivalent drug"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Treatment of a systemic corticosteroid (> 10 mg/d prednisone or equivalent drug)",
                                        "criterion": "systemic corticosteroid treatment",
                                        "requirement": {
                                            "requirement_type": "timeframe",
                                            "expected_value": "within 14 d prior to the first dose of the investigational therapy"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "other systemic immunosuppressive drugs (including but not limited to Cyclophosphamide, Azathioprine, Methotrexate, Thalidomide and anti-tumor necrosis factor drugs [anti-TNF])",
                                        "criterion": "systemic immunosuppressive drug treatment",
                                        "requirement": {
                                            "requirement_type": "drug types",
                                            "expected_value": [
                                                "Cyclophosphamide",
                                                "Azathioprine",
                                                "Methotrexate",
                                                "Thalidomide",
                                                "anti-tumor necrosis factor drugs [anti-TNF]"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "other systemic immunosuppressive drugs (including but not limited to Cyclophosphamide, Azathioprine, Methotrexate, Thalidomide and anti-tumor necrosis factor drugs [anti-TNF])",
                                        "criterion": "systemic immunosuppressive drug treatment",
                                        "requirement": {
                                            "requirement_type": "timeframe",
                                            "expected_value": "within 14 d prior to the first dose of the investigational therapy"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "o Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are permitted;",
                "criterions": [
                    {
                        "exact_snippets": "Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are permitted",
                        "criterion": "corticosteroid administration route",
                        "requirement": {
                            "requirement_type": "permitted routes",
                            "expected_value": [
                                "topical",
                                "ocular",
                                "intra-articular",
                                "intranasal",
                                "inhaled"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are permitted",
                        "criterion": "corticosteroid administration route",
                        "requirement": {
                            "requirement_type": "permitted routes",
                            "expected_value": [
                                "topical",
                                "ocular",
                                "intra-articular",
                                "intranasal",
                                "inhaled"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients receiving an acute low-dose systemic immunosuppressive agent (e.g., a single dose of dexamethasone for nausea, or preventive medication prior to administration of Cetuximab ) may be enrolled after discussion with and approval by the medical monitor;",
                "criterions": [
                    {
                        "exact_snippets": "Patients receiving an acute low-dose systemic immunosuppressive agent",
                        "criterion": "acute low-dose systemic immunosuppressive agent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "may be enrolled after discussion with and approval by the medical monitor",
                        "criterion": "approval by the medical monitor",
                        "requirement": {
                            "requirement_type": "approval",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients receiving an acute low-dose systemic immunosuppressive agent",
                                "criterion": "acute low-dose systemic immunosuppressive agent",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "may be enrolled after discussion with and approval by the medical monitor",
                                "criterion": "approval by the medical monitor",
                                "requirement": {
                                    "requirement_type": "approval",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients who need baseline and follow-up MRI/CT tumor assessment can use steroids prophylaxis if they have previous allergic reactions to intravenous contrast media.",
                "criterions": [
                    {
                        "exact_snippets": "Patients who need baseline and follow-up MRI/CT tumor assessment",
                        "criterion": "MRI/CT tumor assessment",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "can use steroids prophylaxis if they have previous allergic reactions to intravenous contrast media",
                        "criterion": "previous allergic reactions to intravenous contrast media",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Patients who need baseline and follow-up MRI/CT tumor assessment",
                            "criterion": "MRI/CT tumor assessment",
                            "requirement": {
                                "requirement_type": "necessity",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "can use steroids prophylaxis if they have previous allergic reactions to intravenous contrast media",
                            "criterion": "previous allergic reactions to intravenous contrast media",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "can use steroids prophylaxis if they have previous allergic reactions to intravenous contrast media",
                    "criterion": "steroids prophylaxis",
                    "requirement": {
                        "requirement_type": "usage",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension, and low-dose corticosteroids for maintenance treatment of adrenocortical insufficiency are permitted;",
                "criterions": [
                    {
                        "exact_snippets": "Inhaled corticosteroids for chronic obstructive pulmonary disease ... are permitted",
                        "criterion": "inhaled corticosteroids for chronic obstructive pulmonary disease",
                        "requirement": {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension ... are permitted",
                        "criterion": "mineralocorticoids for orthostatic hypotension",
                        "requirement": {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "low-dose corticosteroids for maintenance treatment of adrenocortical insufficiency are permitted",
                        "criterion": "low-dose corticosteroids for maintenance treatment of adrenocortical insufficiency",
                        "requirement": {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Inhaled corticosteroids for chronic obstructive pulmonary disease ... are permitted",
                        "criterion": "inhaled corticosteroids for chronic obstructive pulmonary disease",
                        "requirement": {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension ... are permitted",
                        "criterion": "mineralocorticoids for orthostatic hypotension",
                        "requirement": {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "low-dose corticosteroids for maintenance treatment of adrenocortical insufficiency are permitted",
                        "criterion": "low-dose corticosteroids for maintenance treatment of adrenocortical insufficiency",
                        "requirement": {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Treatment of oral or intravenous antibiotic therapy (except preventive use of antibiotics) with 14 d prior to the first dose of the investigational therapy;",
                "criterions": [
                    {
                        "exact_snippets": "Treatment of oral or intravenous antibiotic therapy ... with 14 d prior to the first dose of the investigational therapy",
                        "criterion": "antibiotic therapy",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Treatment of oral or intravenous antibiotic therapy ... with 14 d prior to the first dose of the investigational therapy",
                        "criterion": "antibiotic therapy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "d"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Treatment of oral or intravenous antibiotic therapy ... with 14 d prior to the first dose of the investigational therapy",
                        "criterion": "antibiotic therapy",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Treatment of oral or intravenous antibiotic therapy ... with 14 d prior to the first dose of the investigational therapy",
                        "criterion": "antibiotic therapy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "d"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Vaccination of any live vaccine (e.g., vaccine against infectious diseases, such as influenza vaccine or varicella vaccine, etc.) within 28 d prior to the first dose of the investigational medical product;",
                "criterions": [
                    {
                        "exact_snippets": "Vaccination of any live vaccine ... within 28 d prior to the first dose",
                        "criterion": "live vaccine vaccination",
                        "requirement": {
                            "requirement_type": "time since vaccination",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "d"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Vaccination of any live vaccine ... within 28 d prior to the first dose",
                    "criterion": "live vaccine vaccination",
                    "requirement": {
                        "requirement_type": "time since vaccination",
                        "expected_value": {
                            "operator": "<",
                            "value": 28,
                            "unit": "d"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "14. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-related vascular thrombosis, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, glomerulonephritis;",
                "criterions": [
                    {
                        "exact_snippets": "History of autoimmune disease",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "myasthenia gravis",
                        "criterion": "myasthenia gravis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "myositis",
                        "criterion": "myositis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "autoimmune hepatitis",
                        "criterion": "autoimmune hepatitis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "systemic lupus erythematosus",
                        "criterion": "systemic lupus erythematosus",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "rheumatoid arthritis",
                        "criterion": "rheumatoid arthritis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "inflammatory bowel disease",
                        "criterion": "inflammatory bowel disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "antiphospholipid syndrome-related vascular thrombosis",
                        "criterion": "antiphospholipid syndrome-related vascular thrombosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Wegener's granulomatosis",
                        "criterion": "Wegener's granulomatosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Sjogren's syndrome",
                        "criterion": "Sjogren's syndrome",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Guillain-Barre syndrome",
                        "criterion": "Guillain-Barre syndrome",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "multiple sclerosis",
                        "criterion": "multiple sclerosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "vasculitis",
                        "criterion": "vasculitis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "glomerulonephritis",
                        "criterion": "glomerulonephritis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of autoimmune disease",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "myasthenia gravis",
                        "criterion": "myasthenia gravis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "myositis",
                        "criterion": "myositis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "autoimmune hepatitis",
                        "criterion": "autoimmune hepatitis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "systemic lupus erythematosus",
                        "criterion": "systemic lupus erythematosus",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "rheumatoid arthritis",
                        "criterion": "rheumatoid arthritis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "inflammatory bowel disease",
                        "criterion": "inflammatory bowel disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "antiphospholipid syndrome-related vascular thrombosis",
                        "criterion": "antiphospholipid syndrome-related vascular thrombosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Wegener's granulomatosis",
                        "criterion": "Wegener's granulomatosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Sjogren's syndrome",
                        "criterion": "Sjogren's syndrome",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Guillain-Barre syndrome",
                        "criterion": "Guillain-Barre syndrome",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "multiple sclerosis",
                        "criterion": "multiple sclerosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "vasculitis",
                        "criterion": "vasculitis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "glomerulonephritis",
                        "criterion": "glomerulonephritis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Patients with autoimmune-related hypothyroidism on a stable dose of thyroid hormone replacement are eligible;",
                "criterions": [
                    {
                        "exact_snippets": "Patients with autoimmune-related hypothyroidism",
                        "criterion": "autoimmune-related hypothyroidism",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "on a stable dose of thyroid hormone replacement",
                        "criterion": "thyroid hormone replacement",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "stable dose"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients with autoimmune-related hypothyroidism",
                        "criterion": "autoimmune-related hypothyroidism",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "on a stable dose of thyroid hormone replacement",
                        "criterion": "thyroid hormone replacement",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "stable dose"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patients with type 1 diabetes who are controlled after receiving a stable insulin regimen are eligible for this study;",
                "criterions": [
                    {
                        "exact_snippets": "Patients with type 1 diabetes",
                        "criterion": "type 1 diabetes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "controlled after receiving a stable insulin regimen",
                        "criterion": "diabetes control",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients with type 1 diabetes",
                        "criterion": "type 1 diabetes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "controlled after receiving a stable insulin regimen",
                        "criterion": "diabetes control",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "15. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;",
                "criterions": [
                    {
                        "exact_snippets": "Known history of allogeneic organ transplantation",
                        "criterion": "allogeneic organ transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known history of ... allogeneic hematopoietic stem cell transplantation",
                        "criterion": "allogeneic hematopoietic stem cell transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Known history of allogeneic organ transplantation",
                        "criterion": "allogeneic organ transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known history of ... allogeneic hematopoietic stem cell transplantation",
                        "criterion": "allogeneic hematopoietic stem cell transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "16. Serious infection (NCI-CTCAE Grade >2) within 28 d prior to the first dose of the investigational therapy, e.g., serious pneumonia requiring hospitalization, bacteremia, or infection complications, etc.",
                "criterions": [
                    {
                        "exact_snippets": "Serious infection (NCI-CTCAE Grade >2) within 28 d prior to the first dose of the investigational therapy",
                        "criterion": "serious infection",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "NCI-CTCAE Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Serious infection (NCI-CTCAE Grade >2) within 28 d prior to the first dose of the investigational therapy",
                        "criterion": "serious infection",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 28 d prior to the first dose of the investigational therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Serious infection (NCI-CTCAE Grade >2) within 28 d prior to the first dose of the investigational therapy",
                                "criterion": "serious infection",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 2,
                                        "unit": "NCI-CTCAE Grade"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Serious infection (NCI-CTCAE Grade >2) within 28 d prior to the first dose of the investigational therapy",
                                "criterion": "serious infection",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 28 d prior to the first dose of the investigational therapy"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "17. Active infection, including but not limited to tuberculosis (clinical diagnosis including clinical history, physical examination and imaging findings, and TB screening according to local medical routine), hepatitis B, hepatitis C or human immunodeficiency virus (HIV antibody positive);",
                "criterions": [
                    {
                        "exact_snippets": "Active infection, including but not limited to tuberculosis",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "tuberculosis (clinical diagnosis including clinical history, physical examination and imaging findings, and TB screening according to local medical routine)",
                        "criterion": "tuberculosis",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": "clinical"
                        }
                    },
                    {
                        "exact_snippets": "hepatitis B",
                        "criterion": "hepatitis B",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hepatitis C",
                        "criterion": "hepatitis C",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "human immunodeficiency virus (HIV antibody positive)",
                        "criterion": "HIV antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Active infection, including but not limited to tuberculosis",
                                "criterion": "active infection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "tuberculosis (clinical diagnosis including clinical history, physical examination and imaging findings, and TB screening according to local medical routine)",
                                "criterion": "tuberculosis",
                                "requirement": {
                                    "requirement_type": "diagnosis",
                                    "expected_value": "clinical"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "hepatitis B",
                        "criterion": "hepatitis B",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hepatitis C",
                        "criterion": "hepatitis C",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "human immunodeficiency virus (HIV antibody positive)",
                        "criterion": "HIV antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Patients who are positive for hepatitis B surface antigen (HBsAg+) and/or hepatitis B core antibody (HBcAb+) are required to undergo hepatitis B virus deoxyribonucleic acid (HBV DNA) test. If HBV DNA copy number is ˂1000 cps/mL or <200 IU/mL, or less than the lower limit of detectable value at the study site, the patients are eligible to participate in this study;",
                "criterions": [
                    {
                        "exact_snippets": "positive for hepatitis B surface antigen (HBsAg+)",
                        "criterion": "hepatitis B surface antigen",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive for ... hepatitis B core antibody (HBcAb+)",
                        "criterion": "hepatitis B core antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HBV DNA copy number is ˂1000 cps/mL",
                        "criterion": "HBV DNA copy number",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "cps/mL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "HBV DNA copy number is ... <200 IU/mL",
                        "criterion": "HBV DNA copy number",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 200,
                                "unit": "IU/mL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "HBV DNA copy number is ... less than the lower limit of detectable value at the study site",
                        "criterion": "HBV DNA copy number",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": "less than the lower limit of detectable value at the study site"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "or_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "positive for hepatitis B surface antigen (HBsAg+)",
                                    "criterion": "hepatitis B surface antigen",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "HBV DNA copy number is ˂1000 cps/mL",
                                    "criterion": "HBV DNA copy number",
                                    "requirement": {
                                        "requirement_type": "quantity",
                                        "expected_value": {
                                            "operator": "<",
                                            "value": 1000,
                                            "unit": "cps/mL"
                                        }
                                    }
                                }
                            ]
                        },
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "positive for ... hepatitis B core antibody (HBcAb+)",
                                    "criterion": "hepatitis B core antibody",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "HBV DNA copy number is ... <200 IU/mL",
                                    "criterion": "HBV DNA copy number",
                                    "requirement": {
                                        "requirement_type": "quantity",
                                        "expected_value": {
                                            "operator": "<",
                                            "value": 200,
                                            "unit": "IU/mL"
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": {
                    "or_criteria": [
                        {
                            "exact_snippets": "HBV DNA copy number is ˂1000 cps/mL",
                            "criterion": "HBV DNA copy number",
                            "requirement": {
                                "requirement_type": "quantity",
                                "expected_value": {
                                    "operator": "<",
                                    "value": 1000,
                                    "unit": "cps/mL"
                                }
                            }
                        },
                        {
                            "exact_snippets": "HBV DNA copy number is ... <200 IU/mL",
                            "criterion": "HBV DNA copy number",
                            "requirement": {
                                "requirement_type": "quantity",
                                "expected_value": {
                                    "operator": "<",
                                    "value": 200,
                                    "unit": "IU/mL"
                                }
                            }
                        },
                        {
                            "exact_snippets": "HBV DNA copy number is ... less than the lower limit of detectable value at the study site",
                            "criterion": "HBV DNA copy number",
                            "requirement": {
                                "requirement_type": "quantity",
                                "expected_value": "less than the lower limit of detectable value at the study site"
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "2. Patients who are positive for hepatitis C antibody (HCV Ab+) are required to have an HCV RNA test and are eligible for this study only if they are negative for HCV RNA (defined as below the lower limit of detectable value at the research site);",
                "criterions": [
                    {
                        "exact_snippets": "positive for hepatitis C antibody (HCV Ab+)",
                        "criterion": "hepatitis C antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HCV RNA test ... negative for HCV RNA (defined as below the lower limit of detectable value at the research site)",
                        "criterion": "HCV RNA",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "positive for hepatitis C antibody (HCV Ab+)",
                    "criterion": "hepatitis C antibody",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "exact_snippets": "HCV RNA test ... negative for HCV RNA (defined as below the lower limit of detectable value at the research site)",
                    "criterion": "HCV RNA",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "18. Idiopathic pulmonary fibrosis, drug-induced pneumonia, organized pneumonia (i.e., bronchiolitis obliterans), clinically symptomatic radiation pneumonia or active pneumonia, or those requiring steroid therapy, or other moderate to severe pulmonary diseases influencing seriously pulmonary function.",
                "criterions": [
                    {
                        "exact_snippets": "Idiopathic pulmonary fibrosis",
                        "criterion": "idiopathic pulmonary fibrosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "drug-induced pneumonia",
                        "criterion": "drug-induced pneumonia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "organized pneumonia (i.e., bronchiolitis obliterans)",
                        "criterion": "organized pneumonia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "clinically symptomatic radiation pneumonia",
                        "criterion": "radiation pneumonia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "active pneumonia",
                        "criterion": "active pneumonia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "requiring steroid therapy",
                        "criterion": "steroid therapy",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "other moderate to severe pulmonary diseases influencing seriously pulmonary function",
                        "criterion": "moderate to severe pulmonary diseases",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "moderate to severe"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Idiopathic pulmonary fibrosis",
                                "criterion": "idiopathic pulmonary fibrosis",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "drug-induced pneumonia",
                                "criterion": "drug-induced pneumonia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "organized pneumonia (i.e., bronchiolitis obliterans)",
                                "criterion": "organized pneumonia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "clinically symptomatic radiation pneumonia",
                                "criterion": "radiation pneumonia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "active pneumonia",
                                "criterion": "active pneumonia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "requiring steroid therapy",
                                "criterion": "steroid therapy",
                                "requirement": {
                                    "requirement_type": "requirement",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "other moderate to severe pulmonary diseases influencing seriously pulmonary function",
                                "criterion": "moderate to severe pulmonary diseases",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "moderate to severe"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "19. Patients with existing other serious physical or mental disorders or laboratory test abnormalities, or alcoholism or drug abuse, etc., that may increase the risk for participation in the study, influence compliance to the treatment, or interference the study results, or other conditions that are not suitable for participation in the study, as judged by the investigator",
                "criterions": [
                    {
                        "exact_snippets": "existing other serious physical or mental disorders",
                        "criterion": "serious physical or mental disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "laboratory test abnormalities",
                        "criterion": "laboratory test abnormalities",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "alcoholism",
                        "criterion": "alcoholism",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "drug abuse",
                        "criterion": "drug abuse",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "existing other serious physical or mental disorders",
                                        "criterion": "serious physical or mental disorders",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "laboratory test abnormalities",
                                        "criterion": "laboratory test abnormalities",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "alcoholism",
                                        "criterion": "alcoholism",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "drug abuse",
                                        "criterion": "drug abuse",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "...other conditions that are not suitable for participation in the study, as judged by the investigator",
                        "criterion": "suitability for participation",
                        "requirement": {
                            "requirement_type": "judgment",
                            "expected_value": "suitable"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Exclusion criteria：",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "Hematology (no blood transfusion or colony-stimulating factor or other drug correction within 14 days prior to the first study dose)",
                "criterions": [
                    {
                        "exact_snippets": "Hematology (no blood transfusion ... within 14 days prior to the first study dose)",
                        "criterion": "blood transfusion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Hematology (no ... colony-stimulating factor ... within 14 days prior to the first study dose)",
                        "criterion": "colony-stimulating factor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Hematology (no ... other drug correction within 14 days prior to the first study dose)",
                        "criterion": "other drug correction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Hematology (no blood transfusion ... within 14 days prior to the first study dose)",
                            "criterion": "blood transfusion",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Hematology (no ... colony-stimulating factor ... within 14 days prior to the first study dose)",
                            "criterion": "colony-stimulating factor",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Hematology (no ... other drug correction within 14 days prior to the first study dose)",
                            "criterion": "other drug correction",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Existing uncontrollable or symptomatic active central nervous system (CNS) metastasis, that may be characterized by clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, pia mater disease, and/or progressive growth;",
                "criterions": [
                    {
                        "exact_snippets": "Existing uncontrollable or symptomatic active central nervous system (CNS) metastasis",
                        "criterion": "central nervous system (CNS) metastasis",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Existing uncontrollable or symptomatic active central nervous system (CNS) metastasis",
                        "criterion": "central nervous system (CNS) metastasis",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Existing uncontrollable or symptomatic active central nervous system (CNS) metastasis",
                        "criterion": "central nervous system (CNS) metastasis",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "clinical symptoms",
                        "criterion": "clinical symptoms",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "cerebral edema",
                        "criterion": "cerebral edema",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "spinal cord compression",
                        "criterion": "spinal cord compression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "cancerous meningitis",
                        "criterion": "cancerous meningitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pia mater disease",
                        "criterion": "pia mater disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "progressive growth",
                        "criterion": "progressive growth",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "1) Patients with asymptomatic spinal cord compression indicated radiologically may be enrolled, if assessed as stable by the specialist and requiring no treatment presently; 2) Patients who have previously received treatment for CNS metastases, and become stable for >=4 weeks as indicated radiologically in the screening period, and stopped systemic hormone therapy (prednisone in a dose >10 mg/d or an equivalent hormone) for >=4 weeks prior to the first dose of the investigational therapy may be enrolled;",
                "criterions": [
                    {
                        "exact_snippets": "asymptomatic spinal cord compression indicated radiologically",
                        "criterion": "spinal cord compression",
                        "requirement": {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    },
                    {
                        "exact_snippets": "asymptomatic spinal cord compression indicated radiologically",
                        "criterion": "spinal cord compression",
                        "requirement": {
                            "requirement_type": "indication",
                            "expected_value": "radiologically"
                        }
                    },
                    {
                        "exact_snippets": "assessed as stable by the specialist",
                        "criterion": "spinal cord compression stability",
                        "requirement": {
                            "requirement_type": "assessment",
                            "expected_value": "stable"
                        }
                    },
                    {
                        "exact_snippets": "requiring no treatment presently",
                        "criterion": "spinal cord compression treatment",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": "no treatment presently"
                        }
                    },
                    {
                        "exact_snippets": "previously received treatment for CNS metastases",
                        "criterion": "CNS metastases treatment history",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "previously received"
                        }
                    },
                    {
                        "exact_snippets": "become stable for >=4 weeks as indicated radiologically",
                        "criterion": "CNS metastases stability",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "become stable for >=4 weeks as indicated radiologically",
                        "criterion": "CNS metastases stability",
                        "requirement": {
                            "requirement_type": "indication",
                            "expected_value": "radiologically"
                        }
                    },
                    {
                        "exact_snippets": "stopped systemic hormone therapy (prednisone in a dose >10 mg/d or an equivalent hormone) for >=4 weeks prior to the first dose of the investigational therapy",
                        "criterion": "systemic hormone therapy cessation",
                        "requirement": {
                            "requirement_type": "cessation",
                            "expected_value": "stopped"
                        }
                    },
                    {
                        "exact_snippets": "stopped systemic hormone therapy (prednisone in a dose >10 mg/d or an equivalent hormone) for >=4 weeks prior to the first dose of the investigational therapy",
                        "criterion": "systemic hormone therapy cessation",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "stopped systemic hormone therapy (prednisone in a dose >10 mg/d or an equivalent hormone) for >=4 weeks prior to the first dose of the investigational therapy",
                        "criterion": "systemic hormone therapy cessation",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/d"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ]
}