{
    "info": {
        "nct_id": "NCT05322720",
        "official_title": "A Phase II Clinical Study to Evaluate the Safety and Efficacy of Recombinant hLAG-3 Fusion Protein (EOC202) Injection Combined With Albumin-bound Paclitaxel in Treatment of the Patients With HR Positive, HER2 Negative Advanced Breast Cancer With Progression After Endocrine Therapy",
        "inclusion_criteria": "1. Understanding and voluntarily signing the informed consent form;\n2. Female, age ≥ 18 years and <65 years;\n3. Histopathologically and molecular pathologically confirmed HR positive, HER2 negative breast cancer (based on the latest test result);\n\n   Notes:\n\n   Positive HR is defined as positive estrogen receptor (ER), negative or positive progesterone receptor (PR) (≥1% positive stained cells will be regarded as positive receptor); Negative HER2: negative immunohistochemical (IHC) result (0, 1+), or IHC result 2+ and negative result of in situ hybridization (ISH) amplification;\n4. Progression after endocrine therapy, being suitable for late-stage rescue chemotherapy, including the following conditions (meeting any one of them):\n\n   Primary endocrine resistance: recurrence less than two years after adjuvant endocrine therapy, or progression of disease less than 6 months after late-stage 1st-line endocrine therapy. For the patients with primary endocrine resistance, no use of other systematic therapy except endocrine therapy in relapsed/progressive period (the combined use of CDK4/6 inhibitor, Everolimus or HDAC inhibitor with endocrine therapy is allowed). There were no more than 2 lines of systemic therapy for advanced disease previously.\n\n   Secondary (acquired) endocrine resistance: recurrence more than 2 years after adjuvant endocrine therapy and within one year after discontinuation of it, or progression of disease ≥6 months after late-stage 1st-line endocrine therapy. For the patients with secondary (acquired) endocrine resistance, at least 1 line but no more than 3 lines of endocrine therapy for advanced disease are recommended (the combined use of CDK4/6 inhibitor, Everolimus or HDAC inhibitor with endocrine therapy is allowed), and the number of lines will not be calculated for adjuvant endocrine therapy. There were no more than 3 lines of systemic therapy for advanced disease previously.\n5. No use of chemotherapy for recurrent/metastatic breast cancer;\n6. At least one extracranial measurable lesion (RECIST 1.1);\n7. Peripheral blood absolute monocyte count (AMC) <0.25×109/L (tested by local laboratory, it is allowed to be repeated once if the AMC is ranged from 0.25~0.35×109/L at screening);\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-1;\n9. Expected survival ≥3 months;\n10. Recovery of toxicity induced by previous therapy (except alopecia) to grade 1 (National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0 [NCI CTCAE v5.0]) or normal level;\n11. Good organ function within 1 week prior to the first dose of study drug:\n\n    Hematology: no transfusion of platelet or any growth factor within 7 days prior to the screening visit, white blood cell count ≥3×109/L, absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90 g/L; Hepatic function: serum total bilirubin ≤1.5× upper limit of normal (ULN), or total bilirubin ≤3×ULN in case of Gilbert's syndrome; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN, or AST and ALT≤5×ULN in case of hepatic metastasis; Renal function: serum creatinine ≤1.5×ULN.\n12. The female subjects of childbearing potential must have negative pregnancy test within 1 week prior to the first dose of study drug, and they and their spouses agree to take effective contraceptive measures during the study and within 6 months after the last dose\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "1. Known uncontrollable or symptomatic central nervous system metastasis, including brain metastasis or meningeal metastasis, or symptoms suggestive of cancerous meningitis, leptomeningeal disease and/or progressive growth. Patients with a history of central nervous system metastasis or spinal cord compression are allowed to be enrolled if they have received definite local treatment (e.g., radiotherapy, surgical therapy), have discontinued anticonvulsant drugs and steroids for at least 4 weeks prior to the first dose of study drug and have stable clinical manifestations;\n2. Previous use of high-dose chemotherapy plus hemopoietic stem cell transplantation;\n3. Grade 4 operation performed within 4 weeks prior to the first dose of study drug, or grade 2 or 3 operation performed within 7 days prior to the first dose of study drug;\n4. Abnormal thyroid function that is poorly controlled after treatment;\n5. Chemotherapy, endocrine therapy or treatment with other investigational product within 4 weeks or 5 half-lives prior to the first dose of study drug (whichever is longer); or radiotherapy within 2 weeks prior to the first dose of study drug (except the palliative radiotherapy for non-target lesion, enrollment will be allowed if the toxicity is resolved);\n6. Serious or uncontrolled heart disease (New York Heart Association [NYHA] grade III-IV) within 6 months prior to the first dose of study drug, including myocardial infarction, severe/unstable angina pectoris, ≥grade 2 persistent arrhythmia in accordance with NCI CTCAE v5.0, atrial fibrillation of any grade, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure; or presence of cerebrovascular accident, including transient ischemic attack, symptomatic pulmonary embolism, etc.;\n7. Presence of other malignant tumors within 5 years prior to the first dose of study drug (except for basal cell or squamous cell carcinoma of skin, superficial bladder cancer and carcinoma in situ of cervix, which have been cured);\n8. Other concomitant disease seriously hazardous to patient's safety or affecting completion of the study as judged by investigators, except for tumor;\n9. Presence of one of the following conditions: active infection considered by investigators that may affect patient's participation in the study or the study results; positive hepatitis B surface antigen, and hepatitis B virus (HBV) DNA copy > ULN (patients with HBV DNA copy reduced to normal range after antiviral therapy are allowed to be enrolled); positive hepatitis C virus antibody and hepatitis C virus (HCV) RNA copy >ULN; positive human immunodeficiency virus (HIV); or any serious infection requiring systematic treatment within 4 weeks prior to the first dose of study drug;\n10. Clinically significant abnormality indicated on electrocardiography (ECG), including but not limited to serious arrhythmia, prolonged QT interval (QTcF>470 ms, QTcF=QT/RR0.33); or presence of various conditions that may increase the risk of prolonged QT interval, e.g., known history of prolonged QTc, congenital long QT syndrome, Brugada syndrome, torsade de pointes, uncontrollable electrolyte disorder (e.g., calcemia, hypokalaemia and hypomagnesaemia, etc.);\n11. Previous diagnosis of autoimmune disease or requiring long-term use of systemic corticosteroids (dose >10 mg/day prednisone or equivalent) or other immunosuppressants within 4 weeks prior to the first dose of study drug; however, patients are allowed to be enrolled in the following conditions: in the absence of active autoimmune disease, inhaled or topical steroids, or adrenaline replacement therapy at the dose ≤10 mg/day Prednisone equivalent is allowed to be used;\n12. Treatment with systematic immunostimulatory drugs (including but not limited to interferon-α (IFN-α) and interleukin 2 (IL-2)) within 6 weeks or 5 half-lives prior to the first dose of study drug (whichever comes later);\n13. Vaccination with live attenuated vaccine, protein vaccine, mRNA or DNA vaccine within 4 weeks prior to the first dose of study drug, or expected to receive the above vaccines during the study;\n14. Previous allergy to macromolecular protein preparation or protein, or Quincke's edema (also known as angioneurotic edema), or known allergy to any component of the study drug;\n15. History of clear mental disorder, or history of psychotropic drug abuse, drug addiction or alcohol abuse;\n16. Received organ transplant;\n17. Women who are pregnant or breastfeeding;\n18. Having participated in any other drug clinical trial within 4 weeks prior to the first dose of study drug or currently receiving treatment in other clinical trials (except those who are participating in the follow-up of overall survival in one study);\n19. Patients with other conditions that are not suitable to participate in the clinical trial, as considered by the investigator.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Understanding and voluntarily signing the informed consent form;",
            "criterions": [
                {
                    "exact_snippets": "Understanding and voluntarily signing the informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "voluntary signing",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Female, age ≥ 18 years and <65 years;",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "age ≥ 18 years and <65 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 65,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Histopathologically and molecular pathologically confirmed HR positive, HER2 negative breast cancer (based on the latest test result);",
            "criterions": [
                {
                    "exact_snippets": "Histopathologically and molecular pathologically confirmed HR positive",
                    "criterion": "HR status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 negative breast cancer",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Positive HR is defined as positive estrogen receptor (ER), negative or positive progesterone receptor (PR) (≥1% positive stained cells will be regarded as positive receptor); Negative HER2: negative immunohistochemical (IHC) result (0, 1+), or IHC result 2+ and negative result of in situ hybridization (ISH) amplification;",
            "criterions": [
                {
                    "exact_snippets": "positive estrogen receptor (ER)",
                    "criterion": "estrogen receptor (ER)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative or positive progesterone receptor (PR) (≥1% positive stained cells will be regarded as positive receptor)",
                    "criterion": "progesterone receptor (PR)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "negative",
                                "positive"
                            ]
                        },
                        {
                            "requirement_type": "positive stained cells",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "interpretation",
                            "expected_value": "positive receptor"
                        }
                    ]
                },
                {
                    "exact_snippets": "Negative HER2: negative immunohistochemical (IHC) result (0, 1+)",
                    "criterion": "HER2",
                    "requirements": [
                        {
                            "requirement_type": "IHC result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "IHC score",
                            "expected_value": [
                                "0",
                                "1+"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Negative HER2: ... IHC result 2+ and negative result of in situ hybridization (ISH) amplification",
                    "criterion": "HER2",
                    "requirements": [
                        {
                            "requirement_type": "IHC result",
                            "expected_value": "2+"
                        },
                        {
                            "requirement_type": "ISH amplification",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Progression after endocrine therapy, being suitable for late-stage rescue chemotherapy, including the following conditions (meeting any one of them):",
            "criterions": [
                {
                    "exact_snippets": "Progression after endocrine therapy",
                    "criterion": "progression after endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "being suitable for late-stage rescue chemotherapy",
                    "criterion": "suitability for late-stage rescue chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Primary endocrine resistance: recurrence less than two years after adjuvant endocrine therapy, or progression of disease less than 6 months after late-stage 1st-line endocrine therapy. For the patients with primary endocrine resistance, no use of other systematic therapy except endocrine therapy in relapsed/progressive period (the combined use of CDK4/6 inhibitor, Everolimus or HDAC inhibitor with endocrine therapy is allowed). There were no more than 2 lines of systemic therapy for advanced disease previously.",
            "criterions": [
                {
                    "exact_snippets": "Primary endocrine resistance: recurrence less than two years after adjuvant endocrine therapy",
                    "criterion": "primary endocrine resistance",
                    "requirements": [
                        {
                            "requirement_type": "recurrence time",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Primary endocrine resistance: ... progression of disease less than 6 months after late-stage 1st-line endocrine therapy",
                    "criterion": "primary endocrine resistance",
                    "requirements": [
                        {
                            "requirement_type": "progression time",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no use of other systematic therapy except endocrine therapy in relapsed/progressive period",
                    "criterion": "systematic therapy use in relapsed/progressive period",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "the combined use of CDK4/6 inhibitor, Everolimus or HDAC inhibitor with endocrine therapy is allowed",
                    "criterion": "combined use of CDK4/6 inhibitor, Everolimus or HDAC inhibitor with endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "There were no more than 2 lines of systemic therapy for advanced disease previously",
                    "criterion": "lines of systemic therapy for advanced disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Secondary (acquired) endocrine resistance: recurrence more than 2 years after adjuvant endocrine therapy and within one year after discontinuation of it, or progression of disease ≥6 months after late-stage 1st-line endocrine therapy. For the patients with secondary (acquired) endocrine resistance, at least 1 line but no more than 3 lines of endocrine therapy for advanced disease are recommended (the combined use of CDK4/6 inhibitor, Everolimus or HDAC inhibitor with endocrine therapy is allowed), and the number of lines will not be calculated for adjuvant endocrine therapy. There were no more than 3 lines of systemic therapy for advanced disease previously.",
            "criterions": [
                {
                    "exact_snippets": "recurrence more than 2 years after adjuvant endocrine therapy",
                    "criterion": "recurrence after adjuvant endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since therapy",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrence ... within one year after discontinuation of it",
                    "criterion": "recurrence after discontinuation of adjuvant endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since discontinuation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "progression of disease ≥6 months after late-stage 1st-line endocrine therapy",
                    "criterion": "progression of disease after late-stage 1st-line endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 1 line but no more than 3 lines of endocrine therapy for advanced disease are recommended",
                    "criterion": "lines of endocrine therapy for advanced disease",
                    "requirements": [
                        {
                            "requirement_type": "number of lines",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "lines"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "lines"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no more than 3 lines of systemic therapy for advanced disease previously",
                    "criterion": "lines of systemic therapy for advanced disease",
                    "requirements": [
                        {
                            "requirement_type": "number of lines",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. No use of chemotherapy for recurrent/metastatic breast cancer;",
            "criterions": [
                {
                    "exact_snippets": "No use of chemotherapy for recurrent/metastatic breast cancer",
                    "criterion": "chemotherapy use for recurrent/metastatic breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. At least one extracranial measurable lesion (RECIST 1.1);",
            "criterions": [
                {
                    "exact_snippets": "At least one extracranial measurable lesion (RECIST 1.1)",
                    "criterion": "extracranial measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "measurement criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Peripheral blood absolute monocyte count (AMC) <0.25×109/L (tested by local laboratory, it is allowed to be repeated once if the AMC is ranged from 0.25~0.35×109/L at screening);",
            "criterions": [
                {
                    "exact_snippets": "Peripheral blood absolute monocyte count (AMC) <0.25×109/L",
                    "criterion": "peripheral blood absolute monocyte count (AMC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.25,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AMC is ranged from 0.25~0.35×109/L at screening",
                    "criterion": "peripheral blood absolute monocyte count (AMC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0.25,
                                        "unit": "×10^9/L"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 0.35,
                                        "unit": "×10^9/L"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-1;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-1",
                    "criterion": "ECOG Performance Status score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Expected survival ≥3 months;",
            "criterions": [
                {
                    "exact_snippets": "Expected survival ≥3 months",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Recovery of toxicity induced by previous therapy (except alopecia) to grade 1 (National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0 [NCI CTCAE v5.0]) or normal level;",
            "criterions": [
                {
                    "exact_snippets": "Recovery of toxicity induced by previous therapy (except alopecia) to grade 1 (National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0 [NCI CTCAE v5.0]) or normal level",
                    "criterion": "toxicity recovery",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "grade 1 or normal level"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Good organ function within 1 week prior to the first dose of study drug:",
            "criterions": [
                {
                    "exact_snippets": "Good organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematology: no transfusion of platelet or any growth factor within 7 days prior to the screening visit, white blood cell count ≥3×109/L, absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90 g/L; Hepatic function: serum total bilirubin ≤1.5× upper limit of normal (ULN), or total bilirubin ≤3×ULN in case of Gilbert's syndrome; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN, or AST and ALT≤5×ULN in case of hepatic metastasis; Renal function: serum creatinine ≤1.5×ULN.",
            "criterions": [
                {
                    "exact_snippets": "no transfusion of platelet or any growth factor within 7 days prior to the screening visit",
                    "criterion": "transfusion history",
                    "requirements": [
                        {
                            "requirement_type": "time since last transfusion",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 7,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "white blood cell count ≥3×109/L",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absolute neutrophil count (ANC) ≥1.5×109/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count ≥100×109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin ≥90 g/L",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum total bilirubin ≤1.5× upper limit of normal (ULN), or total bilirubin ≤3×ULN in case of Gilbert's syndrome",
                    "criterion": "serum total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "×ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "quantity in case of Gilbert's syndrome",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "×ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN, or AST and ALT≤5×ULN in case of hepatic metastasis",
                    "criterion": "aspartate aminotransferase (AST) and alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "×ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "quantity in case of hepatic metastasis",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "×ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine ≤1.5×ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "×ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. The female subjects of childbearing potential must have negative pregnancy test within 1 week prior to the first dose of study drug, and they and their spouses agree to take effective contraceptive measures during the study and within 6 months after the last dose",
            "criterions": [
                {
                    "exact_snippets": "female subjects of childbearing potential",
                    "criterion": "female subjects of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "pregnancy test result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "they and their spouses agree to take effective contraceptive measures during the study and within 6 months after the last dose",
                    "criterion": "contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study and within 6 months after the last dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Known uncontrollable or symptomatic central nervous system metastasis, including brain metastasis or meningeal metastasis, or symptoms suggestive of cancerous meningitis, leptomeningeal disease and/or progressive growth. Patients with a history of central nervous system metastasis or spinal cord compression are allowed to be enrolled if they have received definite local treatment (e.g., radiotherapy, surgical therapy), have discontinued anticonvulsant drugs and steroids for at least 4 weeks prior to the first dose of study drug and have stable clinical manifestations;",
            "criterions": [
                {
                    "exact_snippets": "Known uncontrollable or symptomatic central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "symptomatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "meningeal metastasis",
                    "criterion": "meningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "symptoms suggestive of cancerous meningitis",
                    "criterion": "cancerous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "suggestive"
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progressive growth",
                    "criterion": "progressive growth",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "progressive"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of central nervous system metastasis",
                    "criterion": "history of central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "received definite local treatment (e.g., radiotherapy, surgical therapy)",
                    "criterion": "definite local treatment",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "discontinued anticonvulsant drugs and steroids for at least 4 weeks prior to the first dose of study drug",
                    "criterion": "discontinuation of anticonvulsant drugs and steroids",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stable clinical manifestations",
                    "criterion": "clinical manifestations",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Grade 4 operation performed within 4 weeks prior to the first dose of study drug, or grade 2 or 3 operation performed within 7 days prior to the first dose of study drug;",
            "criterions": [
                {
                    "exact_snippets": "Grade 4 operation performed within 4 weeks prior to the first dose of study drug",
                    "criterion": "grade 4 operation",
                    "requirements": [
                        {
                            "requirement_type": "time since operation",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "grade 2 or 3 operation performed within 7 days prior to the first dose of study drug",
                    "criterion": "grade 2 or 3 operation",
                    "requirements": [
                        {
                            "requirement_type": "time since operation",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 7,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Abnormal thyroid function that is poorly controlled after treatment;",
            "criterions": [
                {
                    "exact_snippets": "Abnormal thyroid function",
                    "criterion": "thyroid function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "abnormal"
                        }
                    ]
                },
                {
                    "exact_snippets": "poorly controlled after treatment",
                    "criterion": "thyroid function control",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Chemotherapy, endocrine therapy or treatment with other investigational product within 4 weeks or 5 half-lives prior to the first dose of study drug (whichever is longer); or radiotherapy within 2 weeks prior to the first dose of study drug (except the palliative radiotherapy for non-target lesion, enrollment will be allowed if the toxicity is resolved);",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy, endocrine therapy or treatment with other investigational product within 4 weeks or 5 half-lives prior to the first dose of study drug (whichever is longer)",
                    "criterion": "prior chemotherapy, endocrine therapy, or investigational product treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy within 2 weeks prior to the first dose of study drug (except the palliative radiotherapy for non-target lesion, enrollment will be allowed if the toxicity is resolved)",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "exception",
                            "expected_value": "palliative radiotherapy for non-target lesion with resolved toxicity"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Serious or uncontrolled heart disease (New York Heart Association [NYHA] grade III-IV) within 6 months prior to the first dose of study drug, including myocardial infarction, severe/unstable angina pectoris, ≥grade 2 persistent arrhythmia in accordance with NCI CTCAE v5.0, atrial fibrillation of any grade, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure; or presence of cerebrovascular accident, including transient ischemic attack, symptomatic pulmonary embolism, etc.;",
            "criterions": [
                {
                    "exact_snippets": "Serious or uncontrolled heart disease (New York Heart Association [NYHA] grade III-IV)",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "serious",
                                "uncontrolled"
                            ]
                        },
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "NYHA"
                            }
                        },
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "=",
                                "value": 4,
                                "unit": "NYHA"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe/unstable angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "severe",
                                "unstable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "≥grade 2 persistent arrhythmia in accordance with NCI CTCAE v5.0",
                    "criterion": "persistent arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NCI CTCAE v5.0"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "atrial fibrillation of any grade",
                    "criterion": "atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "coronary/peripheral artery bypass grafting",
                    "criterion": "coronary/peripheral artery bypass grafting",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of cerebrovascular accident, including transient ischemic attack",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Presence of other malignant tumors within 5 years prior to the first dose of study drug (except for basal cell or squamous cell carcinoma of skin, superficial bladder cancer and carcinoma in situ of cervix, which have been cured);",
            "criterions": [
                {
                    "exact_snippets": "Presence of other malignant tumors within 5 years prior to the first dose of study drug",
                    "criterion": "other malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 5 years prior to the first dose of study drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for basal cell or squamous cell carcinoma of skin",
                    "criterion": "basal cell or squamous cell carcinoma of skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "superficial bladder cancer",
                    "criterion": "superficial bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoma in situ of cervix, which have been cured",
                    "criterion": "carcinoma in situ of cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "cure status",
                            "expected_value": "cured"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Other concomitant disease seriously hazardous to patient's safety or affecting completion of the study as judged by investigators, except for tumor;",
            "criterions": [
                {
                    "exact_snippets": "Other concomitant disease seriously hazardous to patient's safety",
                    "criterion": "concomitant disease",
                    "requirements": [
                        {
                            "requirement_type": "hazardousness",
                            "expected_value": "seriously hazardous to patient's safety"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other concomitant disease ... affecting completion of the study",
                    "criterion": "concomitant disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on study completion",
                            "expected_value": "affecting completion of the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Presence of one of the following conditions: active infection considered by investigators that may affect patient's participation in the study or the study results; positive hepatitis B surface antigen, and hepatitis B virus (HBV) DNA copy > ULN (patients with HBV DNA copy reduced to normal range after antiviral therapy are allowed to be enrolled); positive hepatitis C virus antibody and hepatitis C virus (HCV) RNA copy >ULN; positive human immunodeficiency virus (HIV); or any serious infection requiring systematic treatment within 4 weeks prior to the first dose of study drug;",
            "criterions": [
                {
                    "exact_snippets": "active infection considered by investigators that may affect patient's participation in the study or the study results",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive hepatitis B surface antigen",
                    "criterion": "hepatitis B surface antigen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B virus (HBV) DNA copy > ULN",
                    "criterion": "hepatitis B virus (HBV) DNA copy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "positive hepatitis C virus antibody",
                    "criterion": "hepatitis C virus antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C virus (HCV) RNA copy >ULN",
                    "criterion": "hepatitis C virus (HCV) RNA copy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "positive human immunodeficiency virus (HIV)",
                    "criterion": "human immunodeficiency virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any serious infection requiring systematic treatment within 4 weeks prior to the first dose of study drug",
                    "criterion": "serious infection requiring systematic treatment",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to the first dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Clinically significant abnormality indicated on electrocardiography (ECG), including but not limited to serious arrhythmia, prolonged QT interval (QTcF>470 ms, QTcF=QT/RR0.33); or presence of various conditions that may increase the risk of prolonged QT interval, e.g., known history of prolonged QTc, congenital long QT syndrome, Brugada syndrome, torsade de pointes, uncontrollable electrolyte disorder (e.g., calcemia, hypokalaemia and hypomagnesaemia, etc.);",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant abnormality indicated on electrocardiography (ECG)",
                    "criterion": "ECG abnormality",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "prolonged QT interval (QTcF>470 ms, QTcF=QT/RR0.33)",
                    "criterion": "QT interval",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "known history of prolonged QTc",
                    "criterion": "history of prolonged QTc",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Brugada syndrome",
                    "criterion": "Brugada syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "torsade de pointes",
                    "criterion": "torsade de pointes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable electrolyte disorder (e.g., calcemia, hypokalaemia and hypomagnesaemia, etc.)",
                    "criterion": "electrolyte disorder",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Previous diagnosis of autoimmune disease or requiring long-term use of systemic corticosteroids (dose >10 mg/day prednisone or equivalent) or other immunosuppressants within 4 weeks prior to the first dose of study drug; however, patients are allowed to be enrolled in the following conditions: in the absence of active autoimmune disease, inhaled or topical steroids, or adrenaline replacement therapy at the dose ≤10 mg/day Prednisone equivalent is allowed to be used;",
            "criterions": [
                {
                    "exact_snippets": "Previous diagnosis of autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring long-term use of systemic corticosteroids (dose >10 mg/day prednisone or equivalent)",
                    "criterion": "systemic corticosteroids use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "long-term"
                        },
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/day prednisone or equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other immunosuppressants within 4 weeks prior to the first dose of study drug",
                    "criterion": "immunosuppressants use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to the first dose of study drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "inhaled or topical steroids",
                    "criterion": "inhaled or topical steroids",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adrenaline replacement therapy at the dose ≤10 mg/day Prednisone equivalent",
                    "criterion": "adrenaline replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg/day Prednisone equivalent"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Treatment with systematic immunostimulatory drugs (including but not limited to interferon-α (IFN-α) and interleukin 2 (IL-2)) within 6 weeks or 5 half-lives prior to the first dose of study drug (whichever comes later);",
            "criterions": [
                {
                    "exact_snippets": "Treatment with systematic immunostimulatory drugs (including but not limited to interferon-α (IFN-α) and interleukin 2 (IL-2)) within 6 weeks or 5 half-lives prior to the first dose of study drug",
                    "criterion": "treatment with systematic immunostimulatory drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 6,
                                        "unit": "weeks"
                                    },
                                    {
                                        "operator": ">",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Vaccination with live attenuated vaccine, protein vaccine, mRNA or DNA vaccine within 4 weeks prior to the first dose of study drug, or expected to receive the above vaccines during the study;",
            "criterions": [
                {
                    "exact_snippets": "Vaccination with live attenuated vaccine, protein vaccine, mRNA or DNA vaccine within 4 weeks prior to the first dose of study drug",
                    "criterion": "vaccination",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "live attenuated vaccine",
                                "protein vaccine",
                                "mRNA",
                                "DNA vaccine"
                            ]
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "expected to receive the above vaccines during the study",
                    "criterion": "vaccination",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "live attenuated vaccine",
                                "protein vaccine",
                                "mRNA",
                                "DNA vaccine"
                            ]
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "during the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Previous allergy to macromolecular protein preparation or protein, or Quincke's edema (also known as angioneurotic edema), or known allergy to any component of the study drug;",
            "criterions": [
                {
                    "exact_snippets": "Previous allergy to macromolecular protein preparation or protein",
                    "criterion": "allergy to macromolecular protein preparation or protein",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Quincke's edema (also known as angioneurotic edema)",
                    "criterion": "Quincke's edema",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known allergy to any component of the study drug",
                    "criterion": "allergy to any component of the study drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. History of clear mental disorder, or history of psychotropic drug abuse, drug addiction or alcohol abuse;",
            "criterions": [
                {
                    "exact_snippets": "History of clear mental disorder",
                    "criterion": "mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of psychotropic drug abuse",
                    "criterion": "psychotropic drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... drug addiction",
                    "criterion": "drug addiction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... alcohol abuse",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Received organ transplant;",
            "criterions": [
                {
                    "exact_snippets": "Received organ transplant",
                    "criterion": "organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Women who are pregnant or breastfeeding;",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Having participated in any other drug clinical trial within 4 weeks prior to the first dose of study drug or currently receiving treatment in other clinical trials (except those who are participating in the follow-up of overall survival in one study);",
            "criterions": [
                {
                    "exact_snippets": "Having participated in any other drug clinical trial within 4 weeks prior to the first dose of study drug",
                    "criterion": "participation in other drug clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "currently receiving treatment in other clinical trials",
                    "criterion": "current treatment in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Patients with other conditions that are not suitable to participate in the clinical trial, as considered by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "other conditions that are not suitable to participate in the clinical trial",
                    "criterion": "other conditions",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": "not suitable to participate in the clinical trial"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Notes:",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "2. Previous use of high-dose chemotherapy plus hemopoietic stem cell transplantation;",
            "criterions": [
                {
                    "exact_snippets": "Previous use of high-dose chemotherapy",
                    "criterion": "high-dose chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "previous use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previous use of ... hemopoietic stem cell transplantation",
                    "criterion": "hemopoietic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "previous use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}