{
    "info": {
        "nct_id": "NCT04750382",
        "official_title": "A Single-armed Multicenter Phase Ib / II Study of HX008 (a Recombinant Humanized Anti-PD-1 Monoclonal Antibody) Combined With GP Regimen as the First-line Treatment in Patients With Metastatic Triple Negative Breast Cancer",
        "inclusion_criteria": "* Provide written informed consent voluntarily. Understand this protocol and be willing and able to adhere to the study visit schedule.\n* Age 18-70 years old, male or female.\n* Diagnosed with stage IV or recurrent or metastatic TNBC who are not suitable for surgical treatment.\n* Histopathology shows that ER, PR and HER-2 are all negative. If metastasis exists, the histopathology result of metastasis is preferred. ER and PR negative are defined as ER < 1% and PR < 1%. HER-2 negative is defined as HER-2 (-) or (+) in immunohistochemical test. For HER-2 (++), additional negative result should be observed in FISH test. For HER-2 (-) or (+), FISH test is optional, but the result should be negative.\n* Have not been treated with any chemotherapy drugs for recurrent and metastatic triple negative breast cancer (adjuvant / neoadjuvant therapy is allowed, if the time between the last dose of drug and recurrence or metastasis is more than 6 months).\n* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.\n* Life expectancy ≥ 3 months.\n* Has at least one measurable extracranial lesion according to RECIST1.1, which has not been treated with radiotherapy.\n* Has sufficient organ and bone marrow function to meet the following laboratory examination standards:\n\n  1. Blood routine: absolute neutrophil count (ANC)≥1.5×10^9/L; while blood cell count (WBC)≥3×10^9/L; platelet count (PLT)≥100×10^9/ L; hemoglobin (HGB)≥90 g/L (without blood transfusion within 14 days prior to enrollment);\n  2. Renal function: serum creatinine (Scr) ≤1.5×ULN, and endogenous creatinine clearance is more than 50 ml / min (Cockcroft Gault formula);\n  3. Liver function: TBIL≤1.5×ULN; Patients without liver metastases require alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN. Patients with liver metastases require: ALT and AST≤5×ULN;\n  4. The coagulation function is adequate, which is defined as the international normalized ratio (INR) ≤ 2×ULN; or activated partial thromboplastin time (APTT)≤ 1.5×ULN (except for those who are receiving anticoagulant therapy if their PT/APTT are within the expected values);\n* Reproductive men and women of childbearing age are willing to take effective contraceptive measures (such as oral contraceptives, intrauterine contraceptives, sexual abstinence or barrier contraceptives combined with spermicide) from signing the informed consent form to 12 months after the last administration of the trial drug.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Suffered from other malignant tumors in the past 5 years, except carcinoma in situ from cervix or skin basal cell carcinoma that has been cured.\n* With adverse reactions of previous treatment that have not be recovered to CTCAE V5.0 grade ≤ 1, except for the residual hair loss effect.\n* Had prior treatment with any anti-PD-1, PD-L1 or CTLA-4 therapies.\n* Participants with active or a history of autoimmune diseases that probably will recur (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, etc.), or with high risk (e.g. organ transplantation requiring immunosuppressive therapy). However, participants with the following diseases are eligible: skin diseases requiring no systemic treatment (such as eczema, skin rash covering less than 10% of the body surface, psoriasis without ophthalmic symptoms, etc.).\n* Expected to undergo major surgery during the study treatment or within 28 days before the first administration of the study drug (excluding surgery for diagnostic purpose).\n* Need to receive systemic corticosteroids (dose equivalent to > 10 mg prednisone / day) or other immunosuppressive drugs within 14 days before enrollment or during the study period. Those under the following conditions are eligible: a) Locally external use or inhaled corticosteroids; b) short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases.\n* Has active digestive ulcer, incomplete intestinal obstruction, active gastrointestinal hemorrhage or perforation.\n* Has active interstitial pneumonia, pulmonary fibrosis, acute pulmonary disorders, acute radiation pneumonitis, et al.\n* Has uncontrolled systemic diseases, such as cardiovascular and cerebrovascular diseases (unstable angina pectoris, etc.), diabetes, hypertension, tuberculosis, etc;\n* Has a history of HIV infection, or other acquired or innate immune deficiency disorders, or a history of organ or stem-cell transplantation.\n* Has active chronic HBV or HCV infection, except those with HBV DNA viral load ≤500 IU/mL or <10^3 copies/mL, or HCV RNA negative after adequate treatment.\n* Has severe infection within 4 weeks or active infection requiring IV infusion or oral administration of antibiotics within 2 weeks prior to the first dose of the study drug.\n* Known to be allergic to macromolecular protein agents or monoclonal antibody; Known to has a history of severe allergies (CTCAE v5.0 ≥ grade 3) to any of the components in the study drug.\n* Has participated in other clinical trial within 4 weeks before the first administration of the study drug.\n* Alcohol dependence or drug abuse within recent one year.\n* Has a history of confirmed neurological or mental disorders, such as epilepsy, dementia; or with poor compliance; or the presence of peripheral neurological disorders.\n* Has symptomatic central nervous system metastasis.\n* Participants with asymptomatic central nervous system metastasis with or without treatment, who have no disease progression by CT / MRI examination, and whose interval from the last radiotherapy is more than 4 weeks, can be enrolled.\n* Participants with uncontrollable pleural effusion, peritoneal effusion or pericardial effusion requiring repeated drainage within 7 days before enrollment.\n* Participants who had received hematopoietic stimulating factors such as colony stimulating factor and erythropoietin within 2 weeks prior to the first dose of study drug\n* Is pregnant or breastfeeding.\n* Other reasons disqualifying the entering of this study based on the evaluation of the investigators.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Provide written informed consent voluntarily. Understand this protocol and be willing and able to adhere to the study visit schedule.",
                "criterions": [
                    {
                        "exact_snippets": "Provide written informed consent voluntarily",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Understand this protocol",
                        "criterion": "protocol understanding",
                        "requirement": {
                            "requirement_type": "comprehension",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "be willing and able to adhere to the study visit schedule",
                        "criterion": "adherence to study visit schedule",
                        "requirement": {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Provide written informed consent voluntarily",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Understand this protocol",
                        "criterion": "protocol understanding",
                        "requirement": {
                            "requirement_type": "comprehension",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "be willing and able to adhere to the study visit schedule",
                        "criterion": "adherence to study visit schedule",
                        "requirement": {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age 18-70 years old, male or female.",
                "criterions": [
                    {
                        "exact_snippets": "Age 18-70 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "male or female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age 18-70 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "male or female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have not been treated with any chemotherapy drugs for recurrent and metastatic triple negative breast cancer (adjuvant / neoadjuvant therapy is allowed, if the time between the last dose of drug and recurrence or metastasis is more than 6 months).",
                "criterions": [
                    {
                        "exact_snippets": "Have not been treated with any chemotherapy drugs for recurrent and metastatic triple negative breast cancer",
                        "criterion": "chemotherapy treatment for recurrent and metastatic triple negative breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "adjuvant / neoadjuvant therapy is allowed, if the time between the last dose of drug and recurrence or metastasis is more than 6 months",
                        "criterion": "adjuvant / neoadjuvant therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adjuvant / neoadjuvant therapy is allowed, if the time between the last dose of drug and recurrence or metastasis is more than 6 months",
                        "criterion": "adjuvant / neoadjuvant therapy",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Have not been treated with any chemotherapy drugs for recurrent and metastatic triple negative breast cancer",
                    "criterion": "chemotherapy treatment for recurrent and metastatic triple negative breast cancer",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "then_criteria": {
                    "or_criteria": [
                        {
                            "exact_snippets": "adjuvant / neoadjuvant therapy is allowed, if the time between the last dose of drug and recurrence or metastasis is more than 6 months",
                            "criterion": "adjuvant / neoadjuvant therapy",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "adjuvant / neoadjuvant therapy is allowed, if the time between the last dose of drug and recurrence or metastasis is more than 6 months",
                                    "criterion": "adjuvant / neoadjuvant therapy",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "adjuvant / neoadjuvant therapy is allowed, if the time between the last dose of drug and recurrence or metastasis is more than 6 months",
                                    "criterion": "adjuvant / neoadjuvant therapy",
                                    "requirement": {
                                        "requirement_type": "time since last dose",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": ">",
                                                    "value": 6,
                                                    "unit": "months"
                                                }
                                            ]
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy ≥ 3 months.",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy ≥ 3 months.",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy ≥ 3 months.",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has at least one measurable extracranial lesion according to RECIST1.1, which has not been treated with radiotherapy.",
                "criterions": [
                    {
                        "exact_snippets": "at least one measurable extracranial lesion",
                        "criterion": "extracranial lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least one measurable extracranial lesion",
                        "criterion": "extracranial lesion",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "not been treated with radiotherapy",
                        "criterion": "radiotherapy treatment",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "not treated"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "at least one measurable extracranial lesion",
                                "criterion": "extracranial lesion",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "at least one measurable extracranial lesion",
                                "criterion": "extracranial lesion",
                                "requirement": {
                                    "requirement_type": "measurability",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "not been treated with radiotherapy",
                        "criterion": "radiotherapy treatment",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "not treated"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has sufficient organ and bone marrow function to meet the following laboratory examination standards:",
                "criterions": [
                    {
                        "exact_snippets": "sufficient organ and bone marrow function",
                        "criterion": "organ and bone marrow function",
                        "requirement": {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "sufficient organ and bone marrow function",
                        "criterion": "organ and bone marrow function",
                        "requirement": {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Blood routine: absolute neutrophil count (ANC)≥1.5×10^9/L; while blood cell count (WBC)≥3×10^9/L; platelet count (PLT)≥100×10^9/ L; hemoglobin (HGB)≥90 g/L (without blood transfusion within 14 days prior to enrollment);",
                "criterions": [
                    {
                        "exact_snippets": "absolute neutrophil count (ANC)≥1.5×10^9/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "while blood cell count (WBC)≥3×10^9/L",
                        "criterion": "white blood cell count (WBC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "×10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelet count (PLT)≥100×10^9/ L",
                        "criterion": "platelet count (PLT)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hemoglobin (HGB)≥90 g/L (without blood transfusion within 14 days prior to enrollment)",
                        "criterion": "hemoglobin (HGB)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hemoglobin (HGB)≥90 g/L (without blood transfusion within 14 days prior to enrollment)",
                        "criterion": "hemoglobin (HGB)",
                        "requirement": {
                            "requirement_type": "blood transfusion",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "absolute neutrophil count (ANC)≥1.5×10^9/L",
                                "criterion": "absolute neutrophil count (ANC)",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1.5,
                                        "unit": "×10^9/L"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "while blood cell count (WBC)≥3×10^9/L",
                                "criterion": "white blood cell count (WBC)",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "×10^9/L"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "platelet count (PLT)≥100×10^9/ L",
                                "criterion": "platelet count (PLT)",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 100,
                                        "unit": "×10^9/L"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "hemoglobin (HGB)≥90 g/L (without blood transfusion within 14 days prior to enrollment)",
                                "criterion": "hemoglobin (HGB)",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 90,
                                        "unit": "g/L"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "hemoglobin (HGB)≥90 g/L (without blood transfusion within 14 days prior to enrollment)",
                                "criterion": "hemoglobin (HGB)",
                                "requirement": {
                                    "requirement_type": "blood transfusion",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Liver function: TBIL≤1.5×ULN; Patients without liver metastases require alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN. Patients with liver metastases require: ALT and AST≤5×ULN;",
                "criterions": [
                    {
                        "exact_snippets": "Liver function: TBIL≤1.5×ULN",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "TBIL level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients without liver metastases require alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "ALT level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients without liver metastases require alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "AST level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients with liver metastases require: ALT and AST≤5×ULN",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "ALT level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients with liver metastases require: ALT and AST≤5×ULN",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "AST level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Liver function: TBIL≤1.5×ULN",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "TBIL level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "condition": {
                            "not_criteria": {
                                "exact_snippets": "Patients with liver metastases require: ALT and AST≤5×ULN",
                                "criterion": "liver function",
                                "requirement": {
                                    "requirement_type": "ALT level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "ULN"
                                    }
                                }
                            }
                        },
                        "then_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Patients without liver metastases require alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN",
                                    "criterion": "liver function",
                                    "requirement": {
                                        "requirement_type": "ALT level",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 2.5,
                                            "unit": "ULN"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "Patients without liver metastases require alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN",
                                    "criterion": "liver function",
                                    "requirement": {
                                        "requirement_type": "AST level",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 2.5,
                                            "unit": "ULN"
                                        }
                                    }
                                }
                            ]
                        },
                        "else_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Patients with liver metastases require: ALT and AST≤5×ULN",
                                    "criterion": "liver function",
                                    "requirement": {
                                        "requirement_type": "ALT level",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 5,
                                            "unit": "ULN"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "Patients with liver metastases require: ALT and AST≤5×ULN",
                                    "criterion": "liver function",
                                    "requirement": {
                                        "requirement_type": "AST level",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 5,
                                            "unit": "ULN"
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. The coagulation function is adequate, which is defined as the international normalized ratio (INR) ≤ 2×ULN; or activated partial thromboplastin time (APTT)≤ 1.5×ULN (except for those who are receiving anticoagulant therapy if their PT/APTT are within the expected values);",
                "criterions": [
                    {
                        "exact_snippets": "The coagulation function is adequate, which is defined as the international normalized ratio (INR) ≤ 2×ULN",
                        "criterion": "international normalized ratio (INR)",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "×ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "activated partial thromboplastin time (APTT)≤ 1.5×ULN",
                        "criterion": "activated partial thromboplastin time (APTT)",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "×ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "except for those who are receiving anticoagulant therapy if their PT/APTT are within the expected values",
                        "criterion": "anticoagulant therapy",
                        "requirement": {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "or_criteria": [
                                {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "The coagulation function is adequate, which is defined as the international normalized ratio (INR) ≤ 2×ULN",
                                            "criterion": "international normalized ratio (INR)",
                                            "requirement": {
                                                "requirement_type": "adequacy",
                                                "expected_value": {
                                                    "operator": "<=",
                                                    "value": 2,
                                                    "unit": "×ULN"
                                                }
                                            }
                                        },
                                        {
                                            "exact_snippets": "activated partial thromboplastin time (APTT)≤ 1.5×ULN",
                                            "criterion": "activated partial thromboplastin time (APTT)",
                                            "requirement": {
                                                "requirement_type": "adequacy",
                                                "expected_value": {
                                                    "operator": "<=",
                                                    "value": 1.5,
                                                    "unit": "×ULN"
                                                }
                                            }
                                        }
                                    ]
                                },
                                {
                                    "exact_snippets": "except for those who are receiving anticoagulant therapy if their PT/APTT are within the expected values",
                                    "criterion": "anticoagulant therapy",
                                    "requirement": {
                                        "requirement_type": "receiving",
                                        "expected_value": true
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": {
                    "exact_snippets": "except for those who are receiving anticoagulant therapy if their PT/APTT are within the expected values",
                    "criterion": "anticoagulant therapy",
                    "requirement": {
                        "requirement_type": "receiving",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Reproductive men and women of childbearing age are willing to take effective contraceptive measures (such as oral contraceptives, intrauterine contraceptives, sexual abstinence or barrier contraceptives combined with spermicide) from signing the informed consent form to 12 months after the last administration of the trial drug.",
                "criterions": [
                    {
                        "exact_snippets": "Reproductive men and women of childbearing age",
                        "criterion": "reproductive status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing to take effective contraceptive measures",
                        "criterion": "willingness to use contraception",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "effective contraceptive measures (such as oral contraceptives, intrauterine contraceptives, sexual abstinence or barrier contraceptives combined with spermicide)",
                        "criterion": "contraceptive measures",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "oral contraceptives",
                                "intrauterine contraceptives",
                                "sexual abstinence",
                                "barrier contraceptives combined with spermicide"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "from signing the informed consent form to 12 months after the last administration of the trial drug",
                        "criterion": "duration of contraceptive use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "from signing the informed consent form to 12 months after the last administration of the trial drug"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Reproductive men and women of childbearing age",
                                "criterion": "reproductive status",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "willing to take effective contraceptive measures",
                                "criterion": "willingness to use contraception",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "effective contraceptive measures (such as oral contraceptives, intrauterine contraceptives, sexual abstinence or barrier contraceptives combined with spermicide)",
                        "criterion": "contraceptive measures",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "oral contraceptives",
                                "intrauterine contraceptives",
                                "sexual abstinence",
                                "barrier contraceptives combined with spermicide"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "from signing the informed consent form to 12 months after the last administration of the trial drug",
                        "criterion": "duration of contraceptive use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "from signing the informed consent form to 12 months after the last administration of the trial drug"
                        }
                    }
                ]
            }
        },
        {
            "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 70 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Suffered from other malignant tumors in the past 5 years, except carcinoma in situ from cervix or skin basal cell carcinoma that has been cured.",
                "criterions": [
                    {
                        "exact_snippets": "Suffered from other malignant tumors in the past 5 years",
                        "criterion": "history of malignant tumors",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "except carcinoma in situ from cervix",
                        "criterion": "carcinoma in situ from cervix",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    },
                    {
                        "exact_snippets": "except ... skin basal cell carcinoma that has been cured",
                        "criterion": "skin basal cell carcinoma",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Suffered from other malignant tumors in the past 5 years",
                                    "criterion": "history of malignant tumors",
                                    "requirement": {
                                        "requirement_type": "time frame",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 5,
                                            "unit": "years"
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "or_criteria": [
                                            {
                                                "exact_snippets": "except carcinoma in situ from cervix",
                                                "criterion": "carcinoma in situ from cervix",
                                                "requirement": {
                                                    "requirement_type": "status",
                                                    "expected_value": "cured"
                                                }
                                            },
                                            {
                                                "exact_snippets": "except ... skin basal cell carcinoma that has been cured",
                                                "criterion": "skin basal cell carcinoma",
                                                "requirement": {
                                                    "requirement_type": "status",
                                                    "expected_value": "cured"
                                                }
                                            }
                                        ]
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* With adverse reactions of previous treatment that have not be recovered to CTCAE V5.0 grade ≤ 1, except for the residual hair loss effect.",
                "criterions": [
                    {
                        "exact_snippets": "adverse reactions of previous treatment that have not be recovered to CTCAE V5.0 grade ≤ 1",
                        "criterion": "adverse reactions of previous treatment",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE V5.0 grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "residual hair loss effect",
                        "criterion": "residual hair loss effect",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "adverse reactions of previous treatment that have not be recovered to CTCAE V5.0 grade ≤ 1",
                                    "criterion": "adverse reactions of previous treatment",
                                    "requirement": {
                                        "requirement_type": "severity",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 1,
                                            "unit": "CTCAE V5.0 grade"
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "residual hair loss effect",
                                        "criterion": "residual hair loss effect",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Had prior treatment with any anti-PD-1, PD-L1 or CTLA-4 therapies.",
                "criterions": [
                    {
                        "exact_snippets": "prior treatment with any anti-PD-1",
                        "criterion": "prior treatment with anti-PD-1 therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior treatment with any ... PD-L1",
                        "criterion": "prior treatment with PD-L1 therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior treatment with any ... CTLA-4 therapies",
                        "criterion": "prior treatment with CTLA-4 therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "prior treatment with any anti-PD-1",
                        "criterion": "prior treatment with anti-PD-1 therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior treatment with any ... PD-L1",
                        "criterion": "prior treatment with PD-L1 therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior treatment with any ... CTLA-4 therapies",
                        "criterion": "prior treatment with CTLA-4 therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants with active or a history of autoimmune diseases that probably will recur (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, etc.), or with high risk (e.g. organ transplantation requiring immunosuppressive therapy). However, participants with the following diseases are eligible: skin diseases requiring no systemic treatment (such as eczema, skin rash covering less than 10% of the body surface, psoriasis without ophthalmic symptoms, etc.).",
                "criterions": [
                    {
                        "exact_snippets": "Participants with active or a history of autoimmune diseases",
                        "criterion": "autoimmune diseases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "autoimmune diseases that probably will recur",
                        "criterion": "autoimmune diseases",
                        "requirement": {
                            "requirement_type": "recurrence risk",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "high risk (e.g. organ transplantation requiring immunosuppressive therapy)",
                        "criterion": "high risk of recurrence",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "participants with the following diseases are eligible: skin diseases requiring no systemic treatment",
                        "criterion": "skin diseases requiring no systemic treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Participants with active or a history of autoimmune diseases",
                                                "criterion": "autoimmune diseases",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            },
                                            {
                                                "exact_snippets": "autoimmune diseases that probably will recur",
                                                "criterion": "autoimmune diseases",
                                                "requirement": {
                                                    "requirement_type": "recurrence risk",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "high risk (e.g. organ transplantation requiring immunosuppressive therapy)",
                                        "criterion": "high risk of recurrence",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "participants with the following diseases are eligible: skin diseases requiring no systemic treatment",
                                "criterion": "skin diseases requiring no systemic treatment",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Expected to undergo major surgery during the study treatment or within 28 days before the first administration of the study drug (excluding surgery for diagnostic purpose).",
                "criterions": [
                    {
                        "exact_snippets": "Expected to undergo major surgery during the study treatment or within 28 days before the first administration of the study drug",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "during the study treatment or within 28 days before the first administration of the study drug"
                        }
                    },
                    {
                        "exact_snippets": "excluding surgery for diagnostic purpose",
                        "criterion": "surgery for diagnostic purpose",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Expected to undergo major surgery during the study treatment or within 28 days before the first administration of the study drug",
                                "criterion": "major surgery",
                                "requirement": {
                                    "requirement_type": "timing",
                                    "expected_value": "during the study treatment or within 28 days before the first administration of the study drug"
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "excluding surgery for diagnostic purpose",
                                    "criterion": "surgery for diagnostic purpose",
                                    "requirement": {
                                        "requirement_type": "exclusion",
                                        "expected_value": true
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Need to receive systemic corticosteroids (dose equivalent to > 10 mg prednisone / day) or other immunosuppressive drugs within 14 days before enrollment or during the study period. Those under the following conditions are eligible: a) Locally external use or inhaled corticosteroids; b) short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases.",
                "criterions": [
                    {
                        "exact_snippets": "Need to receive systemic corticosteroids (dose equivalent to > 10 mg prednisone / day)",
                        "criterion": "systemic corticosteroids",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg prednisone / day"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Need to receive ... other immunosuppressive drugs within 14 days before enrollment or during the study period",
                        "criterion": "immunosuppressive drugs",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 14 days before enrollment or during the study period"
                        }
                    },
                    {
                        "exact_snippets": "Locally external use or inhaled corticosteroids",
                        "criterion": "corticosteroids",
                        "requirement": {
                            "requirement_type": "route of administration",
                            "expected_value": [
                                "locally external use",
                                "inhaled"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases",
                        "criterion": "glucocorticoids",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases",
                        "criterion": "glucocorticoids",
                        "requirement": {
                            "requirement_type": "purpose",
                            "expected_value": "prevention or treatment of non-autoimmune allergic diseases"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Need to receive systemic corticosteroids (dose equivalent to > 10 mg prednisone / day)",
                                                "criterion": "systemic corticosteroids",
                                                "requirement": {
                                                    "requirement_type": "dose",
                                                    "expected_value": {
                                                        "operator": ">",
                                                        "value": 10,
                                                        "unit": "mg prednisone / day"
                                                    }
                                                }
                                            },
                                            {
                                                "exact_snippets": "Need to receive ... other immunosuppressive drugs within 14 days before enrollment or during the study period",
                                                "criterion": "immunosuppressive drugs",
                                                "requirement": {
                                                    "requirement_type": "timing",
                                                    "expected_value": "within 14 days before enrollment or during the study period"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "not_criteria": {
                                            "or_criteria": [
                                                {
                                                    "exact_snippets": "Locally external use or inhaled corticosteroids",
                                                    "criterion": "corticosteroids",
                                                    "requirement": {
                                                        "requirement_type": "route of administration",
                                                        "expected_value": [
                                                            "locally external use",
                                                            "inhaled"
                                                        ]
                                                    }
                                                },
                                                {
                                                    "and_criteria": [
                                                        {
                                                            "exact_snippets": "short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases",
                                                            "criterion": "glucocorticoids",
                                                            "requirement": {
                                                                "requirement_type": "duration",
                                                                "expected_value": {
                                                                    "operator": "<=",
                                                                    "value": 7,
                                                                    "unit": "days"
                                                                }
                                                            }
                                                        },
                                                        {
                                                            "exact_snippets": "short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases",
                                                            "criterion": "glucocorticoids",
                                                            "requirement": {
                                                                "requirement_type": "purpose",
                                                                "expected_value": "prevention or treatment of non-autoimmune allergic diseases"
                                                            }
                                                        }
                                                    ]
                                                },
                                                {
                                                    "exact_snippets": "short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases",
                                                    "criterion": "glucocorticoids",
                                                    "requirement": {
                                                        "requirement_type": "purpose",
                                                        "expected_value": "prevention or treatment of non-autoimmune allergic diseases"
                                                    }
                                                }
                                            ]
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Need to receive systemic corticosteroids (dose equivalent to > 10 mg prednisone / day)",
                                "criterion": "systemic corticosteroids",
                                "requirement": {
                                    "requirement_type": "dose",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 10,
                                        "unit": "mg prednisone / day"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Need to receive ... other immunosuppressive drugs within 14 days before enrollment or during the study period",
                                "criterion": "immunosuppressive drugs",
                                "requirement": {
                                    "requirement_type": "timing",
                                    "expected_value": "within 14 days before enrollment or during the study period"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has active digestive ulcer, incomplete intestinal obstruction, active gastrointestinal hemorrhage or perforation.",
                "criterions": [
                    {
                        "exact_snippets": "Has active digestive ulcer",
                        "criterion": "digestive ulcer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "incomplete intestinal obstruction",
                        "criterion": "intestinal obstruction",
                        "requirement": {
                            "requirement_type": "completeness",
                            "expected_value": "incomplete"
                        }
                    },
                    {
                        "exact_snippets": "active gastrointestinal hemorrhage",
                        "criterion": "gastrointestinal hemorrhage",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "active ... perforation",
                        "criterion": "gastrointestinal perforation",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Has active digestive ulcer",
                        "criterion": "digestive ulcer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "incomplete intestinal obstruction",
                        "criterion": "intestinal obstruction",
                        "requirement": {
                            "requirement_type": "completeness",
                            "expected_value": "incomplete"
                        }
                    },
                    {
                        "exact_snippets": "active gastrointestinal hemorrhage",
                        "criterion": "gastrointestinal hemorrhage",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "active ... perforation",
                        "criterion": "gastrointestinal perforation",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has active interstitial pneumonia, pulmonary fibrosis, acute pulmonary disorders, acute radiation pneumonitis, et al.",
                "criterions": [
                    {
                        "exact_snippets": "Has active interstitial pneumonia",
                        "criterion": "interstitial pneumonia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pulmonary fibrosis",
                        "criterion": "pulmonary fibrosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "acute pulmonary disorders",
                        "criterion": "acute pulmonary disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "acute radiation pneumonitis",
                        "criterion": "acute radiation pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Has active interstitial pneumonia",
                        "criterion": "interstitial pneumonia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pulmonary fibrosis",
                        "criterion": "pulmonary fibrosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "acute pulmonary disorders",
                        "criterion": "acute pulmonary disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "acute radiation pneumonitis",
                        "criterion": "acute radiation pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has a history of HIV infection, or other acquired or innate immune deficiency disorders, or a history of organ or stem-cell transplantation.",
                "criterions": [
                    {
                        "exact_snippets": "Has a history of HIV infection",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other acquired or innate immune deficiency disorders",
                        "criterion": "immune deficiency disorders",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "a history of organ or stem-cell transplantation",
                        "criterion": "organ or stem-cell transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Has a history of HIV infection",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other acquired or innate immune deficiency disorders",
                        "criterion": "immune deficiency disorders",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "a history of organ or stem-cell transplantation",
                        "criterion": "organ or stem-cell transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has active chronic HBV or HCV infection, except those with HBV DNA viral load ≤500 IU/mL or <10^3 copies/mL, or HCV RNA negative after adequate treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Has active chronic HBV",
                        "criterion": "active chronic HBV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has active chronic ... HCV infection",
                        "criterion": "active chronic HCV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except those with HBV DNA viral load ≤500 IU/mL or <10^3 copies/mL",
                        "criterion": "HBV DNA viral load",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 500,
                                        "unit": "IU/mL"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 1000,
                                        "unit": "copies/mL"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "except those with ... HCV RNA negative after adequate treatment",
                        "criterion": "HCV RNA",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has active chronic HBV",
                                "criterion": "active chronic HBV infection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "not_criteria": {
                                    "or_criteria": [
                                        {
                                            "exact_snippets": "except those with HBV DNA viral load ≤500 IU/mL or <10^3 copies/mL",
                                            "criterion": "HBV DNA viral load",
                                            "requirement": {
                                                "requirement_type": "quantity",
                                                "expected_value": {
                                                    "comparisons": [
                                                        {
                                                            "operator": "<=",
                                                            "value": 500,
                                                            "unit": "IU/mL"
                                                        },
                                                        {
                                                            "operator": "<",
                                                            "value": 1000,
                                                            "unit": "copies/mL"
                                                        }
                                                    ]
                                                }
                                            }
                                        },
                                        {
                                            "exact_snippets": "except those with ... HCV RNA negative after adequate treatment",
                                            "criterion": "HCV RNA",
                                            "requirement": {
                                                "requirement_type": "presence",
                                                "expected_value": false
                                            }
                                        }
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has active chronic ... HCV infection",
                                "criterion": "active chronic HCV infection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "not_criteria": {
                                    "or_criteria": [
                                        {
                                            "exact_snippets": "except those with HBV DNA viral load ≤500 IU/mL or <10^3 copies/mL",
                                            "criterion": "HBV DNA viral load",
                                            "requirement": {
                                                "requirement_type": "quantity",
                                                "expected_value": {
                                                    "comparisons": [
                                                        {
                                                            "operator": "<=",
                                                            "value": 500,
                                                            "unit": "IU/mL"
                                                        },
                                                        {
                                                            "operator": "<",
                                                            "value": 1000,
                                                            "unit": "copies/mL"
                                                        }
                                                    ]
                                                }
                                            }
                                        },
                                        {
                                            "exact_snippets": "except those with ... HCV RNA negative after adequate treatment",
                                            "criterion": "HCV RNA",
                                            "requirement": {
                                                "requirement_type": "presence",
                                                "expected_value": false
                                            }
                                        }
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has severe infection within 4 weeks or active infection requiring IV infusion or oral administration of antibiotics within 2 weeks prior to the first dose of the study drug.",
                "criterions": [
                    {
                        "exact_snippets": "severe infection within 4 weeks",
                        "criterion": "severe infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "severe infection within 4 weeks",
                        "criterion": "severe infection",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "active infection requiring IV infusion or oral administration of antibiotics within 2 weeks",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "IV infusion",
                                "oral administration of antibiotics"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "active infection requiring IV infusion or oral administration of antibiotics within 2 weeks",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "severe infection within 4 weeks",
                                        "criterion": "severe infection",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "severe infection within 4 weeks",
                                        "criterion": "severe infection",
                                        "requirement": {
                                            "requirement_type": "time frame",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 4,
                                                        "unit": "weeks"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "active infection requiring IV infusion or oral administration of antibiotics within 2 weeks",
                                        "criterion": "active infection",
                                        "requirement": {
                                            "requirement_type": "treatment",
                                            "expected_value": [
                                                "IV infusion",
                                                "oral administration of antibiotics"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "active infection requiring IV infusion or oral administration of antibiotics within 2 weeks",
                                        "criterion": "active infection",
                                        "requirement": {
                                            "requirement_type": "time frame",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 2,
                                                        "unit": "weeks"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known to be allergic to macromolecular protein agents or monoclonal antibody; Known to has a history of severe allergies (CTCAE v5.0 ≥ grade 3) to any of the components in the study drug.",
                "criterions": [
                    {
                        "exact_snippets": "Known to be allergic to macromolecular protein agents",
                        "criterion": "allergy to macromolecular protein agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "allergic to ... monoclonal antibody",
                        "criterion": "allergy to monoclonal antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Known to has a history of severe allergies (CTCAE v5.0 ≥ grade 3)",
                        "criterion": "history of severe allergies",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "allergies ... to any of the components in the study drug",
                        "criterion": "allergy to components in the study drug",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Known to be allergic to macromolecular protein agents",
                                        "criterion": "allergy to macromolecular protein agents",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "allergic to ... monoclonal antibody",
                                        "criterion": "allergy to monoclonal antibody",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Known to has a history of severe allergies (CTCAE v5.0 ≥ grade 3)",
                                        "criterion": "history of severe allergies",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 3,
                                                "unit": "grade"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "allergies ... to any of the components in the study drug",
                                        "criterion": "allergy to components in the study drug",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has participated in other clinical trial within 4 weeks before the first administration of the study drug.",
                "criterions": [
                    {
                        "exact_snippets": "Has participated in other clinical trial within 4 weeks before the first administration of the study drug.",
                        "criterion": "participation in other clinical trial",
                        "requirement": {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Has participated in other clinical trial within 4 weeks before the first administration of the study drug.",
                        "criterion": "participation in other clinical trial",
                        "requirement": {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has a history of confirmed neurological or mental disorders, such as epilepsy, dementia; or with poor compliance; or the presence of peripheral neurological disorders.",
                "criterions": [
                    {
                        "exact_snippets": "history of confirmed neurological or mental disorders, such as epilepsy, dementia",
                        "criterion": "neurological or mental disorders",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "poor compliance",
                        "criterion": "compliance",
                        "requirement": {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    },
                    {
                        "exact_snippets": "presence of peripheral neurological disorders",
                        "criterion": "peripheral neurological disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "history of confirmed neurological or mental disorders, such as epilepsy, dementia",
                                "criterion": "neurological or mental disorders",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "poor compliance",
                                "criterion": "compliance",
                                "requirement": {
                                    "requirement_type": "quality",
                                    "expected_value": "poor"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "presence of peripheral neurological disorders",
                        "criterion": "peripheral neurological disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has symptomatic central nervous system metastasis.",
                "criterions": [
                    {
                        "exact_snippets": "Has symptomatic central nervous system metastasis.",
                        "criterion": "central nervous system metastasis",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Has symptomatic central nervous system metastasis.",
                        "criterion": "central nervous system metastasis",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants with asymptomatic central nervous system metastasis with or without treatment, who have no disease progression by CT / MRI examination, and whose interval from the last radiotherapy is more than 4 weeks, can be enrolled.",
                "criterions": [
                    {
                        "exact_snippets": "asymptomatic central nervous system metastasis",
                        "criterion": "central nervous system metastasis",
                        "requirement": {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    },
                    {
                        "exact_snippets": "no disease progression by CT / MRI examination",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "interval from the last radiotherapy is more than 4 weeks",
                        "criterion": "interval from the last radiotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "asymptomatic central nervous system metastasis",
                                    "criterion": "central nervous system metastasis",
                                    "requirement": {
                                        "requirement_type": "symptoms",
                                        "expected_value": "asymptomatic"
                                    }
                                },
                                {
                                    "exact_snippets": "no disease progression by CT / MRI examination",
                                    "criterion": "disease progression",
                                    "requirement": {
                                        "requirement_type": "progression",
                                        "expected_value": false
                                    }
                                },
                                {
                                    "exact_snippets": "interval from the last radiotherapy is more than 4 weeks",
                                    "criterion": "interval from the last radiotherapy",
                                    "requirement": {
                                        "requirement_type": "time since last treatment",
                                        "expected_value": {
                                            "operator": ">",
                                            "value": 4,
                                            "unit": "weeks"
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants with uncontrollable pleural effusion, peritoneal effusion or pericardial effusion requiring repeated drainage within 7 days before enrollment.",
                "criterions": [
                    {
                        "exact_snippets": "uncontrollable pleural effusion",
                        "criterion": "pleural effusion",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        }
                    },
                    {
                        "exact_snippets": "uncontrollable ... peritoneal effusion",
                        "criterion": "peritoneal effusion",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        }
                    },
                    {
                        "exact_snippets": "uncontrollable ... pericardial effusion",
                        "criterion": "pericardial effusion",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        }
                    },
                    {
                        "exact_snippets": "requiring repeated drainage within 7 days before enrollment",
                        "criterion": "effusion drainage",
                        "requirement": {
                            "requirement_type": "frequency",
                            "expected_value": "repeated"
                        }
                    },
                    {
                        "exact_snippets": "requiring repeated drainage within 7 days before enrollment",
                        "criterion": "effusion drainage",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 7 days before enrollment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "uncontrollable pleural effusion",
                                        "criterion": "pleural effusion",
                                        "requirement": {
                                            "requirement_type": "control",
                                            "expected_value": "uncontrollable"
                                        }
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "requiring repeated drainage within 7 days before enrollment",
                                                "criterion": "effusion drainage",
                                                "requirement": {
                                                    "requirement_type": "frequency",
                                                    "expected_value": "repeated"
                                                }
                                            },
                                            {
                                                "exact_snippets": "requiring repeated drainage within 7 days before enrollment",
                                                "criterion": "effusion drainage",
                                                "requirement": {
                                                    "requirement_type": "time frame",
                                                    "expected_value": "within 7 days before enrollment"
                                                }
                                            }
                                        ]
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "uncontrollable ... peritoneal effusion",
                                        "criterion": "peritoneal effusion",
                                        "requirement": {
                                            "requirement_type": "control",
                                            "expected_value": "uncontrollable"
                                        }
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "requiring repeated drainage within 7 days before enrollment",
                                                "criterion": "effusion drainage",
                                                "requirement": {
                                                    "requirement_type": "frequency",
                                                    "expected_value": "repeated"
                                                }
                                            },
                                            {
                                                "exact_snippets": "requiring repeated drainage within 7 days before enrollment",
                                                "criterion": "effusion drainage",
                                                "requirement": {
                                                    "requirement_type": "time frame",
                                                    "expected_value": "within 7 days before enrollment"
                                                }
                                            }
                                        ]
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "uncontrollable ... pericardial effusion",
                                        "criterion": "pericardial effusion",
                                        "requirement": {
                                            "requirement_type": "control",
                                            "expected_value": "uncontrollable"
                                        }
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "requiring repeated drainage within 7 days before enrollment",
                                                "criterion": "effusion drainage",
                                                "requirement": {
                                                    "requirement_type": "frequency",
                                                    "expected_value": "repeated"
                                                }
                                            },
                                            {
                                                "exact_snippets": "requiring repeated drainage within 7 days before enrollment",
                                                "criterion": "effusion drainage",
                                                "requirement": {
                                                    "requirement_type": "time frame",
                                                    "expected_value": "within 7 days before enrollment"
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants who had received hematopoietic stimulating factors such as colony stimulating factor and erythropoietin within 2 weeks prior to the first dose of study drug",
                "criterions": [
                    {
                        "exact_snippets": "Participants who had received hematopoietic stimulating factors such as colony stimulating factor and erythropoietin within 2 weeks prior to the first dose of study drug",
                        "criterion": "hematopoietic stimulating factors",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Participants who had received hematopoietic stimulating factors such as colony stimulating factor and erythropoietin within 2 weeks prior to the first dose of study drug",
                        "criterion": "hematopoietic stimulating factors",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Other reasons disqualifying the entering of this study based on the evaluation of the investigators.",
                "criterions": [
                    {
                        "exact_snippets": "Other reasons disqualifying the entering of this study based on the evaluation of the investigators.",
                        "criterion": "disqualifying reasons",
                        "requirement": {
                            "requirement_type": "evaluation",
                            "expected_value": "investigators"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Other reasons disqualifying the entering of this study based on the evaluation of the investigators.",
                    "criterion": "disqualifying reasons",
                    "requirement": {
                        "requirement_type": "evaluation",
                        "expected_value": "investigators"
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Diagnosed with stage IV or recurrent or metastatic TNBC who are not suitable for surgical treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosed with stage IV or recurrent or metastatic TNBC",
                        "criterion": "TNBC (Triple Negative Breast Cancer)",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "stage IV",
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "not suitable for surgical treatment",
                        "criterion": "suitability for surgical treatment",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Diagnosed with stage IV or recurrent or metastatic TNBC",
                                "criterion": "TNBC (Triple Negative Breast Cancer)",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "stage IV"
                                }
                            },
                            {
                                "exact_snippets": "Diagnosed with stage IV or recurrent or metastatic TNBC",
                                "criterion": "TNBC (Triple Negative Breast Cancer)",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "recurrent"
                                }
                            },
                            {
                                "exact_snippets": "Diagnosed with stage IV or recurrent or metastatic TNBC",
                                "criterion": "TNBC (Triple Negative Breast Cancer)",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "metastatic"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "not suitable for surgical treatment",
                        "criterion": "suitability for surgical treatment",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Histopathology shows that ER, PR and HER-2 are all negative. If metastasis exists, the histopathology result of metastasis is preferred. ER and PR negative are defined as ER < 1% and PR < 1%. HER-2 negative is defined as HER-2 (-) or (+) in immunohistochemical test. For HER-2 (++), additional negative result should be observed in FISH test. For HER-2 (-) or (+), FISH test is optional, but the result should be negative.",
                "criterions": [
                    {
                        "exact_snippets": "Histopathology shows that ER, PR and HER-2 are all negative.",
                        "criterion": "ER status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Histopathology shows that ER, PR and HER-2 are all negative.",
                        "criterion": "PR status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Histopathology shows that ER, PR and HER-2 are all negative.",
                        "criterion": "HER-2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "If metastasis exists, the histopathology result of metastasis is preferred.",
                        "criterion": "metastasis",
                        "requirement": {
                            "requirement_type": "existence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ER and PR negative are defined as ER < 1% and PR < 1%.",
                        "criterion": "ER percentage",
                        "requirement": {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ER and PR negative are defined as ER < 1% and PR < 1%.",
                        "criterion": "PR percentage",
                        "requirement": {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "HER-2 negative is defined as HER-2 (-) or (+) in immunohistochemical test.",
                        "criterion": "HER-2 immunohistochemical test result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": [
                                "-",
                                "+"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "For HER-2 (++), additional negative result should be observed in FISH test.",
                        "criterion": "HER-2 FISH test result for HER-2 (++)",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "For HER-2 (-) or (+), FISH test is optional, but the result should be negative.",
                        "criterion": "HER-2 FISH test result for HER-2 (-) or (+)",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.",
                "criterions": [
                    {
                        "exact_snippets": "performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score",
                        "criterion": "ECOG Performance Score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score",
                        "criterion": "ECOG Performance Score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "0"
                        }
                    },
                    {
                        "exact_snippets": "performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score",
                        "criterion": "ECOG Performance Score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Renal function: serum creatinine (Scr) ≤1.5×ULN, and endogenous creatinine clearance is more than 50 ml / min (Cockcroft Gault formula);",
                "criterions": [
                    {
                        "exact_snippets": "serum creatinine (Scr) ≤1.5×ULN",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "endogenous creatinine clearance is more than 50 ml / min",
                        "criterion": "endogenous creatinine clearance",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "ml / min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "serum creatinine (Scr) \u00151.5\u001dULN",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "endogenous creatinine clearance is more than 50 ml / min",
                        "criterion": "endogenous creatinine clearance",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "ml / min"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Has uncontrolled systemic diseases, such as cardiovascular and cerebrovascular diseases (unstable angina pectoris, etc.), diabetes, hypertension, tuberculosis, etc;",
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                    {
                        "exact_snippets": "uncontrolled systemic diseases",
                        "criterion": "systemic diseases",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "cardiovascular and cerebrovascular diseases",
                        "criterion": "cardiovascular and cerebrovascular diseases",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unstable angina pectoris",
                        "criterion": "unstable angina pectoris",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "diabetes",
                        "criterion": "diabetes",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "tuberculosis",
                        "criterion": "tuberculosis",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Alcohol dependence or drug abuse within recent one year.",
                "criterions": [
                    {
                        "exact_snippets": "Alcohol dependence",
                        "criterion": "alcohol dependence",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "drug abuse",
                        "criterion": "drug abuse",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "within recent one year",
                        "criterion": "time frame for alcohol dependence or drug abuse",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within recent one year"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Alcohol dependence",
                                "criterion": "alcohol dependence",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "within recent one year",
                                "criterion": "time frame for alcohol dependence or drug abuse",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within recent one year"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "drug abuse",
                                "criterion": "drug abuse",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "within recent one year",
                                "criterion": "time frame for alcohol dependence or drug abuse",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within recent one year"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Is pregnant or breastfeeding.",
                "criterions": [
                    {
                        "exact_snippets": "Is 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": "Is pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}