{
    "info": {
        "nct_id": "NCT04636762",
        "official_title": "A Multi-center, Single Arm , Phase II Study of Atezolizumab Combined With Concurrent Chemoradiotherapy and Maintenance Therapy With Atezolizumab in Untreated Participants With Extensive-stage Small Cell Lung Cancer",
        "inclusion_criteria": "1.Histologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system) 2.Must sign a written informed consent form prior to any study specific procedures 3. No prior treatment for ES-SCLC 4.Measurable disease, as defined by RECIST v1.1 5.Can tolerate radiotherapy, no contraindication of radiotherapy 6.Weight≥40kg 7.Life expectancy>12 weeks 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1. 9.Systemic immunosuppressive doses of corticosteroids (prednisone>10 mg/d or equivalent) was discontinued at least 2 weeks before registration for protocol therapy.\n\n10. Be willing to provide 20 tissue sections(4-6 micron thickness) from a newly obtained core or excisional biopsy of a tumor lesion, for biomarker exploration; newly-obtained is defined as a specimen obtained within 3 months before initiation of treatment on day 1; newly-obtained samples must be core needle biopsy, excision, or incision 11.Must have adequate organ function defined by the following laboratory results:\n\n1. Absolute neutrophil count (ANC) ≥ 1.5×109/L, Platelets≥ 100×109/L, Hemoglobin≥90g/L\n2. Serum creatinine ≤ 1.5 upper limit of normal (ULN) OR calculated creatinine clearance≥60 mL/min(using Cock-Gault formula)\n3. Total bilirubin ≤1.5 ULN or for total bilirubin level ≥1.5 ULN, direct bilirubin is within normal limits; AST (SGOT) and ALT (SGPT)≤2.5 ULN.\n4. The thyroid-stimulating hormone (TSH) is within normal range. Note: If the Baseline TSH is not within the normal range, and T3 and T4 are within the normal range, the subject may still meet the inclusion criteria.\n5. International normalized ratio(INR) or prothrombin time(PT), activated partial thromboplastin time (APTT)≤1.5 ULN, exception: In subjects receiving anticoagulant therapy, as long as PT or APTT is within the recommended use of anticoagulants\n6. Baseline ECG showed no prolonged PR interval or atrioventricular block. 12.Women of child-bearing potential should agree that contraception (such as intrauterine devices(LUD), birth control pills or condoms) must be used during the course of the study through 6 months after the last dose of study medication, and women of childbearing potential should have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication and must be a non-lactation participant; the male participants agree to use contraception during the study period and for 6 months after the end of the study period.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Hypersensitivity to Atezolizumab\n2. Carcinomatous meningitis.\n3. History of active Bacillus tuberculosis (TB)\n4. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n5. HIV positive or with Acquired Immune Deficiency Syndrome\n6. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy\n7. History of, or any evidence of active, non-infectious pneumonitis\n8. Immunosuppressive drug was used 2 weeks prior to the first study drug treatment, excluding topical glucocorticoid, systematic glucocorticoid not exceeding 10 mg/d of prednisone or equivalent dose of other glucocorticoid\n9. Received a live vaccine within 30 days of planned start of study therapy\n10. Received a prior anti-cancer monoclonal antibody (mAb) within 3 months prior to study day 1\n11. Has taken Chinese herbal medicine for anti-cancer purpose in the past 2 weeks\n12. Known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (HCV) (e.g., HCV ribonucleic acid [RNA] [qualitative] is detected)\n13. Active infection requiring systemic therapy\n14. Known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer\n15. Bleeding tendency, such as active peptic ulcer, or treated with anticoagulants or vitamin K antagonists, such as Warfarin, Heparin, or their analogues\n16. Any severe and/or uncontrolled disease, such as: (1) unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months prior to randomization, severe uncontrolled arrhythmia; poor blood pressure control (SBP>140 mmHg, DBP>90 mmHg) ; (2)active or uncontrolled severe infection; (3)liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis; (4) poor control of diabetes (FBG>10mmol/l) ; (5) urine routine suggested urinary protein ≥ + + and 24-hour urinary protein quantitation >1.0 g; (6) history of psychotropic substance abuse and could not be cured or had mental disorder\n17. Prisoner who is imprisoned or forcibly detained for reasons other than mental or physical (e.g. infectious) disease\n18. Can not tolerate venipuncture\n19. Pregnant or lactating women\n20. Other conditions that researchers consider unsuitable for participation -",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1.Histologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system) 2.Must sign a written informed consent form prior to any study specific procedures 3. No prior treatment for ES-SCLC 4.Measurable disease, as defined by RECIST v1.1 5.Can tolerate radiotherapy, no contraindication of radiotherapy 6.Weight≥40kg 7.Life expectancy>12 weeks 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1. 9.Systemic immunosuppressive doses of corticosteroids (prednisone>10 mg/d or equivalent) was discontinued at least 2 weeks before registration for protocol therapy.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed ES-SCLC",
                    "criterion": "ES-SCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Must sign a written informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior treatment for ES-SCLC",
                    "criterion": "prior treatment for ES-SCLC",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable disease, as defined by RECIST v1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Can tolerate radiotherapy, no contraindication of radiotherapy",
                    "criterion": "radiotherapy tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "contraindication",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Weight≥40kg",
                    "criterion": "weight",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "kg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Life expectancy>12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Systemic immunosuppressive doses of corticosteroids (prednisone>10 mg/d or equivalent) was discontinued at least 2 weeks before registration for protocol therapy",
                    "criterion": "corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/d"
                            }
                        },
                        {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Be willing to provide 20 tissue sections(4-6 micron thickness) from a newly obtained core or excisional biopsy of a tumor lesion, for biomarker exploration; newly-obtained is defined as a specimen obtained within 3 months before initiation of treatment on day 1; newly-obtained samples must be core needle biopsy, excision, or incision 11.Must have adequate organ function defined by the following laboratory results:",
            "criterions": [
                {
                    "exact_snippets": "willing to provide 20 tissue sections(4-6 micron thickness) from a newly obtained core or excisional biopsy of a tumor lesion",
                    "criterion": "tissue sections from biopsy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 20,
                                "unit": "sections"
                            }
                        },
                        {
                            "requirement_type": "thickness",
                            "expected_value": {
                                "operator": "=",
                                "value": 4,
                                "unit": "micron"
                            }
                        },
                        {
                            "requirement_type": "thickness",
                            "expected_value": {
                                "operator": "=",
                                "value": 6,
                                "unit": "micron"
                            }
                        },
                        {
                            "requirement_type": "source",
                            "expected_value": [
                                "core biopsy",
                                "excisional biopsy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "newly-obtained is defined as a specimen obtained within 3 months before initiation of treatment on day 1",
                    "criterion": "newly-obtained specimen",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "newly-obtained samples must be core needle biopsy, excision, or incision",
                    "criterion": "newly-obtained samples",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "core needle biopsy",
                                "excision",
                                "incision"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Absolute neutrophil count (ANC) ≥ 1.5×109/L, Platelets≥ 100×109/L, Hemoglobin≥90g/L",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5×109/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets≥ 100×109/L",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin≥90g/L",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Serum creatinine ≤ 1.5 upper limit of normal (ULN) OR calculated creatinine clearance≥60 mL/min(using Cock-Gault formula)",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5 upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated creatinine clearance≥60 mL/min(using Cock-Gault formula)",
                    "criterion": "calculated creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Total bilirubin ≤1.5 ULN or for total bilirubin level ≥1.5 ULN, direct bilirubin is within normal limits; AST (SGOT) and ALT (SGPT)≤2.5 ULN.",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤1.5 ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin level ≥1.5 ULN, direct bilirubin is within normal limits",
                    "criterion": "direct bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "within normal limits"
                        }
                    ]
                },
                {
                    "exact_snippets": "AST (SGOT) and ALT (SGPT)≤2.5 ULN",
                    "criterion": "AST (SGOT) and ALT (SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. The thyroid-stimulating hormone (TSH) is within normal range. Note: If the Baseline TSH is not within the normal range, and T3 and T4 are within the normal range, the subject may still meet the inclusion criteria.",
            "criterions": [
                {
                    "exact_snippets": "The thyroid-stimulating hormone (TSH) is within normal range.",
                    "criterion": "thyroid-stimulating hormone (TSH)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "T3 and T4 are within the normal range",
                    "criterion": "T3",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "T3 and T4 are within the normal range",
                    "criterion": "T4",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within normal range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. International normalized ratio(INR) or prothrombin time(PT), activated partial thromboplastin time (APTT)≤1.5 ULN, exception: In subjects receiving anticoagulant therapy, as long as PT or APTT is within the recommended use of anticoagulants",
            "criterions": [
                {
                    "exact_snippets": "International normalized ratio(INR) ... ≤1.5 ULN",
                    "criterion": "International normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prothrombin time(PT) ... ≤1.5 ULN",
                    "criterion": "prothrombin time (PT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "activated partial thromboplastin time (APTT)≤1.5 ULN",
                    "criterion": "activated partial thromboplastin time (APTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects receiving anticoagulant therapy ... PT or APTT is within the recommended use of anticoagulants",
                    "criterion": "anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "PT or APTT is within the recommended use of anticoagulants"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Baseline ECG showed no prolonged PR interval or atrioventricular block. 12.Women of child-bearing potential should agree that contraception (such as intrauterine devices(LUD), birth control pills or condoms) must be used during the course of the study through 6 months after the last dose of study medication, and women of childbearing potential should have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication and must be a non-lactation participant; the male participants agree to use contraception during the study period and for 6 months after the end of the study period.",
            "criterions": [
                {
                    "exact_snippets": "Baseline ECG showed no prolonged PR interval",
                    "criterion": "PR interval",
                    "requirements": [
                        {
                            "requirement_type": "prolongation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Baseline ECG showed no ... atrioventricular block",
                    "criterion": "atrioventricular block",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of child-bearing potential",
                    "criterion": "child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "women of child-bearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of child-bearing potential should agree that contraception ... must be used during the course of the study through 6 months after the last dose of study medication",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the course of the study through 6 months after the last dose of study medication"
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential should have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to receiving the first dose of study medication"
                        }
                    ]
                },
                {
                    "exact_snippets": "must be a non-lactation participant",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "non-lactation"
                        }
                    ]
                },
                {
                    "exact_snippets": "male participants agree to use contraception during the study period and for 6 months after the end of the study period",
                    "criterion": "contraception use (male participants)",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study period and for 6 months after the end of the study period"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Hypersensitivity to Atezolizumab",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to Atezolizumab",
                    "criterion": "hypersensitivity to Atezolizumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Carcinomatous meningitis.",
            "criterions": [
                {
                    "exact_snippets": "Carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. History of active Bacillus tuberculosis (TB)",
            "criterions": [
                {
                    "exact_snippets": "History of active Bacillus tuberculosis (TB)",
                    "criterion": "active Bacillus tuberculosis (TB)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune disease that has required systemic treatment in the past 2 years",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment",
                    "criterion": "replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "not considered systemic treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. HIV positive or with Acquired Immune Deficiency Syndrome",
            "criterions": [
                {
                    "exact_snippets": "HIV positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Acquired Immune Deficiency Syndrome",
                    "criterion": "Acquired Immune Deficiency Syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving systemic steroid therapy",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving ... any other form of immunosuppressive therapy",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of, or any evidence of active, non-infectious pneumonitis",
            "criterions": [
                {
                    "exact_snippets": "History of, or any evidence of active, non-infectious pneumonitis",
                    "criterion": "non-infectious pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Immunosuppressive drug was used 2 weeks prior to the first study drug treatment, excluding topical glucocorticoid, systematic glucocorticoid not exceeding 10 mg/d of prednisone or equivalent dose of other glucocorticoid",
            "criterions": [
                {
                    "exact_snippets": "Immunosuppressive drug was used 2 weeks prior to the first study drug treatment",
                    "criterion": "immunosuppressive drug use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "2 weeks prior to the first study drug treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding topical glucocorticoid",
                    "criterion": "topical glucocorticoid use",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systematic glucocorticoid not exceeding 10 mg/d of prednisone or equivalent dose of other glucocorticoid",
                    "criterion": "systematic glucocorticoid use",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg/d of prednisone or equivalent dose of other glucocorticoid"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Received a live vaccine within 30 days of planned start of study therapy",
            "criterions": [
                {
                    "exact_snippets": "Received a live vaccine within 30 days of planned start of study therapy",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Received a prior anti-cancer monoclonal antibody (mAb) within 3 months prior to study day 1",
            "criterions": [
                {
                    "exact_snippets": "Received a prior anti-cancer monoclonal antibody (mAb) within 3 months prior to study day 1",
                    "criterion": "prior anti-cancer monoclonal antibody (mAb)",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Has taken Chinese herbal medicine for anti-cancer purpose in the past 2 weeks",
            "criterions": [
                {
                    "exact_snippets": "Has taken Chinese herbal medicine for anti-cancer purpose in the past 2 weeks",
                    "criterion": "Chinese herbal medicine",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "anti-cancer"
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "past 2 weeks"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (HCV) (e.g., HCV ribonucleic acid [RNA] [qualitative] is detected)",
            "criterions": [
                {
                    "exact_snippets": "Known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive)",
                    "criterion": "active hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C (HCV) (e.g., HCV ribonucleic acid [RNA] [qualitative] is detected)",
                    "criterion": "active hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Active infection requiring systemic therapy",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring systemic therapy",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer",
            "criterions": [
                {
                    "exact_snippets": "Known additional malignancy that is progressing or requires active treatment",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions include basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions include ... squamous cell carcinoma of the skin that has undergone potentially curative therapy",
                    "criterion": "squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "potentially curative therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions include ... in situ cervical cancer",
                    "criterion": "in situ cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Bleeding tendency, such as active peptic ulcer, or treated with anticoagulants or vitamin K antagonists, such as Warfarin, Heparin, or their analogues",
            "criterions": [
                {
                    "exact_snippets": "Bleeding tendency",
                    "criterion": "bleeding tendency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active peptic ulcer",
                    "criterion": "active peptic ulcer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with anticoagulants or vitamin K antagonists, such as Warfarin, Heparin, or their analogues",
                    "criterion": "treatment with anticoagulants or vitamin K antagonists",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Any severe and/or uncontrolled disease, such as: (1) unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months prior to randomization, severe uncontrolled arrhythmia; poor blood pressure control (SBP>140 mmHg, DBP>90 mmHg) ; (2)active or uncontrolled severe infection; (3)liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis; (4) poor control of diabetes (FBG>10mmol/l) ; (5) urine routine suggested urinary protein ≥ + + and 24-hour urinary protein quantitation >1.0 g; (6) history of psychotropic substance abuse and could not be cured or had mental disorder",
            "criterions": [
                {
                    "exact_snippets": "severe and/or uncontrolled disease, such as: (1) unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe and/or uncontrolled disease, such as: ... symptomatic congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "symptomatic"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe and/or uncontrolled disease, such as: ... myocardial infarction within 6 months prior to randomization",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "severe and/or uncontrolled disease, such as: ... severe uncontrolled arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "poor blood pressure control (SBP>140 mmHg, DBP>90 mmHg)",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poor"
                        },
                        {
                            "requirement_type": "systolic blood pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 140,
                                "unit": "mmHg"
                            }
                        },
                        {
                            "requirement_type": "diastolic blood pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "active or uncontrolled severe infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis",
                    "criterion": "liver diseases",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "cirrhosis",
                                "decompensated liver disease",
                                "chronic active hepatitis"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "poor control of diabetes (FBG>10mmol/l)",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poor"
                        },
                        {
                            "requirement_type": "fasting blood glucose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mmol/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "urine routine suggested urinary protein ≥ + + and 24-hour urinary protein quantitation >1.0 g",
                    "criterion": "urinary protein",
                    "requirements": [
                        {
                            "requirement_type": "urine routine",
                            "expected_value": ">= + +"
                        },
                        {
                            "requirement_type": "24-hour urinary protein quantitation",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.0,
                                "unit": "g"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of psychotropic substance abuse and could not be cured or had mental disorder",
                    "criterion": "psychotropic substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "cure status",
                            "expected_value": "could not be cured"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... mental disorder",
                    "criterion": "mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Prisoner who is imprisoned or forcibly detained for reasons other than mental or physical (e.g. infectious) disease",
            "criterions": [
                {
                    "exact_snippets": "Prisoner who is imprisoned or forcibly detained",
                    "criterion": "prisoner status",
                    "requirements": [
                        {
                            "requirement_type": "reason for imprisonment",
                            "expected_value": {
                                "operator": "!=",
                                "value": 1,
                                "unit": "mental or physical (e.g. infectious) disease"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Can not tolerate venipuncture",
            "criterions": [
                {
                    "exact_snippets": "Can not tolerate venipuncture",
                    "criterion": "venipuncture tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Pregnant or lactating women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Other conditions that researchers consider unsuitable for participation -",
            "criterions": [
                {
                    "exact_snippets": "Other conditions that researchers consider unsuitable for participation",
                    "criterion": "other conditions",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}