{
    "info": {
        "nct_id": "NCT02857166",
        "official_title": "Phase IA Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Recombinant Humanized Anti-PD-1 Monoclonal Antibody (JS001) in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "1. Histological or cytological diagnosis of advanced or recurrent adenocarcinoma of solid tumor, including adenocarcinoma of the stomach or gastro-esophageal junction, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, cholangiocarcinoma, Pancreatic ductal cell carcinoma, etc.\n\n   * at least one prior chemotherapy regimen\n   * age between 18 and 75 years, both gender\n   * has at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST V1.1)\n2. life expectancy ≥ 3 months\n3. ECOG performance status of 0 or 1\n4. Has had last dose of chemotherapy more than 4 weeks prior to the first dose of study therapy JS001, and has recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade 1 or better from the AEs due to the chemotherapy.\n5. Has had last administration of radioactive therapy more than 4 weeks prior to the first dose of study therapy JS001.\n6. Has had last administration of immunosuppressive systemic steroid therapy (more than 10 mg/d prednisone or equal dose) more than 2 weeks prior to the first dose of study therapy JS001.\n7. Has undergone major surgery that needs general anesthesia more than 4 weeks prior to the first dose of study therapy JS001. Has undergone surgery that needs local anesthesia or epidural anesthesia more than 72 hours prior to the first dose of study therapy JS001 and has already recovered from the surgery. Has undergone biopsy more than 1 hour prior to the first dose of study therapy JS001.\n8. The lab examination results of the screening must fulfill all of the following:\n\n   * absolute neutrophil count more than or equal to 1.5×109/ L\n   * platelet count more than or equal to 90×109/ L\n   * hemoglobin more than or equal to 90 g/L\n   * creatinine less than or equal to132.6µmol/L or creatinine clearance >40 mL/min\n   * aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 3.0 ×ULN\n   * total bilirubin less than or equal to 1.5×ULN( except for the patients with Gilbert syndrome, whose total bilirubin ,must less than or equal to 51.3µmol/L)\n9. Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to participation in any study related activities.\n10. Able to adhere to the study visit schedule and other protocol requirements.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Has had antineoplastic herbal therapy within 2 weeks prior to the first dose of study therapy JS001.\n2. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and receive study therapy or used an investigational device within 4 weeks of the first dose of study drug.\n3. Has a medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication.\n4. Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years.\n5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n6. Has interstitial lung disease OR has had a history of pneumonitis that has required oral or IV steroids.\n7. Has active or suspected autoimmune disease except leukoderma,type I Diabetes, Residual hypothyroidism that induced by autoimmune thyroiditis and only requires the use of hormone replacement therapy, Or disease that rarely relapse without external stimulating factors.\n8. Had prior treatment targeting PD-1: anti-PD-1,anti-PD-L1, anti-PD-L2, cytotoxic T-lymphocyte-associated protein (CTLA), or other antibodies that targeting T cell costimulatory pathway or checkpoint.\n9. Has an active infection requiring systematic therapy.\n10. Is positive for Human Immunodeficiency Virus (HIV).\n11. Has active Tuberculosis.\n12. Has known active Hepatitis B or C.\n13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n14. Has received or will receive a live vaccine within 30 days prior to the first administration of study drug.\n15. Is pregnant or breastfeeding.\n16. Cannot tolerate vein puncture and / or venous access.\n17. Any other conclusive medical reasons, mental illness, and / or social reasons that determined by the investigators.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histological or cytological diagnosis of advanced or recurrent adenocarcinoma of solid tumor, including adenocarcinoma of the stomach or gastro-esophageal junction, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, cholangiocarcinoma, Pancreatic ductal cell carcinoma, etc.",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological diagnosis of advanced or recurrent adenocarcinoma of solid tumor",
                    "criterion": "adenocarcinoma of solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "histological or cytological"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced or recurrent"
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of the stomach or gastro-esophageal junction",
                    "criterion": "adenocarcinoma of the stomach or gastro-esophageal junction",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "esophageal squamous cell carcinoma",
                    "criterion": "esophageal squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "squamous cell carcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "nasopharyngeal carcinoma",
                    "criterion": "nasopharyngeal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "carcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "cholangiocarcinoma",
                    "criterion": "cholangiocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "cholangiocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "Pancreatic ductal cell carcinoma",
                    "criterion": "Pancreatic ductal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "ductal cell carcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* at least one prior chemotherapy regimen",
            "criterions": [
                {
                    "exact_snippets": "at least one prior chemotherapy regimen",
                    "criterion": "prior chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* age between 18 and 75 years, both gender",
            "criterions": [
                {
                    "exact_snippets": "age between 18 and 75 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "both gender",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* has at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST V1.1)",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST V1.1)",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "disease"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. life expectancy ≥ 3 months",
            "criterions": [
                {
                    "exact_snippets": "life expectancy ≥ 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ECOG performance status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Has had last dose of chemotherapy more than 4 weeks prior to the first dose of study therapy JS001, and has recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade 1 or better from the AEs due to the chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Has had last dose of chemotherapy more than 4 weeks prior to the first dose of study therapy JS001",
                    "criterion": "time since last chemotherapy dose",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "has recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade 1 or better from the AEs due to the chemotherapy",
                    "criterion": "recovery from chemotherapy adverse events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Has had last administration of radioactive therapy more than 4 weeks prior to the first dose of study therapy JS001.",
            "criterions": [
                {
                    "exact_snippets": "last administration of radioactive therapy more than 4 weeks prior to the first dose of study therapy JS001",
                    "criterion": "radioactive therapy administration",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Has had last administration of immunosuppressive systemic steroid therapy (more than 10 mg/d prednisone or equal dose) more than 2 weeks prior to the first dose of study therapy JS001.",
            "criterions": [
                {
                    "exact_snippets": "last administration of immunosuppressive systemic steroid therapy",
                    "criterion": "immunosuppressive systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "more than 10 mg/d prednisone or equal dose",
                    "criterion": "steroid dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/d"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Has undergone major surgery that needs general anesthesia more than 4 weeks prior to the first dose of study therapy JS001. Has undergone surgery that needs local anesthesia or epidural anesthesia more than 72 hours prior to the first dose of study therapy JS001 and has already recovered from the surgery. Has undergone biopsy more than 1 hour prior to the first dose of study therapy JS001.",
            "criterions": [
                {
                    "exact_snippets": "Has undergone major surgery that needs general anesthesia more than 4 weeks prior to the first dose of study therapy JS001.",
                    "criterion": "major surgery with general anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Has undergone surgery that needs local anesthesia or epidural anesthesia more than 72 hours prior to the first dose of study therapy JS001 and has already recovered from the surgery.",
                    "criterion": "surgery with local or epidural anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">",
                                "value": 72,
                                "unit": "hours"
                            }
                        },
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has undergone biopsy more than 1 hour prior to the first dose of study therapy JS001.",
                    "criterion": "biopsy",
                    "requirements": [
                        {
                            "requirement_type": "time since biopsy",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "hour"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. The lab examination results of the screening must fulfill all of the following:",
            "criterions": [
                {
                    "exact_snippets": "lab examination results",
                    "criterion": "lab examination results",
                    "requirements": [
                        {
                            "requirement_type": "fulfillment",
                            "expected_value": "all of the following"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* absolute neutrophil count more than or equal to 1.5×109/ L",
            "criterions": [
                {
                    "exact_snippets": "absolute neutrophil count more than or equal to 1.5×109/ L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* platelet count more than or equal to 90×109/ L",
            "criterions": [
                {
                    "exact_snippets": "platelet count more than or equal to 90×109/ L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* hemoglobin more than or equal to 90 g/L",
            "criterions": [
                {
                    "exact_snippets": "hemoglobin more than or equal to 90 g/L",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* creatinine less than or equal to132.6µmol/L or creatinine clearance >40 mL/min",
            "criterions": [
                {
                    "exact_snippets": "creatinine less than or equal to132.6µmol/L",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 132.6,
                                "unit": "µmol/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance >40 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "clearance",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 3.0 ×ULN",
            "criterions": [
                {
                    "exact_snippets": "aspartate transferase(AST) ... less than or equal to 3.0 ×ULN",
                    "criterion": "aspartate transferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "×ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine transferase(ALT) less than or equal to 3.0 ×ULN",
                    "criterion": "alanine transferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "×ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* total bilirubin less than or equal to 1.5×ULN( except for the patients with Gilbert syndrome, whose total bilirubin ,must less than or equal to 51.3µmol/L)",
            "criterions": [
                {
                    "exact_snippets": "total bilirubin less than or equal to 1.5×ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with Gilbert syndrome, whose total bilirubin ,must less than or equal to 51.3µmol/L",
                    "criterion": "total bilirubin in patients with Gilbert syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 51.3,
                                "unit": "µmol/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to participation in any study related activities.",
            "criterions": [
                {
                    "exact_snippets": "Patient has been informed about the nature of the study",
                    "criterion": "informed about the nature of the study",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has agreed to participate in the study",
                    "criterion": "agreement to participate",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signed the Informed Consent Form",
                    "criterion": "Informed Consent Form",
                    "requirements": [
                        {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Able to adhere to the study visit schedule and other protocol requirements.",
            "criterions": [
                {
                    "exact_snippets": "Able to adhere to the study visit schedule",
                    "criterion": "adherence to study visit schedule",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Able to adhere to ... other protocol requirements",
                    "criterion": "adherence to protocol requirements",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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. Has had antineoplastic herbal therapy within 2 weeks prior to the first dose of study therapy JS001.",
            "criterions": [
                {
                    "exact_snippets": "Has had antineoplastic herbal therapy within 2 weeks prior to the first dose of study therapy JS001.",
                    "criterion": "antineoplastic herbal therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and receive study therapy or used an investigational device within 4 weeks of the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Is currently participating and receiving study therapy",
                    "criterion": "current participation in a study",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "receiving therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has participated in a study of an investigational agent and receive study therapy",
                    "criterion": "past participation in a study",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "receiving therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "used an investigational device within 4 weeks of the first dose of study drug",
                    "criterion": "use of investigational device",
                    "requirements": [
                        {
                            "requirement_type": "time since use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Has a medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication.",
            "criterions": [
                {
                    "exact_snippets": "Has a medical condition that requires chronic systemic steroid therapy",
                    "criterion": "chronic systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "on any other form of immunosuppressive medication",
                    "criterion": "immunosuppressive medication",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years.",
            "criterions": [
                {
                    "exact_snippets": "known history of a hematologic malignancy",
                    "criterion": "hematologic malignancy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known history of a ... primary brain tumor",
                    "criterion": "primary brain tumor",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known history of a ... sarcoma",
                    "criterion": "sarcoma",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known history of a ... another primary solid tumor",
                    "criterion": "another primary solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergone potentially curative therapy with no evidence of that disease for 5 years",
                    "criterion": "curative therapy and disease evidence",
                    "requirements": [
                        {
                            "requirement_type": "therapy",
                            "expected_value": "potentially curative"
                        },
                        {
                            "requirement_type": "disease evidence",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.",
            "criterions": [
                {
                    "exact_snippets": "known active central nervous system (CNS) metastases",
                    "criterion": "central nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Has interstitial lung disease OR has had a history of pneumonitis that has required oral or IV steroids.",
            "criterions": [
                {
                    "exact_snippets": "Has interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has had a history of pneumonitis ... required oral or IV steroids",
                    "criterion": "history of pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "oral steroids",
                                "IV steroids"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Has active or suspected autoimmune disease except leukoderma,type I Diabetes, Residual hypothyroidism that induced by autoimmune thyroiditis and only requires the use of hormone replacement therapy, Or disease that rarely relapse without external stimulating factors.",
            "criterions": [
                {
                    "exact_snippets": "Has active or suspected autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except leukoderma",
                    "criterion": "leukoderma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... type I Diabetes",
                    "criterion": "type I Diabetes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... Residual hypothyroidism that induced by autoimmune thyroiditis and only requires the use of hormone replacement therapy",
                    "criterion": "residual hypothyroidism induced by autoimmune thyroiditis",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "hormone replacement therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... disease that rarely relapse without external stimulating factors",
                    "criterion": "disease that rarely relapse without external stimulating factors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Has an active infection requiring systematic therapy.",
            "criterions": [
                {
                    "exact_snippets": "active infection requiring systematic therapy",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systematic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Is positive for Human Immunodeficiency Virus (HIV).",
            "criterions": [
                {
                    "exact_snippets": "positive for Human Immunodeficiency Virus (HIV)",
                    "criterion": "Human Immunodeficiency Virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Has active Tuberculosis.",
            "criterions": [
                {
                    "exact_snippets": "Has active Tuberculosis",
                    "criterion": "Tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Has known active Hepatitis B or C.",
            "criterions": [
                {
                    "exact_snippets": "Has known active Hepatitis B",
                    "criterion": "Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Has known active ... C",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.",
            "criterions": [
                {
                    "exact_snippets": "known psychiatric ... disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "substance abuse disorders",
                    "criterion": "substance abuse disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Has received or will receive a live vaccine within 30 days prior to the first administration of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Has received or will receive a live vaccine within 30 days prior to the first administration of study drug.",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Is pregnant or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Cannot tolerate vein puncture and / or venous access.",
            "criterions": [
                {
                    "exact_snippets": "Cannot tolerate vein puncture",
                    "criterion": "vein puncture tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Cannot tolerate ... venous access",
                    "criterion": "venous access tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Any other conclusive medical reasons, mental illness, and / or social reasons that determined by the investigators.",
            "criterions": [
                {
                    "exact_snippets": "Any other conclusive medical reasons",
                    "criterion": "conclusive medical reasons",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "mental illness",
                    "criterion": "mental illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "social reasons",
                    "criterion": "social reasons",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "8. Had prior treatment targeting PD-1: anti-PD-1,anti-PD-L1, anti-PD-L2, cytotoxic T-lymphocyte-associated protein (CTLA), or other antibodies that targeting T cell costimulatory pathway or checkpoint.",
            "criterions": [
                {
                    "exact_snippets": "prior treatment targeting PD-1: anti-PD-1, anti-PD-L1, anti-PD-L2",
                    "criterion": "prior treatment targeting PD-1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior treatment targeting ... cytotoxic T-lymphocyte-associated protein (CTLA)",
                    "criterion": "prior treatment targeting CTLA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior treatment targeting ... other antibodies that targeting T cell costimulatory pathway or checkpoint",
                    "criterion": "prior treatment targeting T cell costimulatory pathway or checkpoint",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}