{
    "info": {
        "nct_id": "NCT04984980",
        "official_title": "Efficacy and Safety of the Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Initially Unresectable Biliary Tract Cancer",
        "inclusion_criteria": "1. Age ≥18 and ≤80 years;\n2. ECOG 0~1;\n3. Histologically or cytologically confirmed carcinoma of the bile duct or gallbladder;\n4. Imaging assessment of disease stage III/IVA/any TN1M0*;\n5. The main organs have good functions and the examination indexes meet the following requirements:\n6. Blood routine test:\n\n   Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophils count ≥1.5×10^9/L; Platelet count ≥80×10^9/L;\n7. Biochemical tests:\n\n   Total bilirubin ≤2×ULN (upper limit of normal value); Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤ 2.5×ULN; Endogenous creatinine clearance rate ≥ 50 mL /min (Cockcroft-Gault formula);\n8. Voluntarily signed the informed consent;\n9. Good compliance and family members are willing to cooperate with follow-up.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "1. Other uncured malignancies;\n2. Pregnant or lactating women, if the subject becomes pregnant during the study period, should withdraw from the clinical trial;\n3. Previous anti-tumor therapy for the disease in this study;\n4. Participated in other drug clinical trials within one month;\n5. Patients with known history of other systemic serious diseases before screening;\n6. Long-term unhealed wounds or incomplete healed fractures;\n7. Have a history of organ transplantation;\n8. Abnormal blood coagulation, with bleeding tendency (14 days before randomization must meet: INR within the normal range without the use of anticoagulants); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; The use of low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (not more than 100 mg daily) for prophylactic purposes is permitted, provided that INR is less than 1.5;\n9. The incidence of arterial/venous thrombosis events in the previous year, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism, was screened;\n10. People with a history of psychotropic substance abuse and unable to get rid of it or with mental disorders; Have a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;\n\n12. Concomitant diseases that, in the Investigator's judgment, seriously endanger patient safety or affect patient completion of the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age ≥18 and ≤80 years;",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 and ≤80 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. ECOG 0~1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG 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"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Histologically or cytologically confirmed carcinoma of the bile duct or gallbladder;",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed carcinoma of the bile duct",
                    "criterion": "carcinoma of the bile duct",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically or cytologically confirmed carcinoma of the ... gallbladder",
                    "criterion": "carcinoma of the gallbladder",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Imaging assessment of disease stage III/IVA/any TN1M0*;",
            "criterions": [
                {
                    "exact_snippets": "Imaging assessment of disease stage III/IVA/any TN1M0",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IVA",
                                "any TN1M0"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. The main organs have good functions and the examination indexes meet the following requirements:",
            "criterions": [
                {
                    "exact_snippets": "The main organs have good functions",
                    "criterion": "main organ functions",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "good"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Blood routine test:",
            "criterions": [
                {
                    "exact_snippets": "Blood routine test",
                    "criterion": "blood routine test",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophils count ≥1.5×10^9/L; Platelet count ≥80×10^9/L;",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥90 g/L (no blood transfusion within 14 days)",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        },
                        {
                            "requirement_type": "blood transfusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Neutrophils count ≥1.5×10^9/L",
                    "criterion": "neutrophils count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count ≥80×10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Biochemical tests:",
            "criterions": [
                {
                    "exact_snippets": "Biochemical tests",
                    "criterion": "biochemical tests",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Total bilirubin ≤2×ULN (upper limit of normal value); Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤ 2.5×ULN; Endogenous creatinine clearance rate ≥ 50 mL /min (Cockcroft-Gault formula);",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤2×ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "×ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Blood alanine aminotransferase (ALT) ... ≤ 2.5×ULN",
                    "criterion": "blood alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "×ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "blood aspartate aminotransferase (AST) ≤ 2.5×ULN",
                    "criterion": "blood aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "×ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Endogenous creatinine clearance rate ≥ 50 mL /min (Cockcroft-Gault formula)",
                    "criterion": "endogenous creatinine clearance rate",
                    "requirements": [
                        {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Voluntarily signed the informed consent;",
            "criterions": [
                {
                    "exact_snippets": "Voluntarily signed the informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "voluntary",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Good compliance and family members are willing to cooperate with follow-up.",
            "criterions": [
                {
                    "exact_snippets": "Good compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    ]
                },
                {
                    "exact_snippets": "family members are willing to cooperate with follow-up",
                    "criterion": "family members' cooperation",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "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 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Other uncured malignancies;",
            "criterions": [
                {
                    "exact_snippets": "Other uncured malignancies",
                    "criterion": "uncured malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Pregnant or lactating women, if the subject becomes pregnant during the study period, should withdraw from the clinical trial;",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Previous anti-tumor therapy for the disease in this study;",
            "criterions": [
                {
                    "exact_snippets": "Previous anti-tumor therapy for the disease",
                    "criterion": "previous anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Participated in other drug clinical trials within one month;",
            "criterions": [
                {
                    "exact_snippets": "Participated in other drug clinical trials within one month",
                    "criterion": "participation in other drug clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients with known history of other systemic serious diseases before screening;",
            "criterions": [
                {
                    "exact_snippets": "known history of other systemic serious diseases",
                    "criterion": "systemic serious diseases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Long-term unhealed wounds or incomplete healed fractures;",
            "criterions": [
                {
                    "exact_snippets": "Long-term unhealed wounds",
                    "criterion": "wounds",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "long-term"
                        }
                    ]
                },
                {
                    "exact_snippets": "incomplete healed fractures",
                    "criterion": "fractures",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "incomplete"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Have a history of organ transplantation;",
            "criterions": [
                {
                    "exact_snippets": "history of organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Abnormal blood coagulation, with bleeding tendency (14 days before randomization must meet: INR within the normal range without the use of anticoagulants); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; The use of low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (not more than 100 mg daily) for prophylactic purposes is permitted, provided that INR is less than 1.5;",
            "criterions": [
                {
                    "exact_snippets": "Abnormal blood coagulation, with bleeding tendency",
                    "criterion": "blood coagulation",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "bleeding tendency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "INR within the normal range without the use of anticoagulants",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within the normal range"
                        },
                        {
                            "requirement_type": "anticoagulant use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs",
                    "criterion": "anticoagulant or vitamin K antagonist treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The use of low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (not more than 100 mg daily) for prophylactic purposes is permitted, provided that INR is less than 1.5",
                    "criterion": "low-dose warfarin or aspirin use",
                    "requirements": [
                        {
                            "requirement_type": "prophylactic use",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "INR",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. The incidence of arterial/venous thrombosis events in the previous year, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism, was screened;",
            "criterions": [
                {
                    "exact_snippets": "incidence of arterial/venous thrombosis events in the previous year",
                    "criterion": "arterial/venous thrombosis events",
                    "requirements": [
                        {
                            "requirement_type": "incidence",
                            "expected_value": "in the previous year"
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular accident (including temporary ischemic attack)",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "deep venous thrombosis",
                    "criterion": "deep venous thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. People with a history of psychotropic substance abuse and unable to get rid of it or with mental disorders; Have a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;",
            "criterions": [
                {
                    "exact_snippets": "history of psychotropic substance abuse",
                    "criterion": "psychotropic substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to get rid of it",
                    "criterion": "psychotropic substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": "unable to quit"
                        }
                    ]
                },
                {
                    "exact_snippets": "mental disorders",
                    "criterion": "mental disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acquired or congenital immunodeficiency diseases",
                    "criterion": "immunodeficiency diseases",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "acquired",
                                "congenital"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "history of organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Concomitant diseases that, in the Investigator's judgment, seriously endanger patient safety or affect patient completion of the study.",
            "criterions": [
                {
                    "exact_snippets": "Concomitant diseases ... seriously endanger patient safety",
                    "criterion": "concomitant diseases",
                    "requirements": [
                        {
                            "requirement_type": "impact on patient safety",
                            "expected_value": "seriously endanger"
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant diseases ... affect patient completion of the study",
                    "criterion": "concomitant diseases",
                    "requirements": [
                        {
                            "requirement_type": "impact on study completion",
                            "expected_value": "affect"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}