combination of gemcitabine, oxaliplatin, sintilimab and bevacizumab in unresectable biliary tract cancer

Conditions: Biliary Tract Carcinoma; Initially Unresectable

Summary: study design: prospective, single-arm, single-center phase ii clinical study; primary endpoint: conversion rate; secondary endpoints: safety, disease control rate, disease-free survival, and overall survival; main characteristics of enrolled patients: patients with initially unresectable biliary tract cancer; interventions: combination of gemcitabine, oxaliplatin, sintilimab and bevacizumab; sample size: 34 patients; treatment until: 1. successfully conversed to resectable disease 2. progressed disease 3. intolerable toxicity 4. patient requests withdrawal; research process: in this study, patients who met the inclusion criteria were evaluated at the end of every 3 weeks of treatment, up to surgical treatment or disease progression; safety evaluation: evaluate adverse reactions according to ctcae 4.0; follow up: 12 months after the last case was enrolled.


Eligibility criteria:
inclusion criteria: 1. age ≥18 and ≤80 years; 2. ecog 0\~1; 3. histologically or cytologically confirmed carcinoma of the bile duct or gallbladder; 4. imaging assessment of disease stage iii/iva/any tn1m0\*; 5. the main organs have good functions and the examination indexes meet the following requirements: 6. blood routine test: hemoglobin ≥90 g/l (no blood transfusion within 14 days); neutrophils count ≥1.5×10\^9/l; platelet count ≥80×10\^9/l; 7. biochemical tests: 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); 8. voluntarily signed the informed consent; 9. good compliance and family members are willing to cooperate with follow-up. exclusion criteria: 1. other uncured malignancies; 2. pregnant or lactating women, if the subject becomes pregnant during the study period, should withdraw from the clinical trial; 3. previous anti-tumor therapy for the disease in this study; 4. participated in other drug clinical trials within one month; 5. patients with known history of other systemic serious diseases before screening; 6. long-term unhealed wounds or incomplete healed fractures; 7. have a history of organ transplantation; 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; 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; 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; 12. concomitant diseases that, in the investigator's judgment, seriously endanger patient safety or affect patient completion of the study.