Efficacy and Safety of the Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Initially Unresectable Biliary Tract Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤80 years;
- •Histologically or cytologically confirmed carcinoma of the bile duct or gallbladder;
- •Imaging assessment of disease stage III/IVA/any TN1M0*;
- •The main organs have good functions and the examination indexes meet the following requirements:
- •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;
- •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);
- •Voluntarily signed the informed consent;
- •Good compliance and family members are willing to cooperate with follow-up.
排除标准
- •Other uncured malignancies;
- •Pregnant or lactating women, if the subject becomes pregnant during the study period, should withdraw from the clinical trial;
- •Previous anti-tumor therapy for the disease in this study;
- •Participated in other drug clinical trials within one month;
- •Patients with known history of other systemic serious diseases before screening;
- •Long-term unhealed wounds or incomplete healed fractures;
- •Have a history of organ transplantation;
- •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;
- •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;
- •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;
- •Concomitant diseases that, in the Investigator's judgment, seriously endanger patient safety or affect patient completion of the study.
研究组 & 干预措施
combined treatment group
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab Gemcitabine: 1000mg/m^2, iv, d1, d8, q3w Oxaliplatin: 100mg/m^2, iv, d1, q3w Sintilimab: 200mg, iv, d1, q3w Bevacizumab: 5mg/kg, d1, q3w
干预措施: Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab (Drug)
结局指标
主要结局
objective response rate
时间窗: 3 weeks
objective response rate
次要结局
- Safety：the incidence of adverse events and serious adverse events(3 weeks)
- disease control rate(3 weeks)
- progress-free survival(3 weeks)
- overall survival(3 weeks)
研究者
Lu Wang, MD, PhD
Head of liver surgery department
Fudan University