NCT04979663Unknown1 期
Safety and Efficacy of GEMOX Combined With Donafenib and Tislelizumab as First-line Treatment in Biliary Tract Cancer
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety: the incidence of adverse events and serious adverse events
研究概览
简要总结
Study design: Prospective, single-arm, single-center study; Primary endpoint: Safety; Secondary endpoints: Disease control rate, overall response rate, conversion rate, overall survival; Main characteristics of enrolled patients: Patients with initially unresectable biliary tract cancer; Interventions: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab; Sample size: 10 patients;
Treatment until:
- successfully conversed to resectable disease
- progressed disease
- intolerable toxicity
- patient requests withdrawal Research process: In this study, patients who met the inclusion criteria were evaluated at the end of every 2 circles of treatment (6 weeks), 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 years and ≤80 years;
- •ECOG physical condition score: 0~1;
- •Histologically or cytologically confirmed malignant tumor of epithelial origin in the biliary system;
- •Preoperative imaging assessment of the disease stage was III/IV;
- •The main organs function well, and the examination indicators meet the following requirements:
- •Routine blood tests: Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophil count ≥1.5×10^9/L; Platelet count ≥80×10^9/L; Biochemical examination: Total bilirubin ≤2×ULN (upper normal value); ALT or AST ≤ 2.5×ULN; Endogenous creatinine clearance ≥ 50 mL /min (Cockcroft-Gault formula);
- •Sign the informed consent voluntarily;
- •Good compliance, and family members willing to cooperate with follow-up.
排除标准
- •Patients with other uncured malignant tumors;
- •Pregnant or lactating women who are required to withdraw from the clinical trial if they become pregnant during the study period;
- •Previous antitumor therapy for the disease in this study;
- •Participated in clinical trials of other drugs within one month;
- •Patients with a known history of other systemic serious diseases before screening;
- •Long-term unhealed wounds or incomplete healing fractures;
- •Previous organ transplantation history;
- •Abnormal coagulation function;
- •Screening for overactivity/venous thrombosis events in the previous year, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
- •Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders;
- •A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- •Concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.
结局指标
主要结局
Safety: the incidence of adverse events and serious adverse events
时间窗: 3 weeks
Incidence of adverse events and serious adverse events
次要结局
- Conversion rate(6 weeks)
- Overall survival(6 weeks)
- Overall response rate(6 weeks)
- Disease control rate(6 weeks)
研究者
Lu Wang, MD, PhD
Head of liver surgery department
Fudan University
研究点 (1)
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