GAMBIT Trial: A Randomized,Non-comparative, Open-label Clinical Trial Evaluating Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
To evaluate safety and efficacy of the combination cisplatin plus irinotecan in the treatment of biliary tract cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •biopsy-proven gallbladder or biliary tract cancer;
- •Recurrent, metastatic or unresectable disease;
- •Chemo-naïve.
- •Not candidates to curative-intent treatment, such as surgery or radiation-therapy;
- •Measurable disease according to RECIST 1.1;
- •ECOG 0-2;
- •Adequate hematologic and biochemistry tests;
- •Creatinine clearance >= 60ml/min.
排除标准
- •Known hypersensibility or previous therapy with cisplatin, gemcitabine or irinotecan;
- •Chronic immunosuppressive therapy;
- •Known CNS metastasis;
- •Previous diagnosis of other cancer;
- •Chronic or acute active infection, except asymptomatic HIV infection;
- •Active bleeding;
- •Any severe medical condition;
- •Pregnant or lactating women, or with childbearing potential;
研究组 & 干预措施
IP (irinotecan and cisplatin)
Irinotecan 65mg/m² D1 and D8 q21 days plus Cisplatin 60mg/m² D1 q 21 days, until disease progression or unacceptable toxicity, with standard hydration and antiemetics.
干预措施: Irinotecan (Drug)
IP (irinotecan and cisplatin)
Irinotecan 65mg/m² D1 and D8 q21 days plus Cisplatin 60mg/m² D1 q 21 days, until disease progression or unacceptable toxicity, with standard hydration and antiemetics.
干预措施: Cisplatin (Drug)
GC (gemcitabine and cisplatin)
Gemcitabine 1000mg/m² D1 and D8 every 21 days plus cisplatin 25mg/m² D1 and D8 every 21 days, until disease progression or unacceptable toxicity, with standard hydration and antiemetics.
干预措施: Cisplatin (Drug)
GC (gemcitabine and cisplatin)
Gemcitabine 1000mg/m² D1 and D8 every 21 days plus cisplatin 25mg/m² D1 and D8 every 21 days, until disease progression or unacceptable toxicity, with standard hydration and antiemetics.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Up to 24 weeks from randomization
The overall response rate will measure the number of subjects with complete or partial response as best response during the entire treatment, over the total number of subjects, for each arm. The response will be evaluated according to RECIST 1.1.
次要结局
- Overall Survival (OS)(6mo after the last enrolled patient)
- Disease Control Rate(Up to 6 weeks from randomization)
- Safety(6 mo after the last enrolled patients)
- Progression-Free Survival (PFS)(6mo after the last enrolled patient)