NCT02558959已完成2 期
Effect of Second-line Irinotecan and Capecitabine Versus Irinotecan Alone in Advanced Biliary Tract Cancer Patients Progressed After First-line Gemcitabine and Cisplatin: A Randomized Controlled Study
Zhejiang University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2015年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This study is designed to investigate the effect of second-line irinotecan and capecitabine versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract cancer patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed advanced biliary tract cancer who had experienced progression during first-line gemcitabine and cisplatin
- •Age 18 years or older
- •Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
- •Karnofsky performance status (KPS) of at least 70%
- •Adequate renal function, adequate hepatic function, adequate bone marrow function
排除标准
- •The presence of any severe concomitant disease that could interrupt the planned treatment
- •Intractable pain
- •Hypersensitivity to study drugs
- •Serious cardiovascular disease
- •If female, pregnancy or breastfeeding
研究组 & 干预措施
Irinotecan and Capecitabine
Experimental
irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w
干预措施: Irinotecan (Drug)
Irinotecan and Capecitabine
Experimental
irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w
干预措施: Capecitabine (Drug)
Irinotecan
Active Comparator
irinotecan 180mg/m2 d1, q2w
干预措施: Irinotecan (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: within 1 year
PFS
次要结局
- Overall Survival(within 1 year)
研究者
Weijia Fang
Director of Cancer Biotherapy Center
Zhejiang University
研究点 (1)
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