NCT02558868已完成2 期
Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Advanced Pancreatic Cancer Patients Progressed After First-line Gemcitabine and S-1: A Randomized Controlled Study
Zhejiang University1 个研究点 分布在 1 个国家目标入组 80 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
- 80
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This study is a randomized, open-label, controlled study that will compare the efficacy of oxaliplatin in combination with irinotecan to irinotecan alone as second-line treatment for patients with gemcitabine and S-1 refractory pancreatic 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 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 pancreatic cancer who had experienced progression during first-line gemcitabine and S-1 were eligible for enrollment on this open-label, randomized study.
- •Additional inclusion criteria were 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 (eg, unstable coronary artery disease or myocardial infarction within 4 weeks of study start)
- •National Cancer Institute CommonToxicity Criteria grade 3 or 4 sensory or motor neuropathy
- •Prior or concurrent malignancy (other than pancreatic cancer)
- •Female, pregnancy or breastfeeding.
研究组 & 干预措施
Oxaliplatin + Irinotecan
Experimental
Irinotecan：160 mg/m2，iv 120 min，d1 q2w oxaliplatin: 85 mg/m2，iv 120 min，d1 q2w
干预措施: Irinotecan (Drug)
Oxaliplatin + Irinotecan
Experimental
Irinotecan：160 mg/m2，iv 120 min，d1 q2w oxaliplatin: 85 mg/m2，iv 120 min，d1 q2w
干预措施: Oxaliplatin (Drug)
Irinotecan
Active Comparator
Irinotecan：180 mg/m2，iv 120 min，d1 q2w
干预措施: Irinotecan (Drug)
结局指标
主要结局
Overall Survival
时间窗: 1 years
次要结局
- Progression Free Survival(1 years)
研究者
Weijia Fang
Director
Zhejiang University
研究点 (1)
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