Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer : A Multicenter, Randomized, Controlled and Prospective Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- time to progression(TTP)
研究概览
简要总结
Recent clinical studies have demonstrated a reduction of irinotecan (CPT-11) gastrointestinal toxicities when the CPT-11 is administered in combination with thalidomide in patients with diagnosis of gastric cancer. The main purpose of this study is to investigate the efficacy and safety of thalidomide and CPT-11 in advanced gastric cancer. The investigators will also manage to find out the possible interactions between CPT-11 pharmacokinetics and thalidomide to explain the previously described gastrointestinal toxicity reduction.
详细描述
This is a prospective, randomized, multi-center, controlled clinical trial, aimed to evaluate efficacy and tolerability of thalidomide and CPT-11 in advanced gastric cancer. A total of 900 patients are planned to be enrolled into the study. Patients with diagnosis of advanced gastric cancer will be randomized into two groups, and be treated with thalidomide+ CPT-11 or CPT-11, respectively. The primary end point is time to progression (TTP), and the secondary end points include efficacy, overall survival (OS) and the occurrence of delayed diarrhea.
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
- •18y <Age<75y
- •Patients with histologically proven tumor focus will be eligible for this protocol
- •Measurable or assessable disease
- •At least 4 weeks since last chemotherapy ;chemotherapy regimens without Irinotecan
- •No hepatic, renal and hematopoietic dysfunction; no hemorrhage of digestive tract,obstructive jaundice, gastrointestinal perforation or obstruction
- •ECOG PS:0-2
- •Expected OS ≥ 3 months
排除标准
- •obstruction of digestive tract, thrombosis or other intolerant side effects during treatment
研究组 & 干预措施
Arm A (thalidomide+CPT-11)
Patients will receive CPT-11 180 mg/m^2 ivgtt ,over 90 minutes on day 1, every 21 days for one cycle, four cycles ,and oral thalidomide 100 mg/d qn. Maintenance therapy with thalidomide in the same dose is performed until disease progression.
干预措施: Thalidomide (Drug)
Arm A (thalidomide+CPT-11)
Patients will receive CPT-11 180 mg/m^2 ivgtt ,over 90 minutes on day 1, every 21 days for one cycle, four cycles ,and oral thalidomide 100 mg/d qn. Maintenance therapy with thalidomide in the same dose is performed until disease progression.
干预措施: CPT-11 (Drug)
Arm B (CPT-11)
Patients will receive CPT-11 180 mg/m^2 ivgtt ,over 90 minutes on day 1, every 21 days for one cycle, four cycles.
干预措施: CPT-11 (Drug)
结局指标
主要结局
time to progression(TTP)
时间窗: up to 2 months
次要结局
- complete response rate (CRR) for advanced gastric cancer(up to 2 months)
- overall survival (OS)(up to 2 months)
研究者
Wang Jufeng
Master
Zhengzhou University