A Phase II, Multicenter, Open-Label, Randomized, Controlled Study to Assess Efficacy and Safety of Cetuximab in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Cisplatin Alone for the First-line Treatment of Chinese Subjects With Metastatic Esophageal Squamous Cell Carcinoma.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This is an open-label, randomized, controlled trial. At the end of a 28-day screening period, all eligible subjects will be randomly assigned into treatment Arm A or B in a 1:1 ratio. Subjects in Arm A will receive a maximum of 6 cycles of chemotherapy (cisplatin plus paclitaxel) and cetuximab weekly in the absence of progressive disease (PD), as assessed by the Investigator, and unacceptable toxicity. After 6 cycles of treatment, subjects who derive clinical benefit will continue treatment with cetuximab as monotherapy until either PD or unacceptable toxicity. Subjects in Arm B will receive the same chemotherapy regimen as Arm A alone for a maximum of 6 cycles in the absence of PD and unacceptable toxicity.
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
- •Signed written informed consent.
- •Older than 18 years of age.
- •Histologically proven squamous cell carcinoma of the esophagus.
- •Metastatic ESCC, not suitable for local-regional treatment.
- •Presence of at least 1 measurable lesion according to RECIST version 1.
- •ECOG performance status of 0 or
- •Adequate bone marrow, haptic, renal, metabolic function.
排除标准
- •Prior chemotherapy in the metastasis setting.
- •Prior chemotherapy within 6 months before entering this study.
- •Previous exposure to EGFR-targeted therapy.
- •Known central nervous system metastasis and/or leptomeningeal disease.
- •Subjects with any concurrent medical condition or disease that will potentially compromise the conduct of the trial at the discretion of investigator.
研究组 & 干预措施
chemotherapy (cisplatin plus paclitaxel) and cetuximab
干预措施: cetuximab (Drug)
chemotherapy (cisplatin plus paclitaxel) and cetuximab
干预措施: cisplatin plus paclitaxel (Drug)
chemotherapy (cisplatin plus paclitaxel)
干预措施: cisplatin plus paclitaxel (Drug)
结局指标
主要结局
Progression free survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
次要结局
- Overall Survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- overall response rate(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Disease control rate(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
研究者
Shen Lin
Director,Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
Peking University