A Phase II Clinical Trial of Prior Regimen Rechallenge in Third or Later-line Chemotherapy for Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This is a single-arm, open-label, single-center prospective phase II study to evaluate the efficacy and safety of rechallenge chemotherapy in the third or later-line treatment in patients with advanced colorectal cancer. The primary end point is progression free survival (PFS). A total of 42 patients who failed with oxaliplatin, irinotecan and fluorouracil in previous treatment and could not receive the target therapy presently are planned for recruitment. For patients with metastatic colorectal cancer who met admission criteria, oxaliplatin- or irinotecan-based chemo regimen could be used and evaluation was repeated every 6 weeks. The treatment continues until the disease progression or the untolerable adverse reaction.
详细描述
The treatment for reintroduction was oxaliplatin- or irinotecan-based chemo-regimen.
Optional chemotherapy regimen included XELOX,FOLFOX,FOLFIRI,Irinotecan single-agent
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
The rechallenge regimens
XELOX ± BEV, repeating every 3 weeks.
FOLFOX ± BEV, repeating every 2 week
FOLFOX ± Cetuximab, repeating every 2 week
FOLFIRI ± BEV, repeating every 2 weeks.
FOLFIRI ± Cetuximab, repeating every 2 weeks.
IRI ± BEV, repeating every 2 weeks.
IRI ± Cetuximab, repeating every 2 weeks.
Raltitrexed ± BEV, repeating every 3 weeks.
Raltitrexed ± Cetuximab, repeating every 2 weeks.
干预措施: the rechallenge regimen (Drug)
结局指标
主要结局
PFS
时间窗: from the time signing of informed consent form(ICF) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
progression free survival
次要结局
- OS(from the time signing of ICF until the date of death from any cause, assessed up to 48 months)
研究者
Weijian Guo
Vice director of Dep.Medical Oncology, Fudan University Shanghai Cancer Center
Fudan University
