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临床试验/NCT03485027
NCT03485027已完成2 期

A Phase II Clinical Trial of Prior Regimen Rechallenge in Third or Later-line Chemotherapy for Patients With Metastatic Colorectal Cancer

Fudan University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2018年1月24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
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

The rechallenge regimens

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Weijian Guo

Vice director of Dep.Medical Oncology, Fudan University Shanghai Cancer Center

Fudan University

研究点 (1)

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