jRCTs041230120招募中不适用
A pragmatic, randomized phase III trial of bi-weekly versus conventional schedule of TAS-102 plus bevacizumab for metastatic colorectal cancer (PRABITAS)
未提供0 个研究点目标入组 890 人开始时间: 2023年12月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 890
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Histopathologically diagnosed as adenocarcinoma of the colon.
- •Diagnosed as metastatic colorectal cancer.
- •Age 18 years or older on the date of consent.
- •ECOG PS of 0-
- •Confirmed RAS gene status by tumor tissue.
- •Received all fluoropyrimidines, oxaliplatin, irinotecan and molecular targeted agents.
- •No previous administration of FTD/TPI.
- •Ability to safely receive the protocol treatment.
- •Written informed consent obtained from the patient.
排除标准
- •History of severe hypersensitivity reactions to components of FTD/TPI or BEV.
- •Pregnant or potentially pregnant women.
- •History of hemoptysis (more than 2.5 ml of fresh blood)
- •Judged ineligible for trial participation by the investigator.
结局指标
主要结局
-
Overall survival:OS
次要结局
- Progression free survival
- Response rate
- Disease control rate
- Time to treatment failure
研究者
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