JPRN-jRCT1080223562已完成2 期
A randomized phase 2/3 study of fluoropyrimidine and irinotecan plus bevacizumab versus trifluridine/tipiracil plus bevacizumab as second-line treatment in patients with metastatic colorectal cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 524
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) A histopathologically or cytologically confirmed diagnosis of curatively unresectable advanced adenocarcinoma of the colon or rectum for which RAS mutation status has been confirmed on RAS mutation analysis
- •(2) Curatively unresectable advanced adenocarcinoma of the colon or rectum with no response to first-line treatment with a fluoropyrimidine (5-FU/l-LV, capecitabine, TS-1) + oxaliplatin combined with bevacizumab or an anti-EGFR antibody (cetuximab or panitumumab: only RAS wild-type tumors)
- •(3) An age of at least 20 years at the time of registration
- •(4) An ECOG performance status of 0 or 1
- •(5) Possible to orally administer drugs
- •(6) Lesions assessable on CT, MRI, etc. confirmed within 28 days before registration (measurable lesions not required)
- •(7) Main organ functions maintained on examinations performed within 7 days before registration
- •(8) Written informed consent to participate in the study obtained directly from the patient
排除标准
- 未提供
研究者
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