JPRN-jRCTs041180166进行中（未招募）2 期
Randomized phase II study of FOLFIRI plus ramucirumab versus FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer (WJOG9216G) - WJOG9216G, RECAST
Kito Yosuke0 个研究点目标入组 120 人开始时间: 2019年3月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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 <= 75age old（—）
- 性别
- All
入选标准
- •1) Histologically or cytologically diagnosed adenocarcinoma of the colon or rectum (excluding the appendix and anal canal).
- •2) Tumor is clinically determined to be unresectable for a radical cure.
- •3) Age of 20-75 years.
- •4) ECOG PS of 0-1 (a PS 0 is required for subjects aged 71-75 years).
- •5) Measurable lesion according to RECIST, version 1.1.
- •6) No history of chemotherapy (however, subjects may register if they have received adjuvant chemotherapy with fluoropyrimidine monotherapy and the cancer recurrence occurred > 24 weeks after the last dose. Patients who have received OX-based adjuvant chemotherapy may not register.)
- •7. Retained organ function.
- •8. UGT1A1 gene status of wild type (*1/*1), or *28, *6 genetic polymorphism single hetero-type (*1/*28, *1/*6).
- •9. The RAS mutation status (wild-type, mutant or not definable) of the patients is known prior to randomization.
排除标准
- •1) Serious complications.
- •2) Receipt of a blood transfusion or hematopoietic factor therapy within 2 weeks prior to registration.
- •3) Grade 2 or worse peripheral sensory neuropathy.
- •4) History of Grade 3 or worse thromboembolism within 6 months before the scheduled treatment start date.
- •5) Receiving anti-platelet agents. Aspirin use at doses up to 325 mg/day is permitted.
- •6) Women who are pregnant, breastfeeding, had a positive pregnancy test, or women and men who do not wish to use contraception.
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