JPRN-UMIN000028677招募中2 期
Phase II study of FOLFIRI+Ramucirumab with early recurrent colorectal cancer refractory to adjuvant chemotherapy with oxaliplatin / fluoropyrimidine(RAINCLOUD) - RAINCLOUD
MCSGO: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group0 个研究点目标入组 48 人开始时间: 2017年8月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Has simultaneous or metachronous 2) Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders 3) Has an uncontrolled intercurrent illness 4) Has experienced any arterial thrombotic or arterial thromboembolic events 5) Receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted 6) Has known (currently or in the past) leptomeningeal disease or brain metastases or uncontrolled spinal cord compression 7) Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy 8) Either of HIV-1 antibody, HIV-2 antibody or HBs antigen is positive 9) The patient who is HBs antibody or HBc antibody positive and HBV-DNA positive 10) Has received a prior autologous or allogeneic organ or transplantation 11) Has undergone major surgery within 28 days prior to randomization or subcutaneous venous access device placement within 7 days prior to randomization 12) Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization 13) Has an elective or planned major surgery to be performed during the course of the trial 14) Has an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator 15) Has experienced a Grade 3 or higher bleeding event within 3 months prior to randomization 16) Has either peptic ulcer disease associated with a bleeding event, or known active diverticulitis 17) Has a known history or clinical evidence of Gilberts Syndrome, or is known to have any of the following genotypes: UGT1A1*6/*6, UGT1A1*6/*28, UGT1A1*28/*28 18) The patient desires to have children. 19) The patient whose participation is in the trial is inappropriate by the doctor
研究者
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