JPRN-UMIN000030077已完成2 期
Phase II study investigating efficacy and safety of TFTD plus bevacizumab by RAS mutation status in patients with unresectable advanced or recurrent colorectal cancer refractory or intolerant to standard chemotherapy - PhaseII study investigating efficacy and safety of TFTD plus bevacizumab by RAS mutation status in patients with unresectable advanced or recurrent colorectal cancer refractory or intolerant to standard chemotherapy (JFMC51-1702-C7)
Japanese Foundation for Multidisciplinary Treatment of Cancer0 个研究点目标入组 102 人开始时间: 2018年1月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
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.History of intolerance to bevacizumab 2.Thromboembolic events within the 6 months before enrolment 3.Active bleeding 4.Severe heart disease within the 6 months before enrolment 5.Cerebrovascular events 6.Active infections 7.Ascites, pleural effusion, or pericardial effusion requiring treatment 8.Gastrointestinal obstruction, renal failure, or liver failure 9.Uncontrolled diabetes mellitus 10.Uncontrolled hypertension 11.Positive for Hepatitis B surface antigen (HbsAg+) or Hepatitis C antibody (HCV Ab+) 12.Other active cancer 13.Symptomatic brain metastases 14.Requiring immunosuppressive treatment due to an autoimmune disorder or history of organ transplantation 15.Treatment history; (1)Major surgery (i.e., thoracotomy or laparotomy) within the 4 weeks before enrollment (2)Chemotherapy within the 2 weeks before enrollment (3)Extensive exposure of radiation within the 4 weeks before enrollment 16.Unresolved adverse events of grade 2 or higher (classified with the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) from previous treatment 17.Unhealed wound or traumatic fracture 18.tendency of haemorrhage and undergoing treatment with an antithrombotic drug (including a daily dose of 325 mg or more of oral aspirin) 19.Females who are in pregnancy, breastfeeding, with a positive pregnancy test or unwilling to use adequate contraception or males of reproductive potential 20.Clinically significant mental or psychological disorder 21.Patients whose participation in the trial was judged to be inappropriate by the investigator
研究者
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