JPRN-UMIN000017114已完成1 期
Multicenter Phase 1b/2 Trial of Nintedanib with TAS-102 in Patients with Metastatic Colorectal Cancer (mCRC) who had the progression or intolerant to standard therapies. - N-TASK FORCE
ational Cancer Center0 个研究点目标入组 55 人开始时间: 2015年4月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
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)Serious coexisting illness as follows. a. Active double cancer(s) b. CNS metastasis c. Uncontrollable infectious disease d. Uncontrollable pleural effusion, ascites, or cardiac effusion e. Ileus, interstitial pneumonia,renal failure, hepatic failure or cerebrovascular disorder f. Uncontrolled diabetic g. Uncontrolled hypertension h. Cardiac infarction, serious angina or New York Heart Association Class III or IV within 6 months prior to the registration i Gastrointestinal bleeding j Positive HBs antigen, HCV antibody or HIV antibody k. Need immunosuppressive therapy l. Uncontrolled mental disease or the psychotic manifestation 2)Receive the treatment as follows. a.Major surgery therapy within 4 weeks prior to enrollment. b.Chemotherapy within 3 weeks prior to enrollment. c. Wide field radiotherapy 4 weeks prior to enrollment or local radiotherapy 2 weeks prior to enrollment. d.Other investigational drugs within 4 weeks prior to enrollment. 3)Prior treatment with TAS-102 or Nintedanib 4)Unrecovered AEs related to prior treatment are Grade >= 2 according to CTCAE. 5)Blood transfusion or G-CSF within 14 days prior to enrollment. 6)Serious renal failure or proteinuria >= 2+ within 7days prior to enrollment. 7)Thromboembolic event or serious Pulmonary complaints within one year 8)Uncomplete cure wound or traumatic fracture 9)Tendency to hemorrhages or taking antithrombotic medication 10) Women during pregnancy or lactation , 11) Patient is judged by the investigator to be inappropriate for study participation for any reason.
研究者
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