JPRN-UMIN000007368已完成2 期
Phase II study of TS-1+Trastuzumab in HER2-positive advanced gastric cancer patients more than 65 years old - JACCRO GC-06
Japna Clinical Cancer Research Organizetion0 个研究点目标入组 40 人开始时间: 2012年2月23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
- 40
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
- 65years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Scond primary malignancy (except adequately treated basal cell carcinoma treated more than 5 years ago without recurrence) 2) Severe ascites and / or pleural effusion 3) Patients with brain metastasis 4) Patients with fresh bleeding from gastric cancer and / or the digestive tract 5) Patients with active infection (> 38C) 6) Patients have active hepatitis type B 7) Patients with a previous history of congestive heart failure 8) Unstable angina requiring medication 9) Patients with a previous history of transmural infarct 10) Uncontrolled hypertension 11) Severe heart valve diseases 12) Hi-risk uncontrolled arrhythmias 13) Serious complication as followings; interstitial pneumonia; pulmonary fibrosis; heartfailure; renal failure; hepatic failure; uncontrolled diabetes mellitus 14) Patients with resting dyspnea 15) Patients with diarrhea (4 or more times per day or watery diarrhea) 16) Patients who are contraindicated to TS-1 and Trastuzumab 17) Hypersensitivity to have a history TS-1 and / or Trastuzumab 18) Patients who are received systemic continuous admnistration of flucytosine. 19) Patients who are recieving systemic continuous administration of phenytoin or warfarin 20) Patients who are received systemic administration of corticosteroid for a long time or with high doses 21) Women in pregnancy, at risk of pregnancy, or hoping to become pregnant. Men who want their partners to become pregnant. 22) Any patinets judged by the investigator to be unfit to perticipate in the study
研究者
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