JPRN-UMIN000008254招募中2 期
A randomized phase II study investigating an optimal dosing regimen of TS-1 plus CDDP plus Trastuzumab combination therapy for HER2-positive unresectable and/or recurrent gastric cancer - Phase II study of TS-1 plus CDDP plus Trastuzumab combination therapy for HER2-positive unresectable and/or recurrent gastric cancer
Juntendo University School of Medicine Department of Gastroenterology0 个研究点目标入组 40 人开始时间: 2012年6月25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
- 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
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Subjects with synchronous double cancer or metachronous double cancer with a disease-free interval of less than five years(In-situ cancer, gastric cancer, mucosal cancer, differentiated adenocarcinoma, and skin cancer judged to be cured by treatment are not considered to be active double cancers.) 2)Subjects with a previous history of serious drug hypersensitivity 3)Subjects requiring continuous use of flucytosine, phenytoin, and/or warfarin potassium 4)Subjects being treated with pyrimidine fluoride antineoplastic agents other than TS-1(including any combination therapy) 5)Subjects with infectious diseases associated with a fever of 38.0 degrees C or higher 6)Subjects shown to be HBs antigen positive 7)Subjects with serious complications (interstitial pneumonia or pulmonary fibrosis, difficult-to-control diabetes, renal failure, hepatic failure, cardiac failure, bone-marrow suppression, and so on) 8)Subjects with diarrhea (more than four times daily or watery stool) 9)Subjects with accumulation of pleural and ascitic fluids requiring paracentesis for symptom relief 10)Subjects with the following cardiac diseases or conditions Previous history of congestive cardiac failure Angina pectoris requiring drug treatment Obvious transmural myocardial infarction on electrocardiograph Clinically-evident cardiac valvular disease Poorly-controlled hypertension (systolic BP>180mmHg and/or diastolic BP>100mmHg) High-risk uncontrolled arrhythmias A previous history of myocardial infarction Ischemic cardiac disease requiring treatment 11)Women of child-bearing potential (intention), pregnant or lactating women 12)Men desiring to have children 13)Subjects with a previous history of serious psychiatric diseases or being treated for such diseases and judged to be ineligible for participating in the study 14)Subjects judged by the investigator(s) to be inappropriate study participants for any other reason
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