JPRN-UMIN000000574已完成3 期
Randomized phase III study of TS-1 alone versus TS-1 plus Lentinan(LNT) in advanced or recurrent gastric cancer (AGC)
Japanese Foundation for Multidisciplinary Treatment of Cancer0 个研究点目标入组 300 人开始时间: 2007年1月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
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
- •1) Histologically demonstrated adenocarcinoma of advanced or recurrent gastric carcinoma
- •2) If measurable lesions exist, these have to be evaluated within 28 days before registration
- •3) No prior therapy
- •4) Sufficient organ functions
- •5) Performance Status (ECOG scale) : 0-2
- •6) Expected survival over 3 months
- •7) Oral intake is possible
- •8) Written informed consent
排除标准
- •1) Limitation of use of TS-1 or Lentinan
- •2) Infection and inflammation
- •3) Serious heart disease
- •4) Serious coexisting illness
- •5) A large amount of pleural effusion or peritoneal fluid
- •6) Broad bone metastasis
- •7) Brain metastasis
- •8) Fresh bleeding from digestive organs
- •9) Diarrhea
- •10) Severe mental disorders
- •11) Active synchronous malignancy
- •12) Pregnant or nursing
- •13) Not suitable for participating in this study for any other reason
研究者
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