jRCTs061180008招募中不适用
Intraperitoneal and intravenous paclitaxel plus S-1 in patients with gastric cancer with peritoneal metastasis (Intraperitoneal and intravenous paclitaxel plus S-1 in patients with gastric cancer with peritoneal metastasis)
未提供0 个研究点目标入组 50 人开始时间: 2017年5月19日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 85age old not（—）
- 性别
- All
入选标准
- •histologically proven primar gastric adenocarcinoma.
- •Peritneal metastasis and/or cancer cells on peritoneal cytology.
- •Patients with following adequate function of important organs at screening period.
- •Neutrocyte >= 1,000/mm3
- •Hemoglobin >= 8.0g/dl
- •Platelet >= 75,000/mm3
- •AST, ALT < 150U/L
- •Total Bilirubin <= 3.0mg/dL
- •Creatinine clearance >= 30ml/min
- •Eastern Cooperative Oncology Group performance status 0-2
- •Age >= 20, < 85 years
- •Written informed consent.
排除标准
- •The absence of metastasis to distant organ sites except the retroperitoneum, ovary and abdominal lymph nodes.
- •Contraindication to S-1 or paclitaxel.
- •Apparent infection or inflammation.
- •Sever heart disease.
- •Sever complication.
- •Gastrointestinal bleeding requiring blood transfusion repeatedly.
- •Pregnancy, breast feeding or intention to become pregnant.
- •Inappropriate for this trial for other reasons.
结局指标
主要结局
-
Safety(Adverse experience. Laboratory tests. Vital sign)
次要结局
未报告次要终点
研究者
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