NCT01757366Unknown2 期
Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer
Hebei Tumor Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Safety and Efficacy of Ginsenoside Rg3 in Combination with First-line Chemotherapy in Advanced Gastric Cancer.The purpose of this study is to assess the safety of Ginsenoside Rg3 in advanced gastric cancer, and whether it improves the efficacy of first-line chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form
- •Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
- •Histologically or cytologically confirmed gastric cancer;
- •At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
- •Life expectancy of at least 3 months;
排除标准
- •Received any prior treatment including Ginsenoside Rg3;
- •Active or uncontrolled infection;
- •Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
- •Pregnant or lactating women.
研究组 & 干预措施
experimental
Experimental
Ginsenoside Rg3 plus First-line Chemotherapy
干预措施: Ginsenoside Rg3 plus First-line Chemotherapy (Drug)
Active Comparator
Active Comparator
First-line Chemotherapy
干预措施: First-line Chemotherapy (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 1 years
次要结局
- Objective Response Rate (ORR)(1 year)
- Overall Survival (OS)(3 year)
研究者
研究点 (1)
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