NCT01926769终止2 期
A Phase II Study to Determine the Safety and Efficacy of Second-line Treatment With Metformin and Chemotherapy (FOLFOX6 or FOFIRI) in the Second Line Threatment of Advanced Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Disease Control Rate
研究概览
简要总结
To determine the safety and efficacy of second-line treatment with Metformin and Chemotherapy (FOLFOX6 or FOFIRI) in the second line treatment of advanced colorectal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18
- •histologically confirmted advanced colorectal cancer
- •ECOG PS 0-2
- •expected life span more than 3months
- •normal bone marrow, liver, renal function
排除标准
- •5-FU, oxaliplatin, irinotecan or Metformin Allergic history
- •Lactic acidosis, metabolic acidosis
- •active infection or severe neuropathy
研究组 & 干预措施
FOLFOX6+Metformin/FOFIRI+Metformin
Experimental
干预措施: Metformin (Drug)
结局指标
主要结局
Disease Control Rate
时间窗: one year
次要结局
- Response Rate(one year)
- Overall Survival(one year)
- Number of participants with adverse events(one year)
- Progression Free Survival(one year)
研究者
Hee Kyung Ahn
Assistant Professor
Gachon University Gil Medical Center
研究点 (1)
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