An Exploratory Study to Evaluate Biomarkers as Predictive and /or Prognostic Factors of Benefit From Randomized Phase ll Study of mFOLFOX6+Bevacizumab or mFOLFOX6+Cetuximab in Liver Only Metastasis From KRAS Wild Type Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS)
研究概览
简要总结
The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.
详细描述
The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.
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
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who registered the ATOM trial and signed informed consent prior to initiation of any trial-specific procedure and treatment.
排除标准
- 未提供
研究组 & 干预措施
mFOLFOX + Bmab
mFOLFOX plus bevacizumab
干预措施: Bevacizumab (Drug)
mFOLFOX + Bmab
mFOLFOX plus bevacizumab
干预措施: L-OHP (Drug)
mFOLFOX + Bmab
mFOLFOX plus bevacizumab
干预措施: l-LV (Drug)
mFOLFOX + Bmab
mFOLFOX plus bevacizumab
干预措施: 5-FU (Drug)
mFOLFOX + Cmab
mFOLFOX plus cetuximab
干预措施: Cetuximab (Drug)
mFOLFOX + Cmab
mFOLFOX plus cetuximab
干预措施: L-OHP (Drug)
mFOLFOX + Cmab
mFOLFOX plus cetuximab
干预措施: l-LV (Drug)
mFOLFOX + Cmab
mFOLFOX plus cetuximab
干预措施: 5-FU (Drug)
结局指标
主要结局
To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS)
时间窗: Baseline, Cycle 8, Progression Disease
To evaluate the values of angiogenesis-related growth factors in plasma with PFS centrally assessed
次要结局
- Progression-free survival among the RAS wild type subpopulation(assessed every 8 weeks, up to 4 years)
- Exploratory analysis of the relevance of tumor size and expression level of angiogenesis-related growth factors in plasma(Baseline, Cycle 8, Progression Disease)
- To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events(Baseline, Cycle 8, Progression Disease)