NCT03084757已完成不适用
SHIVA02 - Evaluation of the Efficacy of Targeted Therapy Based on Tumor Molecular Profiling in Patients With Advanced Cancer Using Each Patient as Its Own Control
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 8
- 主要终点
- Proportion of patients with a PFS2 to PFS1 ratio superior to 1.5.
研究概览
简要总结
The study will evaluate the efficacy of targeted therapy based on tumor molecular profiling versus conventional chemotherapy in patients with advanced cancer using each patient as its own control. This study is a study involving patients with advanced cancer. All types of solid tumors will be allowed in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
research of druggable molecular alterations on tumor biopsy
Experimental
干预措施: research of druggable molecular alterations on tumor biopsy (Diagnostic Test)
结局指标
主要结局
Proportion of patients with a PFS2 to PFS1 ratio superior to 1.5.
时间窗: 3 years
PFS1 is defined as the time to a documented progression under conventional therapy according to RECIST 1.1. PFS2 is defined as the time to a documented progression or death when patients are treated by targeted therapy according to RECIST 1.1
次要结局
- Overall survival (OS)(3 years)
- Ability of fine-needle aspiration cytology to detect molecular alterations identified on tumor biopsies(at baseline)
- Overall response rate (ORR) on both treatments(3 years)
- number of grade 3 or 4 adverse events and grade 1 or 2 adverse events that lead to dose modification or interruption(3 years)
- Ability of ctDNA to detect molecular alterations identified on tumor biopsies(at baseline)
- Proportion of patients with a PFS2 to PFS1 ratio superior to 1.5, including patients who were treated with matched therapy based on a molecular alteration outside of RAF/MEK pathway(3 years)
- Ability of sequential ctDNA sampling to predict response/resistance to treatment(through study completion, every 2 months)
研究者
研究点 (8)
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