VIC Regimen (Vemurafenib/Irinotecan/Cetuximab) Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
In this study, we compared first-line VIC regimen with chemotherapy plus bevacizumab in Chinese patients with initially unresectable BRAF V600E-mutated mCRC. The principal goal was to evaluate the safety of VIC regimen, and to investigate the tumor response, the radical resectability, and the patient survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤80 years old
- •Histologically confirmed colorectal adenocarcinoma
- •Histologically confirmed BRAFV600E mutated and RAS wild-type
- •Initially unresectable metastatic or local CRC
- •ECOG performance status of 0-1 and life expectancy ≥3 months
- •adequate hepatic, renal, and hematologic function
排除标准
- •Previously taken any targeted therapy, chemotherapy, intervention therapy, or radiotherapy for CRC within 6 months
- •Other cancers (with the exception of cervical cancer in situ and squamous cell carcinoma of the skin) within the previous 5 years.
研究组 & 干预措施
VIC
VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)
干预措施: VIC (Drug)
BEV
Bevacizumab Plus Chemotherapy
干预措施: Bevacizumab Plus Chemotherapy (Drug)
结局指标
主要结局
overall survival
时间窗: 3 years
time from first study treatment to death from any cause.
progression-free survival
时间窗: 3 years
time from first study treatment to the first documented progression disease or death, whichever occurred first
objective response rate
时间窗: 6 months
the proportion of patients with complete response or partial response.
次要结局
未报告次要终点
研究者
Xu jianmin
Deputy director of the department of general surgery
Fudan University