NCT04832776招募中2 期
FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
To compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG perfomance 0-1
- •pathologically confirmed colorectal carcinoma, with RAS wild type
- •inital unresectable liver metastases discussed by MDT
- •prior no systemical therapy or exceed 6 months after the adjuvant chemotherapy of primary tumor surgery.
- •without extraheptic metastatic lesions, except for locally controlled lung metastases (RFA or SBRT)
- •adequate blood, liver and renal function
- •expected survival longer than 6 months
排除标准
- •with bleeding risk
- •interestinal obstruction or disease
- •uncontrolled hypertension and severe heart disease
- •previous severe thrombotic events
- •central nervous system metastases
- •accompanied with other malignant tumor
研究组 & 干预措施
FOLFOXIRI+C225
Experimental
干预措施: Cetuximab (Drug)
FOLFOXIRI+C225
Experimental
干预措施: FOLFOXIRI (Drug)
FOLFOXIRI+BEV
Active Comparator
干预措施: Bevacizumab (Drug)
FOLFOXIRI+BEV
Active Comparator
干预措施: FOLFOXIRI (Drug)
结局指标
主要结局
ORR
时间窗: up to 8 weeks
objective response rate
次要结局
- OS(up to 6 months)
- R0 resection rate of liver metastases(up to 8 weeks)
- NED rate(up to 8 weeks)
- PFS(up to 8 weeks)
研究者
Sanjun Cai
Department of Colorectal Surgery
Fudan University
研究点 (1)
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