Sequential or Up-front Triple Treatment With Durvalumab, Tremelimumab and Bevacizumab for Non-resectable Hepatocellular Carcinoma (HCC) Patients (MONTBLANC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 83
- 试验地点
- 5
- 主要终点
- ORR
研究概览
简要总结
This is a randomized, open-label, multi-center, international, Phase II study to assess the efficacy and safety of sequential or up-front triple treatment with durvalumab, tremelimumab and bevacizumab for non-resectable hepatocellular carcinoma.
Patients will be randomized in a 1:1 ratio to one of the following arms:
Arm A: initial treatment with durvalumab plus tremelimumab followed by treatment escalation with the addition of bevacizumab upon radiological progression or in the absence of objective response
Arm B: up-front treatment with durvalumab, tremelimumab and bevacizumab
Patients will be stratified according to macrovascular invasion and etiology of liver disease (viral etiologies versus others).
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 —（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
结局指标
主要结局
ORR
时间窗: 24 months
overall response rate
次要结局
- PFS(24 months)
- mOS(24 months)
- TTP(24 months)
- ORR-BICR(24 months)
研究者
Enrico De Toni
Prof. Dr. Enrico De Toni
Ludwig-Maximilians - University of Munich