NCT04224636招募中2 期
A Randomized, 2-arm Non-comparative Phase II Study on the Efficacy of Atezolizumab and Roche Bevacizumab (Atezo/Bev) Followed by On-demand Selective TACE (sdTACE) Upon Detection of Disease Progression or of Initial Synchronous Treatment With TACE and Atezo/Bev on 24-months Survival Rate in the Treatment of Unresectable Hepatocellular Carcinoma Patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 12
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
Aim of the study is to evaluate the efficacy of up-front atezolizumab/ bevacizumab (Atezo/Bev) followed by on-demand selective transarterial chemoembolization (sdTACE) and of initial synchronous treatment with TACE and Atezo/Bev in the treatment of unresectable HCC patients.
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
Overall response rate (ORR)
时间窗: 24 months
Response is defined by RECIST 1.1 and mRECIST
次要结局
- Adverse Events(24 months)
- Median overall survival (mOS)(24 months)
- 24-months survival rate(24 months)
- Time to deterioration of liver function(24 months)
- Disease control rate (DCR)(24 months)
- Time to first TACE (arm A)(24 months)
- Time to untreatable progression(24 months)
- Time to stage-progression(24 months)
- Complete response rate (CRR)(24 months)
- Progression-free survival (PFS)(24 months)
- Quality of life (QOL)(24 months)
研究者
Enrico De Toni
Professor
Ludwig-Maximilians - University of Munich
研究点 (12)
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