A Phase III, Open-Label, Randomized Study of On-Demand TACE Combined With Atezolizumab Plus Bevacizumab (Atezo/Bev) or On-Demand TACE Alone in Patients With Untreated Heaptocellular Carcionma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 342
- 试验地点
- 58
- 主要终点
- TACE Progression-Free Survival (TACE PFS) as Determined by Investigator
研究概览
简要总结
This study will evaluate the efficacy and safety of atezolizumab plus bevacizumab combined with on-demand TACE compared to on-demand TACE alone in participants with hepatocellular carcinoma who are at high risk of poorer outcome following TACE treatment.
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
- •Confirmed diagnosis of HCC by histology/ cytology or clinical criteria
- •Eligible for TACE treatment
- •No prior systemic therapy for HCC, especially immunotherapy
- •No prior locoregional therapy to the target lesion(s)
- •At least one measurable untreated lesion
- •ECOG Performance Status of 0-1
- •Child-Pugh class A
排除标准
- •Evidence of Vp3/4 and hepatic vein tumor thrombus (HVTT)
- •Evidence of extrahepatic spread (EHS)
- •Being a candidate for curative treatments
- •Any condition representing a contraindication to TACE as determined by the investigators
- •Active or history of autoimmune disease or immune deficiency
- •Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding
- •A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
- •Evidence of bleeding diathesis or significant coagulopathy
研究组 & 干预措施
Arm A: atezolizumab + bevacizumab + TACE
Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
干预措施: Becavizumab (Drug)
Arm A: atezolizumab + bevacizumab + TACE
Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
干预措施: Transarterial chemoembolization (TACE) (Device)
Arm B: TACE alone
Participants will receive on-demand transarterial chemoembolization.
干预措施: Transarterial chemoembolization (TACE) (Device)
Arm A: atezolizumab + bevacizumab + TACE
Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
TACE Progression-Free Survival (TACE PFS) as Determined by Investigator
时间窗: Randomization to untreatable progression or TACE failure/refractoriness or death (up to approximately 46 months)
TACE PFS is defined as the time from randomization to untreatable progression or TACE failure/refractoriness or any cause of death, whichever occurs first, as determined by the investigator (INV).
Overall Survival (OS)
时间窗: Randomization to death from any cause (up to approximately 94 months)
Overall survival (OS) after enrollment is defined as the time from randomization to death from any cause.
次要结局
- Time to Untreatable (unTACEable) Progression (TTUP) as Determined by Investigator(Randomization to untreatable (unTACEable) progression (up to approximately 46 months))
- Time to Progression (TTP) as Determined by Investigator(Randomization to unTACEable progression or TACE failure/refractoriness (up to approximately 46 months))
- Time to Extrahepatic Spread (EHS) as Determined by Investigator(Randomization to first evidence of EHS (up to approximately 46 months))
- Objective Response Rate (ORR), as Determined by Investigator(Randomization up to approximately 46 months)
- Duration of Responses (DOR) as Determined by Investigator(First occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first)(up to approximately 46 months))
- Progression Free Survival (PFS)(Randomization to first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 94 monthsJ))
- Time to Deterioration (TTD)(Randomization to first deterioration (up to approximately 94 months))
- Percentage of Participants With Adverse Events(Baseline up to approximately 94 months)