Atezolizumab Plus Bevacizumab Versus Sintilimab Plus Bevacizumab With Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: A Multicenter Real-World Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- progression free survival,PFS
研究概览
简要总结
Systemic therapy is the primary option for managing advanced hepatocellular carcinoma (HCC). The combination of atezolizumab and bevacizumab (A+B) has emerged as the first-choice treatment for advanced HCC(IM brave 150). The ORIENT-32 study, also reported an ORR of 24% for sintilimab plus a bevacizumab biosimilar (S+B) versus 8% for sorafenib, with significantly longer OS and PFS. Based on those therapeutic advantages over sorafenib, both the A+B and S+B regimens were approved as first-line treatment options for advanced HCC in China. These two trials had very similar designs but included different target populations. Our previous studies have demonstrated that a novel treatment approach combining transarterial chemoembolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) has high efficacy in patients with potentially resectable HCC or portal vein tumor thrombus. However, it remains unknown whether combining immune checkpoint inhibitors and macromolecular VEGF-targeted therapy with transvascular local interventions could improve patient prognosis in uHCC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •(a) a confirmed diagnosis of uHCC;
- •(b) at least one target lesion evaluable by both RECIST 1.1 and mRECIST criteria;
- •(c) Child-Pugh Grade A or B.
排除标准
- •(a) previous exposure to other anti-cancer treatments;
- •(b) diagnosis of any other primary malignancy;
- •(c) significant esophageal varices or observable red wale marks;
- •(d) a history of severe cardiac, pulmonary, or renal comorbidities;
- •(e) incomplete follow-up records.
研究组 & 干预措施
ABTH
Atezolizumab plus bevacizumab combined with TACE-HAIC
干预措施: Atezolizumab combined with Bevacizumab (Drug)
ABTH
Atezolizumab plus bevacizumab combined with TACE-HAIC
干预措施: Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy (Procedure)
SBTH
Sintilimab plus bevacizumab combined with TACE-HAIC
干预措施: Sintilimab combined with Bevacizumab (Drug)
SBTH
Sintilimab plus bevacizumab combined with TACE-HAIC
干预措施: Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy (Procedure)
结局指标
主要结局
progression free survival,PFS
时间窗: 24 months
Assessed using the mRECIST criteria, defined as patient survival without tumor progression from the start of randomization to the end of year 2
objective response rate,ORR
时间窗: 24 months
Evaluated according to the criteria for evaluating efficacy in solid tumors (mRECIST and RECIST 1.1)
次要结局
- treatment-related adverse events, TRAEs(24 months)
- overall survival, OS(24 months)
研究者
Binkui Li
Professor
Sun Yat-sen University
