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临床试验/NCT06199297
NCT06199297已完成不适用

Atezolizumab Plus Bevacizumab Versus Sintilimab Plus Bevacizumab With Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: A Multicenter Real-World Study

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2021年3月2日最近更新:
适应症
干预措施
相关药物

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

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

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Binkui Li

Professor

Sun Yat-sen University

研究点 (1)

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