Atezolizumab Plus Bevacizumab Versus Sintilimab Plus Bevacizumab With TACE and HAIC in Unresectable Hepatocellular Carcinoma

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Atezolizumab combined with Bevacizumab; Drug: Sintilimab combined with Bevacizumab; Procedure: Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy

• Registration Number: NCT06199297
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-02
• Primary Completion: 2023-07-25
• Study Completion: 2023-07-25
• Study First Submitted: 2023-12-28
• Study First Submitted QC: 2023-12-28
• Status Verified: 2024-01
• Study First Posted: 2024-01-10
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

• (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.

Exclusion Criteria

• (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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ABTH	Atezolizumab combined with Bevacizumab	Atezolizumab plus bevacizumab combined with TACE-HAIC
SBTH	Sintilimab combined with Bevacizumab	Sintilimab plus bevacizumab combined with TACE-HAIC
SBTH	Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy	Sintilimab plus bevacizumab combined with TACE-HAIC
ABTH	Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy	Atezolizumab plus bevacizumab combined with TACE-HAIC

Primary Outcome Measures

Name	Time	Method
progression free survival，PFS	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	24 months	Evaluated according to the criteria for evaluating efficacy in solid tumors (mRECIST and RECIST 1.1)

Secondary Outcome Measures

Name	Time	Method
treatment-related adverse events, TRAEs	24 months	incidence rates of treatment-related adverse events during the study
overall survival, OS	24 months	Defined as the time from the start of randomization to death from any cause

Trial Locations

Locations (1)

Wei He; 🇨🇳 Guangzhou, Guangdong, China