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

Sun Yat-sen University

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy; Drug: Atezolizumab combined with Bevacizumab; Drug: Sintilimab combined with Bevacizumab

Study type: Observational

Funder types: Other

Identifiers

NCT06199297

B2023-690-01

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

188 participants in 2 patient groups

ABTH

Description:

Atezolizumab plus bevacizumab combined with TACE-HAIC

Treatment:

Drug: Atezolizumab combined with Bevacizumab

Procedure: Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy

SBTH

Description:

Sintilimab plus bevacizumab combined with TACE-HAIC

Treatment:

Procedure: Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy

Drug: Sintilimab combined with Bevacizumab