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

NCT ID: NCT06199297

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 188 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2023-07-25

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

ABTH

Atezolizumab plus bevacizumab combined with TACE-HAIC

Atezolizumab combined with Bevacizumab

Intervention Type: DRUG

Atezolizumab 1200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions

Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy

Intervention Type: PROCEDURE

The chemoembolization process employed 30 mg/m2 of epirubicin and 2-10 mL of lipiodol. This was followed by FOLFOX-based HAIC, including 85 mg/m2 of oxaliplatin, 400 mg/m2 of leucovorin, and an initial bolus of 400 mg/m2 of 5-FU for 2 h, which was then followed by a sustained infusion of 1200 mg/m2 5-FU for 23 h.

SBTH

Sintilimab plus bevacizumab combined with TACE-HAIC

Sintilimab combined with Bevacizumab

Intervention Type: DRUG

Sintilimab 200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions

Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy

Intervention Type: PROCEDURE

The chemoembolization process employed 30 mg/m2 of epirubicin and 2-10 mL of lipiodol. This was followed by FOLFOX-based HAIC, including 85 mg/m2 of oxaliplatin, 400 mg/m2 of leucovorin, and an initial bolus of 400 mg/m2 of 5-FU for 2 h, which was then followed by a sustained infusion of 1200 mg/m2 5-FU for 23 h.

Interventions

Atezolizumab combined with Bevacizumab

Atezolizumab 1200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions

Intervention Type: DRUG

Sintilimab combined with Bevacizumab

Sintilimab 200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions

Intervention Type: DRUG

Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy

The chemoembolization process employed 30 mg/m2 of epirubicin and 2-10 mL of lipiodol. This was followed by FOLFOX-based HAIC, including 85 mg/m2 of oxaliplatin, 400 mg/m2 of leucovorin, and an initial bolus of 400 mg/m2 of 5-FU for 2 h, which was then followed by a sustained infusion of 1200 mg/m2 5-FU for 23 h.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Binkui Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wei He

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

B2023-690-01

Identifier Type: -

Identifier Source: org_study_id