Efficacy and Safety Analysis of Transarterial Chemoembolization Combined with Sintilimab Plus Bevacizumab Biosimilar in the Treatment of Unresectable Hepatocellular Carcinoma.

Background: Transarterial chemoembolization (TACE) remains a cornerstone for unresectable hepatocellular carcinoma (uHCC) but is limited by tumor progression. Combining TACE with systemic therapies may enhance efficacy. Notably, sintilimab combined with bevacizumab biosimilar has shown synergistic effects in tumor control and has been incorporated into the first-line treatment regimen in China. This study evaluates the therapeutic efficacy and safety of TACE combined with sintilimab and bevacizumab biosimilar in patients with uHCC.

Methods: This retrospective cohort study analyzed 76 uHCC patients who received TACE plus sintilimab-bevacizumab biosimilar at the First Affiliated Hospital of Guilin Medical University between September 2020 and March 2024, with follow-up continuing until March 31, 2025. The primary outcomes, overall survival (OS) and progression-free survival (PFS), were evaluated through Kaplan-Meier survival analysis. Independent risk factors for OS and PFS were evaluated using both univariate and multivariate analyses. Secondary outcomes comprised objective response rate (ORR), disease control rate (DCR), and treatment-related adverse events (tr-AEs).

Results: The study cohort comprised 76 patients meeting predefined eligibility criteria, achieving median OS of 23.2 months and median PFS of 14.5 months. Tumor response was assessed per mRECIST criteria, demonstrating an ORR of 59.2% and DCR of 81.6%. Multivariable analysis confirmed the modified albumin-bilirubin (mALBI) grade 3, alpha-fetoprotein (AFP) level, and macrovascular invasion as independent risk factors for OS and PFS (all P<0.05). All tr-AEs were manageable, with no fatal events reported.

Conclusion: TACE combined with sintilimab and bevacizumab biosimilar demonstrated favorable efficacy and manageable safety in patients with uHCC.