Abstract
OBJECTIVE: Transarterial chemoembolization (TACE) is standard of care for patients with unresectable hepatocellular carcinoma (uHCC) that is amenable to embolization; however, its long-term prognosis is limited. Recently, TACE with systemic therapies showed meaningful improvement in clinical outcomes. This study aims to evaluate the real-world efficacy and safety of transarterial chemoembolization (TACE) combined with sintilimab and a bevacizumab biosimilar in the treatment of unresectable hepatocellular carcinoma (uHCC), which has been incorporated into the first-line treatment regimen in China. METHODS: A retrospective analysis was conducted on 60 patients with uHCC who received TACE combined with sintilimab (200mg IV, q3w) and a bevacizumab biosimilar (15mg/kg IV, q3w) at Ganzhou People's Hospital from August 2019 to June 2024, with follow-up until June 30, 2025. Overall survival (OS), progression-free survival (PFS), post-treatment tumor response, and treatment-related adverse events (tr-AEs) were recorded and analyzed. Use Kaplan-Meier for survival and Cox model for risk factors. RESULTS: A total of 60 patients were enrolled in this study. The median OS was 24.0 months, and the median PFS was 13.0 months. According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, the best overall response rate (ORR) was 35.0%, and the disease control rate (DCR) was 91.7%. Based on the modified RECIST (mRECIST) criteria, the best ORR and DCR were 83.3% and 91.7%, respectively. Multivariate analysis identified macrovascular invasion as an independent risk factor for both OS and PFS (P < 0.05). All tr-AEs were manageable, and no treatment-related deaths occurred. CONCLUSION: TACE plus sintilimab-bevacizumab biosimilar has favorable efficacy and manageable safety in patients with uHCC, supporting its use as a treatment option in HCC.