Efficacy and safety of sintilimab plus a bevacizumab biosimilar combined with transarterial chemoembolization for advanced hepatocellular carcinoma.

Sintilimab with a bevacizumab biosimilar has been proved to have promising antitumor activity in patients with unresectable hepatocellular carcinoma (HCC). Patients with advanced HCC also showed promising survival outcomes and substantial response rates with transarterial chemoembolization (TACE). The objective of this study was to investigate the initial clinical effectiveness and safety of combining sintilimab and a bevacizumab biosimilar (Sin + Bev) with TACE in treatment-naive patients with advanced HCC. This retrospective study included patients with advanced HCC who were treated with first-line Sin + Bev and TACE between June 2020 and January 2024. According to modified response evaluation criteria in solid tumors (mRECIST) criteria, we analyzed progression-free survival (PFS), overall survival (OS), and tumor response. Adverse events (AEs) were gathered as well. Cox proportional hazard regression models were used to determine prognostic factors affecting OS and PFS. Twenty-six patients were included. According to mRECIST, the objective response rate was 53.8% (14/26) and the disease control rate was 80.8% (21/26), including 1 patient with complete response (CR). The median follow-up was 28.9 months (IQR, 25.8-32.0). The median PFS and OS were 12.0 months (95% CI: 10.5-13.5) and 23.8 months (95% CI: 19.4-28.2), respectively. Child-Pugh and up-to-seven were both independently correlated with OS. The most frequent AEs included Pyrexia (7 cases) and Decreased neutrophil count (7 cases). Grade 4 AEs occurred in one patient as increased aspartate aminotransferase and alanine aminotransferase, but no 5 AEs were observed. The combination of sintilimab plus a bevacizumab biosimilar with TACE showed a significant therapeutic effect in patients with advanced HCC. Additionally, the AEs associated with this treatment were manageable.