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Sorafenib Combined with Tislelizumab and Transarterial Chemoembolization for Advanced-Stage Hepatocellular Carcinoma: A Phase II Study

Year: 2025

Type: article

Abstract: Purpose: To evaluate the efficacy and safety of sorafenib combined with tislelizumab (a programmed death-1 inhibitor) and transarterial chemoembolization (TACE) in patients with advanced-stage hepatocellular carcinoma (HCC). Patients and Methods: This was a single-center, single-arm phase II trial. Patients with HCC at Barcelona Clinic Liver Cancer stage C were recruited. Treatment with sorafenib (400 mg orally twice daily) and tislelizumab (200 mg intravenously every 3 weeks) was initiated 3-7 days after the first TACE procedure. Repeated TACE was performed on-demand. The primary endpoint of this study was overall survival (OS). Results: Thirty patients were enrolled. The median OS for the patients was 18.3 (95% CI = 14.6-22.0) months, with 12-, 18-, and 24-month OS rates of 90.0%, 54.0%, and 28.3%, respectively. The objective response rate was 53.3% per modified Response Evaluation Criteria in Solid Tumors (mRECIST) and 20.0% per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The disease control rate was 86.7% per mRECIST/RECIST 1.1. The median progression-free survival was 6.8 (95% CI = 4.5-9.0) months per mRECIST/RECIST 1.1. The median duration of response was 7.1 (95% CI = 6.1-8.1) months per mRECIST (n = 16) and 4.4 (95% CI = 0.9-7.9) months per RECIST 1.1 (n = 6). Treatment-related adverse events (TRAEs) occurred in 28 patients (93.3%), and grade 3 TRAEs were observed in 11 patients (36.7%). There were no grade 4/5 TRAEs. Conclusion: Sorafenib combined with tislelizumab and TACE showed promising antitumor activities with a manageable safety profile in patients with advanced-stage HCC. These preliminary findings warrant further evaluation in Phase III randomized trials.

Source: ImmunoTargets and Therapy