Abstract
INTRODUCTION: This study evaluated the efficacy and safety of the triple combination of transcatheter arterial chemoembolization (TACE), lenvatinib, and tislelizumab in patients with advanced unresectable hepatocellular carcinoma. METHODS: Patients with confirmed HCC in Barcelona Clinic Liver Cancer stage C were included. Patients were initially treated with TACE, followed by intravenous tislelizumab (200 mg, IV) every 21 days and lenvatinib (8 or 12 mg/day) once daily. The primary endpoint was objective response rate based on the modified Response Evaluation Criteria in Solid Tumors (mRECIST). The secondary endpoints included disease control rate based on mRECIST, objective response rate and disease control rate based on the Response Evaluation Criteria in Solid Tumors (version 1.1), overall survival (OS), progression-free survival (PFS), time to progression (TTP), duration of response (DOR), and safety. An exploratory endpoint was systemic immune-inflammation index (SII). RESULTS: Thirty-one patients with advanced unresectable HCC were enrolled. The objective response rate was 74.2% and disease control rate was 87.1% based on mRECIST. The median OS was 12.6 months and median PFS was 6.5 months. The median TTP was 8.2 months, and median DOR was 7.3 months. Treatment-related adverse events occurred in 64.5% of patients, and most events were grade1-2. The rate of grade ≥3 events was 19.4%. Overall survival and progression-free survival after triple therapy were better in patients with lower SII at baseline. CONCLUSION: The combination of TACE, lenvatinib, and tislelizumab can be effective against advanced unresectable HCC, leading to a relatively high objective response rate and tolerable safety profile. SII may be useful for predicting response to this triple therapy. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05131698, registered 4 November 2021.