Efficacy and safety of transarterial chemoembolization (TACE) with tislelizumab and tyrosine kinase inhibitors versus TACE for intermediate and advanced HCC

Transarterial chemoembolization (TACE) combined with targeted therapy and immunotherapy is a promising approach for intermediate and advanced hepatocellular carcinoma (HCC). This study aimed to compare the efficacy and safety of TACE plus tislelizumab and tyrosine kinase inhibitors (TKIs) versus TACE alone. This retrospective study analyzed patients with intermediate and advanced HCC treated from February 2018 to September 2023. Patients were divided into two groups: the combination therapy group (TACE plus tislelizumab and TKIs) and the monotherapy group (TACE alone). The primary endpoint was progression-free survival PFS), and secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. Cox regression, sensitivity analysis, Kaplan–Meier survival curves, and restricted mean survival time (RMST) analysis were performed to assess the robustness of the PFS benefit. A total of 62 patients were included (30 in the combination group, 32 in the monotherapy group), with balanced baseline characteristics. After a median follow-up of 33.3 months, median PFS was 11.7 months in the combination group and 3.8 months in the monotherapy group (hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.24–0.77; P = 0.0034). This benefit persisted after multivariable adjustment (adjusted HR, 0.28; 95% CI 0.14–0.57; P < 0.001) and was confirmed by sensitivity and RMST analyses at 12, 24, 36, and 48 months (all P < 0.01). The combination group also showed favorable outcomes in secondary endpoints including ORR, DCR, and OS rates. Four patients (13.3%) in the combination group underwent downstaging to curative treatment, with PFS ranging from 14.8 to 49.2 months. Grade ≥ 3 adverse events occurred in 10.0% of the combination group and in none of the monotherapy group, with no treatment-related deaths. TACE combined with tislelizumab and TKIs significantly improved PFS compared with TACE alone, with a manageable safety profile, in patients with intermediate and advanced HCC. This regimen may offer a potential conversion option for selected patients in this population.