Efficacy and Safety of Tislelizumab as an Immune Checkpoint Inhibitor for the Treatment of Advanced Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis.

Hepatocellular carcinoma (HCC) remains a leading global cause of cancer-related mortality, necessitating effective systemic therapies. Tislelizumab, a novel anti-PD-1 monoclonal antibody, has shown promise in recent trials. However, a pooled assessment of its clinical efficacy and safety in HCC treatment has been lacking. To systematically evaluate and quantify the efficacy and safety of tislelizumab in HCC, focusing on key outcomes including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and treatment-related adverse events (TRAEs), a systematic search of PubMed, Scopus, Cochrane Library, ScienceDirect, the American Society of Clinical Oncology (ASCO), and the European Society of Medical Oncology (ESMO) databases was conducted for clinical trials from January 2010 to October 2024. Seven studies involving 1,178 patients were included in the analysis. Statistical analyses were performed using the Comprehensive Meta-Analysis software (version 3.7). Fixed-effect and random-effects models were used based on heterogeneity (I² statistic), and publication bias was assessed using Egger's and Begg's tests, alongside Duval and Tweedie's trim-and-fill method. The pooled ORR was estimated at 22.3% (logit = -1.242; SE = 0.0897), but after correcting for publication bias (Egger's p = 0.027), the adjusted ORR decreased to 17.2%. The pooled OS was 13.66 months (95% CI: 11.97-15.35) with no heterogeneity (I² = 0%), affirming the robustness of the survival benefit. PFS was 4.58 months under a fixed-effect model but increased to 5.86 months with the random-effects model due to high heterogeneity (I² = 93.15%). The incidence of Grade ≥ 3 TRAEs was 28.9% (logit = -0.448), indicating a manageable safety profile, with no significant publication bias (Egger's p = 0.251). Tislelizumab demonstrates favorable clinical activity in HCC, offering meaningful improvements in survival and disease control with acceptable toxicity. While ORR results were influenced by potential publication bias, survival and safety outcomes were consistent and reliable. These findings support tislelizumab as a viable immunotherapeutic option for advanced HCC, warranting further exploration in larger, randomized trials and combination therapy regimens to optimize patient outcomes.