Abstract
BACKGROUND: Trials on tyrosine kinase inhibitors combined with sintilimab and transarterial chemoembolization (TKIs-Sin-TACE) for the treatment of unresectable hepatocellular carcinoma (HCC) are ongoing and show promising results. However, the number of participants recruited so far has been relatively limited. This pooled analysis aims to evaluate the efficacy and safety of TKIs-Sin-TACE in patients with Barcelona Clinic Liver Cancer (BCLC) stage B/C HCC. METHODS: To obtain potentially eligible studies, databases such as PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov were searched up to October 1, 2024. The Methodological Index for Non-Randomized Studies (MINORS) was used to evaluate literature quality and the levels of bias. A random-effects model was utilized to calculate the pooled rate and confidence interval (CI). RESULTS: This study included six studies involving a total of 336 patients with HCC at BCLC stage B/C. Regarding efficacy, the pooled objective response rate, disease control rate, integrated rates for 10-month progression-free survival, 10-month overall survival (OS), 20-month OS were 39% (95% CI: 26-55%),74% (95% CI: 60-84%),41% (95% CI: 30-54%), and 73% (95% CI: 54-86%), 30% (95% CI: 16-49%), respectively. Regarding safety, the aggregated incidence of treatment-related adverse events ≥ grade 3 was 23% (95% CI: 12-42%). CONCLUSIONS: TKIs-Sin-TACE exhibits an efficacious and safe profile for Chinese patients with BCLC stage B/C HCC. Large-scale, global multicenter randomized-controlled trials are needed to further validate these findings.