Comparing of Efficacy and Safety Between Sintilimab Plus IBI305 and PD-1 Inhibitor Plus TKIs in Combination of TACE for uHCC.

BACKGROUND

Systemic therapy combined with transcatheter arterial chemoembolization (TACE) is the main treatment strategy for patients with unresectable hepatocellular carcinoma (uHCC). Nevertheless, there are currently few direct comparative studies between different combined treatment regimens. Therefore, this study aims to compare the efficacy and safety of sintilimab and bevacizumab biosimilar (IBI305) versus PD-1 inhibitor and tyrosine kinase inhibitor (TKI) combined with TACE in the treatment of uHCC.

METHODS

This retrospective study included 225 patients with uHCC who received either TACE combined with sintilimab and IBI305 (TSB group, n = 84) or other PD-1 inhibitors and TKIs (TTP group, n = 141). This study evaluated overall survival (OS) as the primary outcome, with secondary endpoints encompassing progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR)and treatment-related adverse events (TRAEs). To mitigate potential confounding biases across the two cohorts, propensity score matching (PSM) was employed.

RESULTS

Following PSM, 136 uHCC patients were included, with 68 in both the TSB and TTP groups. There was no statistical difference in OS (p = 0.18) or PFS (p = 0.34) between the TSB group and the TTP group. According to both RECIST1.1 and mRECIST criteria, there were no notable changes in ORR or DCR. Both groups demonstrated manageable toxicity profiles. Subgroup analysis suggested that whereas patients with large tumours (HR, 0.33; p = 0.024), solitary lesions (HR, 0.16; p < 0.001) or portal vein tumour thrombosis (HR, 0.43; p = 0.033) derived greater survival benefit from the TSB regimen, those with multifocal tumours (HR, 1.86; p = 0.033) benefited more from the TTP regimen.

CONCLUSIONS

The TSB and TTP regimens offer comparable efficacy and safety in uHCC, yet the TSB regimen appears to offer greater benefit in specific patient subgroups.