Efficacy and Safety of TACE-HAIC Combined with Molecular Targeted Therapy and Immune Checkpoint Inhibitors for Unresectable Hepatocellular Carcinoma.

PURPOSE: To evaluate the efficacy and safety of a quadruple regimen of transarterial chemoembolization (TACE)-hepatic arterial infusion chemotherapy (HAIC) plus molecular targeted therapy (MTT) and immune checkpoint inhibitors (ICIs) for unresectable hepatocellular carcinoma (uHCC).

PATIENTS AND

METHODS

274 uHCC patients were divided into two groups based on two treatment methods:TACE-HAIC combined with MTT and ICIs (THTI) and TACE combined with MTT and ICIs (TTI). The primary endpoints were progression-free survival (PFS) and overall survival (OS). The secondary endpoints included the objective response rate (ORR), disease control rate (DCR), and treatment-related adverse events (TRAEs).

RESULTS

After Propensity score matching (PSM), the THTI group significantly prolonged median PFS (14.0 vs 10.6 months, P< 0.001) and median OS (30.8 vs 24.8 months, P = 0.001) compared with the TTI group. Compared with the TTI group, the THTI group demonstrated significantly superior ORR (64.5% vs 44.9%, P=0.004) and DCR (94.4% vs 84.1%, P=0.015). In addition, responses to THTI (THTI-R) had superior median PFS (17.1 vs 13.8 months, P = 0.007) and median OS (38.1 vs 27.5 months, P = 0.002) versus responses to TTI (TTI-R). All adverse events were manageable in two groups.

CONCLUSION

For patients with uHCC, the THTI quadruple therapy demonstrated a superior clinical benefit over current TTI triple therapy, including significant prolongation of both PFS and OS, as well as improvements in ORR and DCR, with a manageable safety profile.