Abstract: Objective The aim of this study was to investigate the clinical efficacy of transcatheter arterial chemoembolization (TACE) in combination with lenvatinib and sintilimab in treating patients with exceeding up-to-seven criteria primary liver cance (PLC). Methods 96 patients with PLC beyond the up-to-seven criteria were admitted to our hospital between June 2021 and September 2024, 48 patients in the observation group received TACE with combination of lenvatinib and sintilimab, and another 48 patients in the control group received TACE in combination with lenvatinib alone. Tumor response was evaluated based on mRECIST criteria. Univariate and multivariate Cox regression analysis were performed to identify factors influencing progression-free survival (PFS) in PLC patients. Results The objective response rate (ORR) and disease control rate (DCR) in the observation group were 43.8% and 89.6%,both significantly higher than 22.9% and 72.9% in the control group (P<0.05); the progression-free survival (mPFS) and overall survival (OS) in the observation group were 15.3 months and 23.0 months , both significantly higher than 11.2 months and 15.0 months in control group (P<0.05); the multivariate Cox regression analysis identified that the treatment regimen, portal vein tumor thrombus (PVTT) and serum AFP >400μg/L were the independent prognostic factors affecting PFS(P<0.05). Conclusion The combination of lenvatinib and sintilimab after TACE could effectively reduce tumor burdens and prolong survival in patients with PLC exceeding the up-to-seven criteria.

Key words: Hepatoma, Transcatheter arterial chemoembolization, Sintilimab, Lenvatinib, Therapy