Abstract: Objective To assess the effectiveness of sintilimab in combination with drug-loaded microspheres transarterial chemoembolization (DEB-TACE) for the treatment of advanced primary liver cancer (PLC). Methods A total of 97 patients with advanced PLC treated at Tai′an Tumor Hospital in Shandong Province from March 2021 to April 2024 were included in the study. They were divided into two groups based on their treatment methods. The control group consisted of 47 patients who underwent DEB-TACE treatment, the observation group had fifty patients and they were treated with sintilimab. The treatment effects, alterations in liver function index, levels of tumor markers and immune function,as well as the incidence of adverse reactions were compared between the two groups. Results The treatment effects of the observation group were better than those of the control group [objective response rate: 58.00% (29/50) vs. 36.17% (17/47);disease control rate:66.00% (33/50) vs. 44.68% (21/47)], with improved liver function index [total bilirubin(TBil): (12.30±1.24) μmol/L vs. (14.02±1.29) μmol/L;aspartate aminotransferase (AST): (31.02±2.45) U/L vs. (37.18±2.69) U/L; alanine aminotransferase (ALT):(24.63±3.52) U/L vs. (29.85±3.74) U/L], immue indexes of tumor markers [carcinoembryonic antigen (CEA): (65.63±3.41)% vs. (61.63±3.02)%; alpha-fetoproteinvariant-L3 (AFP-L3): (43.36±4.43)% vs. (40.39±4.87)%; alpha-fetoprotein (AFP): (25.63±2.74)% vs. (27.63±2.98)%] and indexes of immune function [CD3⁺: (65.63±3.41)% vs. (61.63±3.02)%;CD4⁺: (43.36±4.43)% vs. (40.39±4.87)%; CD8⁺: (25.63±2.74)% vs.(27.63±2.98)%] (All P<0.05). The incidence of adverse reactions of the observation group was lower than that of the control group [6.38% (6/47) vs. 6.00% (6/50)] (P>0.05). After a 6-month follow-up, the mortality rates between the two groups were compared (Log-rank χ²=0.353, P=0.553). Conclusion The combination of sintilimab and DEB-TACE demonstrates significant therapeutic effects in improving the levels of tumor markers, indexes of liver function and immune function, without increasing adverse reactions, and is associated with a lower mortality rate.

Key words: Sintilimab, Transarterial microsphere chemoembolization, Intermediate and advanced primary liver cancer