Abstract: Objective To observe the efficacy and safety of sintilimab combined with sorafenib in the treatment of advanced primary liver carcinoma (PLC). Methods Using the prospective study method, 198 patients with advanced PLC admitted to Wuxi 904 Hospital from July 2019 to January 2022 were divided into the experimental group and control group. The anti-tumor efficacy, tumor markers, immune function, liver function, drug safety and survival within 1 year of continuous treatment were compared between the two groups after 3 cycles of continuous treatment. Results The anti-tumor efficacy [objective remission rate (41.41% vs. 26.26) and clinical control rate (76.77% vs. 60.61%)] of the test group was better than that of the control group (P<0.05), and there was no difference in safety (31.31% vs. 28.28%) and survival (P>0.05). After treatment, carcinoembryonic antigen [(15.24±3.01) ng/mL], alpha-fetoprotein [(119.84±20.19) ng/mL], glycan antigen 199 [(98.32±16.38) U/mL], Th1/Th2 [(4.98±0.64)], and Th17/Treg [(1.03±0.16)], and CD4⁺/CD8⁺ [(1.41±0.21)] levels in the study group were better than those in the control group [(19.87±3.25) ng/mL, (152.31±28.69) ng/mL, (128.65±20.34) U/mL, (5.39±0.72), (1.21±0.18), (1.23±0.19)] (P< 0.05). Conclusion The combination of sintilimab and sorafenib can effectively reduce the level of tumor markers in patients with advanced PLC, improve the immune function of patients, and have a high safety profile.

Key words: Sindilimab, Sorafenib, Advanced primary liver cancer, Effect, Security