Objective  To Analyze tislelizumab (TIS) combined with sorafenib (SRF) as the first-line treatment regimen for unresectable hepatocellular carcinoma (HCC).

Methods  Clinical data of patients with unresectable HCC treated in Jinhua Hospital and Shulan (Hangzhou) Hospital affiliated to Zhejiang University School of Medicine from January 2020 to January 2023 were retrospectively analyzed. They were divided into a combined group (TIS combined with SRF) and a control group (SRF) according to the diagnosis and treatment protocol. The main observational indexes of the study were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). In addition, attention was paid to the occurrence of adverse reactions during the treatment to assess safety.

Results  A total of 61 patients were included in the study, with 31 in the combined group and 30 in the control group. The difference in ORR between the two groups was not statistically significant (P>0.05), while DCR was significantly higher in the combined group than in the control group (P<0.05). Survival analysis showed that the median PFS and median OS of the combined group were significantly higher than those of the control group (P<0.05). In terms of safety, there was no statistically significant difference in the incidence of hand-foot syndrome, transaminase elevation, loss of appetite, proteinuria, rash, diarrhea, thrombocytopenia, and malaise between the two groups (P>0.05); whereas 8 cases of hypothyroidism (25.81%) and 4 cases of capillary hyperplasia (12.90%) occurred in the combined group, and no hypothyroidism or capillary hyperplasia occurred in the control group. In addition, no patients died or discontinued treatment due to adverse effects.

Conclusion  Compared to single drug SRF, the combination of TIS and SRF first-line treatment for unresectable HCC can improve DCR, prolong median PFS and OS, and the safety is controllable.

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