Abstract: Objective The aim of this study was to investigate clinical efficacy of lenvatinib mesylate in combination with toripalimab in the treatment of patients with advanced primary liver cancer(aPLC). Methods 102 patients with aPLC were encountered in our hospital between August 2021 and August 2024, and were randomly divided into control and observation group, with 51 cases in each group. Patients in the control group were treated with lenvatinib mesylate alone, while those in the observation group received lenvatinib mesylate and toripalimab combination therapy. Anti-tumor regimen lasted for three cycles (21 days one cycle) in the two groups. Serum tumor-specific growth factor (TSGF), alpha-fetoprotein (AFP) and abnormal prothrombin-Ⅱ (PIVKA-Ⅱ) levels were detected by chemiluminescence immunoassay. Peripheral blood T lymphocyte subsets were determined by flow cytometry. Results Objective remission rate and disease control rate in the observation group were 58.8% and 82.4%, both much higher than 37.3% and 62.8%(P<0.05) in the control group; serum TSGF, AFP and PIVKA-Ⅱ levels were (60.3±6.5)U/mL, (142.9±19.1)μg/L and (871.8±91.4)ng/mL, all significantly lower than [(70.2±7.3)U/mL, (227.1±31.8)μg/L and (1029.7±95.3)ng/mL, respectively, P<0.05] in the control; percentages of peripheral blood CD3⁺ and CD4⁺ cells, and CD4⁺/CD8⁺ cell ratio were (42.3±5.4)%, (33.4±3.9)% and (1.4±0.4), all much higher than [(39.5±4.8)%, (29.3±3.5)% and (1.1±0.3), respectively, P<0.05], while percentage of CD8⁺ cells was (23.2±3.1)%, much lower than [(26.3±3.7)%, P<0.05] in the control group. Conclusion Lenvatinib mesylate in combination with toripalimab therapy exhibits a short-term promising efficacy in the treatment of patients with aPLC, which might be owning to improvement of body immune functions and inhibition of tumor growth.

Key words: Hepatoma, Advanced, Lenvatinib mesylate, Toripalimab, Lymphocyte subsets, Therapy