Abstract
OBJECTIVE: To evaluate the clinical efficacy, immune function effects and safety of lenvatinib combined with immune checkpoint inhibitors (sintilimab) in treating advanced primary liver cancer. METHODOLOGY: A retrospective cohort study was conducted on 80 patients with advanced liver cancer in Shijiazhuang People's Hospital from January 2023 to June 2024, who were divided into an observation group (lenvatinib + sintilimab, n=40) and a control group (lenvatinib monotherapy, n=40). Specifically, the overall response rate (ORR), immune function indicators (CD3+, CD4+, CD4+/CD8+, IgM/IgG/IgA), quality of life (SGRQ scores) and adverse reactions were compared between the two groups. RESULTS: The ORR in the observation group (72.5%) was significantly higher than that in the control group (50.0%), with statistically significant differences (P=0.039). After treatment, the improvement in levels of CD3+, CD4+, CD4+/CD8+ and immunoglobulins (IgM, IgG, IgA) in the observation group significantly outperformed those in the control group, with statistically significant differences (all P<0.05). Additionally, the observation group reported more substantially improved SGRQ scores than the control group and differences were statistically significant (P<0.001). In terms of safety, no statistical differences were observed regarding the incidence of adverse reactions in both groups (P=0.369). CONCLUSION: Lenvatinib combined with immune checkpoint inhibitors can significantly improve the objective response rate in patients with advanced liver cancer, enhance their immune function and improve their quality of life, demonstrating satisfactory safety.