Abstract
To investigate the effectiveness of TACE in combination with anlotinib and sintilimab in the treatment of unresectable hepatocellular carcinoma. A total of 210 patients with primary unresectable hepatocellular carcinoma (PAC) in our hospital from January 2020 to December 2023 were selected as the study subjects, and they were divided into two groups of 105 cases each by the envelope method using sequentially numbered, opaque sealed envelopes containing computer-generated random allocations. The control group was treated with TACE combined with anlotinib, and the study group was treated with sintilimab on the basis of the control group, and all patients were followed up for 18 months or until death or loss to follow-up, and the differences in treatment efficacy, safety, tumor markers, tumor growth factors and patient recovery between the two groups were compared. The DCR and ORR of the study group were 81.90% and 49.52%, which were significantly higher than those of the control group (61.90%) and 35.24%, and the difference was statistically significant(P = 0.042 and P = 0.029, respectively). The PFS (12.54 ± 0.39 months) and OS (17.52 ± 0.98 months) in the study group were significantly higher than those in the control group (8.65 ± 0.97 months) and OS (12.94 ± 1.55 months), and the difference was statistically significant (P = 0.001), and the survival rates of patients in the study group were 75.24% and 53.33% after 12 months and 18 months, which were significantly higher than those in the control group (70.48% and 31.43%), and the difference was statistically significant(P = 0.013 and P = 0.011, respectively). The incidence of myelosuppression and liver damage in grade 1 ~ 3 adverse reactions in the study group was significantly higher than that in the control group, and the difference was statistically significant(P = 0.035 and P = 0.021, respectively). No patient experienced grade 4–5 adverse reactions. There was no significant difference in the scores of CEA, AFP, CD3+, CD4+, CD4+/CD8+, NK cells, VEGF, PDGF, KPS and QLQ-C30 between the two groups before treatment (P > 0.05), and the KPS scores were significantly higher than those before treatment, and the levels of VEGF, PDGF, CEA, AFP, CD3+, CD4+, CD4+/CD8+, NK cells and QLQ-C30 were significantly lower than those before treatment. The difference was statistically significant (P < 0.001), the CD3+, CD4+, CD4+/CD8+, NK cell levels and KPS scores in the study group were significantly higher than those in the control group, and the scores of VEGF, PDGF, CEA, AFP and QLQ-C30 were significantly lower than those in the control group, and the difference was statistically significant (P < 0.001). The treatment of TACE combined with anlotinib and sintilimab in patients with intermediate-stage unresectable hepatocellular carcinoma can effectively improve the short-term and long-term treatment efficacy, and adverse reactions can be tolerated by patients, and can effectively reduce the level of tumor markers, reduce tumor angiogenesis, improve patients’ immune function, and improve the survival rate of patients.