Abstract: Objective To investigate the efficacy and safety of carrellizumab on tumor progression in patients with unresectable hepatocellular carcinoma (HCC) after the treatment of drug-loaded microspheres of hepatic artery chemoembolization (DTACE) and sorafenib. Methods Fifty-six advanced patients with unresectable HCC treated with DTACE in combination with sorafenib from January 2020 to December 2021 in Haian People’s Hospital and Wuhan Fourth Hospital were selected and randomly divided into an observation group and a control group. The control group continually received DTACE treatment in combination with sorafenib. The observation group was additionally treated with carrilizumab. All with intolerable TRAE, or disease re-progression, or follow-up till deadline as the course of treatment. Both groups of patients were observed and compared about their objective response rate (ORR) and disease control rate (DCR) in 3 months after treatment, their overall survival (OS) and progression-free survival (PFS) at follow-up deadline, the changes in tumor markers and liver function indicators before and after the treatments, and the incidence of chemotherapy-related adverse events (TRAE). Results In three months after treatment, the conversion operation rate, ORR, DCR, OS and PFS in the observation group were 17.86%, 57.14%, 82.14%, 13.83±2.24 months and 8.38±1.56 months, respectively, which were higher than those of 7.14%, 35.71%, 60.71%, 9.75±1.79 months and 6.36±1.27 months in the control group, with statistical significance (χ²=4.039, 3.853, 3.481, t=8.273, 8.015, all P<0.05). After 3 months of treatment, the serum levels of alpha-fetoprotein anisoplast 3 (AFP-L3), α-L-fucoidase (AFU) and tumor-specific growth factor (TSGF) in the observation group were 47.19±11.84 mg/L, 34.39±5.08 U/L and 52.30±5.84 U/mL, respectively, which were significantly lower than those of 80.35±16.72 mg/L, 51.46±7.35 U/L and 63.47±6.37 U/mL in the control group (t=9.514, 8.392, 8.315, all P<0.05). Serum alanine aminotransferase (ALT), γ-glutamyl transpeptidyase (γ-GT) and total bilirubin (TBil) were 59.46±5.28 U/L, 61.69±5.47 U/L and 19.26±3.05 μmol/L, respectively, which were significantly lower than those of 74.08±6.04 U/L, 76.25±6.29 U/L and 24.41±3.83 μmol/L in the control group (t=7.416, 7.395, 6.735, all P<0.05). The TRAE in both groups were level 1~2, and there was no significant difference between the two groups (P>0.05). Conclusion Carrilizumab can improve the efficacy of DTACE in combination with sorafenib treatment to prevent tumor progression in patients with unresectable HCC, which benefits the patients with safety and controllability.

Key words: Hepatocellular carcinoma, Drug-loaded microspheres of hepatic artery chemoembolization, Tumor microenvironment, Tumor progression, Carrellizumab, Chemotherapy-related adverse events