Abstract: Objective The aim of this study was to explore the efficacy and safety of camrelizumab and lenvatinib combination in the treatment of patients with advanced primary liver cancer (aPLC). Methods 78 patients with aPLC were enrolled in our hospital between April 2019 and April 2021, and were randomly divided into control (n=39) and observation group (n=39), receiving camrelizumab or camrelizumab and lenvatinib combination therapy until progression of the disease or death. The Objective response rate (ORR) and disease control rate (DCR) were recorded. Serum alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA) and carbohydrate antigen 199 (CA199) levels were detected by chemiluminescence immunoassay. The survival analysis was conducted by Kaplan-Meier method. Results After treatment, the ORR and DCR in the observation group were 56.4% and 92.3%, much higher than 33.3% and 74.4%(P<0.05)in the control; serum AFP level in the observation group was (78.9±17.4) ng/ml, much lower than [(152.6±31.5)ng/ml, P<0.05] in the control; at the end of two-year follow-up, the mean progression free survival(PFS) in the observation and control groups were 16.2 mon and 12.3 mon, the PFS rates were 38.5% and 25.6%(P＞0.05), and the mean overall survival (OS) were 20.3 mon and 16.0 mon, with the OS rates of 61.5% in the observation, much greater than 38.5% (P<0.05) in the control; during the treatment period, the incidence rates of rash, fatigue, anorexia, hypertension and urinary protein positive in the observation group were 12.8%, 17.9%, 10.3%, 7.7% and 7.7%, all not significantly different compared to 10.3%, 20.5%, 7.7%, 7.7% and 5.1% (P＞0.05), while the incidence of reactive capillary hyperplasia in the observation group was 12.8%, which didn’t occurred in the control group. Conclusion The administration of camrelizumab and lenvatinib combination in the treatment of patients with unresectable PLC has to some extent a short-term and long-term efficacy, and the adverse reactions are endurable.

Key words: Hepatoma, Advanced, Camrelizumab, Lenvatinib, Therapy