Abstract: Objective To explore the efficacy and safety of transarterial chemoembolization (TACE) combined with camrelizumab and lenvatinib in the treatment of unresectable hepatocellular carcinoma (HCC). Methods Eighty-six HCC patients treated at our hospital from March 2019 to March 2021 were selected as the study sample and randomly divided into two groups. The control group (n=43) received TACE alone, while the experimental group (n=43) underwent TACE combined with lenvatinib and camrelizumab. The efficacy, tumor marker levels [serum alpha-fetoprotein (AFP), abnormal prothrombin (PIVKA-Ⅱ), carbohydrate antigen 199 (CA199), and carcinoembryonic antigen (CEA)], maximum tumor diameter after treatment, survival status, and adverse reactions (liver function damage, thyroid dysfunction, hypertension, gastrointestinal bleeding, anemia, leukopenia) were compared between the two groups. Results The experimental group demonstrated superior clinical outcomes, with anObjective response rate (ORR) of 39.5% and a disease control rate (DCR) of 81.4%, compared to 18.6% and 55.8% in the control group, respectively (χ²=4.568, 6.532; P=0.033, 0.011). Serum levels of AFP, PIVKA-Ⅱ, and CA199 in the experimental group were (78.9 ± 17.4) ng/mL, (41.7 ± 10.4) ng/mL, and (18.0 ± 4.8) kU/L, respectively, which were significantly lower than those in the control group [(152.6±31.5) ng/mL, (85.4 ± 18.4) ng/mL,(24.1 ± 4.7) kU/L] (t=17.233, 12.855, 6.188; P<0.05). The average maximum tumor diameter was significantly smaller in the experimental group [(4.61 ± 0.5) cm] than in the control group [(6.23 ± 0.8) cm] (t=10.551; P<0.05). After two years of follow-up, the median progression-free survival (PFS) in the experimental group was 17.5 months, compared to 13.8 months in the control group. Although the difference in PFS rate (39.5% vs. 27.9%) was not statistically significant (P>0.05), the experimental group demonstrated a significantly longer median overall survival (OS) of 21.2 months versus 17.2 months in the control group, with OS rate also higher (65.1% vs. 50.0%) (P<0.05). The incidence of gastrointestinal adverse events was lower in the experimental group (13.9%) than in the control group (37.2%) (χ²=6.108; P=0.013). Conclusion The combined therapy of TACE with camrelizumab and lenvatinib for patients with unresectable hepatocellular carcinoma has shown potential to significantly enhance treatment effects, reduce tumor marker levels, decrease maximum tumor diameter, significantly improve overall survival, and is controllable in terms of adverse reactions, presenting a promising clinical application prospect.

Key words: Hepatocellular carcinoma, Transarterial chemoembolization, Camrelizumab, Lenvatinib, Unresectable