Abstract: Objective To investigate the efficacy and safety of DEB-TACE combined with lenvatinib in the treatment of unresectable advanced hepatocellular carcinoma (HCC). Methods Seventy patients with unresectable advanced HCC admitted to the Department of Oncology, Haian People's Hospital from January 2021 to March 2022 were randomly divided into an observation group and a control group. On the basis of oral lenvatinib, the observation group was treated with DEB-TACE, and the control group was treated with iodized oil hepatic arterial chemoembolization (cTACE). The changes of tumor internal environment and liver function indexes, as well as the efficacy and safety indexes were observed before and after treatment. Results The 3-month objective response rate (ORR), disease control rate (DCR) and 1-year survival rate of the observation group were 77.14%, 91.43% and 57.14%, respectively, which were higher than those of 54.29%, 71.43% and 37.14% in the control group. The 1-year recurrence rate of the observation group was 20.00%, which was lower than that of the control group (42.86%), and the difference was statistically significant (χ²=4.086, 3.695, 3.369, 4.879, all P<0.05). After 3 months of treatment, the serum levels of hypoxia-inducible factor-1α (HIF-α), tumor-specific growth factor (TSGF) and hepatocyte growth factor (HGF) in the observation group were 308.47±32.65 pg/mL, 54.36±5.81 U/mL, and 4.37±0.83 μg/L, respectively. They were lower than those of 382.45±38.39 pg/mL, 63.49±6.34 U/mL, and 5.08±0.96 μg/L in the control group, and the differences were statistically significant (t=7.516, 8.342, 8.754, all P<0.05). The serum alanine aminotransferase (ALT) and total bilirubin (TBil) levels in the observation group were 58.83±6.73 U/L and 21.69±3.12 μmol/L, respectively, which were lower than those of 72.56±7.45 U/L and 23.25±3.18 μmol/L in the control group, whereas the albumin (Alb) level in the observation group was 34.56±2.37 g/L, which was higher than that of 32.89±2.29 g/L in the control group, and the differences were statistically significant (t=5.163, 4.746, 3.725, all P<0.05). The incidence of adverse reactions in the observation group was slightly lower than that in the control group, without statistical significance (P>0.05). Conclusion DEB-TACE combined with lenvatinib in the treatment of unresectable middle and advanced HCC can improve the internal environment of tumor lesions, reduce liver damage, and improve clinical treatment effect with high safety.

Key words: Hepatocellular Carcinoma, DEB-TACE, Tumor microenvironment, Lenvatinib, Security