Transarterial Embolization Alone Versus Drug-Eluting Microspheres Chemoembolization for Hepatocellular Carcinoma (RAD-18-TAcE): A Multicenter Randomized Clinical Trial

PURPOSE: To compare transarterial embolization (TAE) and drug-eluting microspheres transarterial chemoembolization (DEM-TACE) in the treatment of hepatocellular carcinoma (HCC) through a non-inferiority randomized clinical trial. MATERIALS AND METHODS: Patients diagnosed with unresectable HCC were randomly assigned to either the TAE or DEM-TACE group. The primary endpoint was time to progression (TTP), and secondary endpoints included overall survival, hospitalization stay, tumor response rates, and severe adverse events (SAE). RESULTS: At the end of the trial, a total of 111 patients (56 TAE and 55 DEM-TACE) were enrolled between 2019 and 2022. The median TTP was similar between TAE and DEM-TACE (7.56 vs. 7.98 months, p = 0.432). In patients with confirmed disease progression, the mean TTP was 6.68 vs. 8.43 months for TAE and DEM-TACE, respectively, with a mean difference of 1.75 months (95% CI - 1.47-4.97), falling within the predefined equivalence range; two one side test (TOST) analysis confirmed equivalence (p < 0.001 and p = 0.022 for lower and upper bounds. Overall survival, tumor response rates, and adverse events were also not statistically different between groups (p > 0.05 for each outcome). Finally, Days of hospitalization were not statistically different (median 4 days for both arms, p = 0.638). CONCLUSION: TAE and DEM-TACE had comparable results in the treatment of early and intermediate stage unresectable HCC.