Selective Conventional Transarterial Chemoembolization Using a Glass Membrane Emulsification Device in Hepatocellular Carcinoma: Multicenter Clinical Trial in Japan.

Objective: The aim of the study was to evaluate the complete response (CR) rate achieved with selective conventional transarterial chemoembolization (cTACE) using a porous glass membrane emulsification device in hepatocellular carcinoma (HCC). Methods: In a multicenter phase II trial (jRCTs052200095) conducted between January 2021 and June 2023, 50 patients with unresectable HCC (tumor diameter ≤5 cm; Child-Pugh A or B) were enrolled. An emulsion of epirubicin and ethiodized oil (Lipiodol) prepared using the emulsification device was injected into the tumor-feeding arteries, followed by embolization with gelatin sponge particles. The primary endpoint was the CR rate at 3 months post-treatment. Secondary endpoints included the CR rate at 1 month and the incidence of adverse events. Outcomes were compared with a historical control cohort from the JIVROSG-1302 study in exploratory analyses. Results: Two patients were excluded after enrollment, leaving 48 patients who received cTACE (safety set). An additional 3 patients were excluded post-treatment, yielding 45 patients for efficacy analysis. The CR rate at both 1 month and 3 months was 97.8% (95% confidence interval: 88.2-99.9%). Serious adverse events (grade ≥3) included elevated AST in 50.0% of patients, elevated ALT in 29.2%, thrombocytopenia in 2.1%, and elevated ALP in 2.1%. The proportion of patients with deterioration in ALBI grade (≥1 grade increase) at 3 months was 17.8%. In exploratory analyses, CR rates were numerically higher than those observed in the historical control. Conclusion: Selective cTACE using a W/O emulsion prepared with a glass membrane pumping emulsification device was associated with high short-term CR rates in patients with HCC, with an acceptable safety profile. These findings support further clinical investigation.