Liver Cancer · Published 2026-07-10 · DOI 10.1159/000552424
Toshihiro Tanaka, Hiroshi Anai, Tetsuya Masada, Satoru Sueyoshi, Takeshi Sato, Shohei Toyoda, Takeshi Matsumoto, Yuto Chanoki, Keisuke Oshima, Sho Shimizu, Mariko Irizato, Ryosuke Taiji, Kiyoyuki Minamiguchi, Hideki Kunichika, Hiroyuki Kurakami, Shigeo Ichihashi, Hideyuki Nishiofuku
<p>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. </p>
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Tanaka, T., Anai, H., Masada, T., et al. (2026). Selective Conventional Transarterial Chemoembolization Using a Glass Membrane Emulsification Device in Hepatocellular Carcinoma: Multicenter Clinical Trial in Japan. Liver Cancer. https://doi.org/10.1159/000552424