A case-control study of thermosensitive embolic agents (TempSLE) and microspheres in TACE treatment for hepatocellular carcinoma combined with hepatic arterioportal fistulas.

Abstract

e16324 Background: Hepatic arterioportal fistulas (APFs) are common in hepatocellular carcinoma (HCC). Moreover, correlated with poor prognosis, APFs often complicate anti-tumor treatments, including transarterial chemoembolization (TACE). The aim of this study was to compare the efficacy of thermosensitive embolic agents (TempSLE) and microspheres in the management of APFs and their impact on the prognosis of HCC. Methods: This is a prospective, case-control, phase II study. 92 HCC patients with APS was involved. APFs were embolized with TempSLE (group T) or microspheres (group M) during TACE. The primary outcomes were disease control rate (DCR) and objective response rate (ORR). The secondary outcomes included immediate and first follow-up APF improvement, overall survival (OS), and progression-free survival (PFS). The liver function levels, including preoperative serum albumin levels, ascites, and Child-Pugh classification, were evaluated. Results: Altogether, 92 participants were enrolled in the study, comprising 47 in group T and 45 in group M. The DCR was 93.5% and 91.1% in groups T and M, respectively (P = 0.714). The ORRs were 91.3% and 66.7% in groups E and M, respectively ( P < 0.01). The APFs improved immediately after the procedure in 45 (93.7%) patients in group T and 35 (77.8%) patients in group M ( P < 0.01). After 2 mo, APFs improvement was achieved in 42 (80.4%) and 33 (73.3%) participants in groups T and M, respectively ( P < 0.01). The OS was 26.2 ± 1.4 and 20.6 ± 1.1 mo in groups T and M, respectively (P = 0.004), whereas the PFS was 16.6 ± 1.0 and 13.8 ± 0.7 mo in groups T and M, respectively (P = 0.012). There was no ectopic embolization in group E, one mild pulmonary embolism in group M. Conclusions: Thermosensitive embolic agents demonstrated a higher efficiency rate in APFs improvement, and better ORR and longer OS and PFS in patients of HCC with hepatic APFs, represent a novel, safe, and effective approach for treating HCC combined with APFs compared to microspheres. Further studies were warranted. Clinical trial information: EC-2023-0094 .