Efficacy and Safety of Thermosensitive Hydrogel Combined with Pirarubicin via TACE for Hepatocellular Carcinoma: A Pilot Study.
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AIM: This pilot study aims to evaluate the technical feasibility, safety profile, and preliminary efficacy of Tepoxin, a thermosensitive hydrogel, combined with pirarubicin via transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (HCC), providing foundational data for future larger-scale trials. METHODS: This is a single-center, retrospective, single-arm pilot study including 7 HCC patients who received Tepoxin combined with pirarubicin TACE between 2023 and 2025. Inclusion criteria were: confirmed HCC by imaging or pathology, Child-Pugh A-B liver function, ECOG performance status ≤ 2, and no severe comorbidities. The procedure involved selective hepatic artery catheterization to deliver pirarubicin-loaded hydrogel for embolization. Primary endpoints were procedure success rate, adverse events, tumor response (evaluated by changes in the maximum tumor diameter and mRECIST criteria for PR/SD/PD), and disease control rate (DCR). Follow-up was conducted for at least 4-6 weeks for preliminary imaging assessment. RESULTS: All 7 patients completed the procedure without failure or discontinuation. Tumor response was assessable in all patients: 2 achieved partial response (PR), 4 had stable disease (SD), and 1 had progression (PD). The objective response rate (ORR) was 28.6% (2/7), and the disease control rate (DCR) was 85.7% (6/7). Adverse events were mild, including fever, abdominal pain, and nausea/vomiting (grade 1-2), with no severe toxicity (grade ≥3) or treatment interruption. Mild liver function fluctuations were observed in some patients, which recovered to baseline. CONCLUSION: Tepoxin combined with pirarubicin TACE is technically feasible and well-tolerated in HCC patients, showing early anti-tumor activity. Larger, well-designed studies are needed to confirm its efficacy and safety.