{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T04:29:43Z","timestamp":1774412983229,"version":"3.50.1"},"reference-count":31,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p>Advanced hepatocellular carcinoma (HCC) remains difficult to treat due to high tumor burden and limited systemic options. This study evaluated the efficacy and safety of drug-eluting bead transarterial chemoembolization (DEB-TACE) combined with intra-arterial infusion of PD-L1 inhibitor TQB2450 and oral Anlotinib as first-line treatment in patients with advanced HCC.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this prospective, single-arm phase 2 trial, 31 patients with BCLC stage C HCC received DEB-TACE, transarterial infusion of TQB2450 (1200 mg every 3 weeks), and oral Anlotinib (12 mg\/day, 2 weeks on\/1 week off). Tumor responses were assessed using mRECIST criteria. Primary endpoint was objective response rate (ORR); secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The ORR was 54.5%, with 3 patients (9.7%) achieving complete response. The median PFS and OS were 5.1 and 9.6 months, respectively. The most common grade \u22653 adverse events were thrombocytopenia (16.1%) and elevated bilirubin (12.9%). Most toxicities were manageable.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This triple-combination therapy demonstrated potentially beneficial antitumor activity and an acceptable safety profile in patients with advanced HCC. These findings support further investigation in randomized controlled trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical trial number<\/jats:title><jats:p>Chinese Clinical Trials Database (ChiCTR2200056222).<\/jats:p><\/jats:sec>","DOI":"10.3389\/fimmu.2025.1667785","type":"journal-article","created":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T05:29:33Z","timestamp":1756704573000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy and safety of DEB-TACE combined with transarterial TQB2450 infusion and oral Anlotinib as first-line treatment in advanced hepatocellular carcinoma: a single-arm phase II 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