ORIGINAL RESEARCH article
Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1667785
This article is part of the Research TopicImmunology and Therapeutic Innovations in Hepatocellular Carcinoma: Exploring Immune Evasion and BeyondView all 8 articles
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 Study
Provisionally accepted
- Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China
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Abstract Purpose: 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. Methods: 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. Results: 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 ≥3 adverse events were thrombocytopenia (16.1%) and elevated bilirubin (12.9%). Most toxicities were manageable. Conclusions: 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.
Keywords: Hepatocellular Carcinoma, DEB-TACE, TQB2450, Anlotinib, PD-L1 inhibitor
Received: 17 Jul 2025; Accepted: 18 Aug 2025.
Copyright: © 2025 Yuan, Li, Zhao, Zhao, Yao, Geng, Wang, Song and Hu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Hong-Tao Hu, Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China
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