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.

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. Clinical trial number: Chinese Clinical Trials Database (ChiCTR2200056222).