Adjuvant HAIC combined with anlotinib and TQB2450 for resected high-risk hepatocellular carcinoma

In this single-arm, phase 2 study, we explored the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) combined with anlotinib and TQB2450 (an anti-PD-L1 antibody) as a postoperative adjuvant treatment in patients at high risk of hepatocellular carcinoma (HCC) recurrence. Patients with high-risk recurrence of HCC were treated with HAIC, anlotinib (4 or 8 cycles), and TQB2450 after curative surgery. The primary endpoint was disease-free survival (DFS), and the secondary endpoints included overall survival (OS) and safety. 77 patients who met the inclusion criteria were enrolled: 38 in the 4-cycle cohort and 39 in the 8-cycle cohort. As of the data cutoff on June 24, 2024, the median follow-up period was 21.19 months (95% confidence interval [CI], 20.49-21.89). The median DFS and OS of all patients were not reached. 1-year and 2-year DFS rates were 84.4% and 65.8%, respectively, while 1-year and 2-year OS rates were 96.1% and 89.8%, respectively. No significant differences in DFS and OS were observed in patients treated with 4 or 8 cycles of anlotinib. The incidence of grade 3/4 adverse events (AEs) was 28.6%. Postoperative adjuvant HAIC combined with anlotinib and TQB2450 demonstrated encouraging clinical benefits in reducing recurrence with manageable toxicities in patients at high risk of HCC recurrence. 4-cycle anlotinib combined with HAIC and TQB2450 is recommended as an adjuvant treatment for further investigation.