Adjuvant benmelstobart plus anlotinib in patients with high-risk recurrence after resection of hepatocellular carcinoma: a phase II study (ALTER-H006).

This phase II study (ALTER-H006; NCT05111366) evaluates adjuvant benmelstobart plus anlotinib in patients with high-risk recurrence (including ≥4 tumors, portal vein tumor thrombus [Vp1/2], or hepatic vein tumor thrombus [Vv1/2]) after hepatocellular carcinoma (HCC) resection. Primary endpoint is 1-year recurrence-free survival (RFS) rate. Secondary endpoints include overall survival (OS), 1-year OS rate, RFS, and safety. Median follow-up is 12.6 months. Among 37 patients enrolled, 1-year RFS rate is 59.7%, and median RFS is 15.6 months. Subgroups with Vp1/2 and Vv1/2 show median RFS of 18.2 months and not reached (NR), respectively. The longest recurrence-free duration is 25.9 months. Median OS is NR (1-year OS rate, 91.7%). Grade ≥3 treatment-related adverse events occur in 45.9% of patients, most commonly hypertension. No treatment-related deaths occur. Here, we show that adjuvant benmelstobart plus anlotinib is a feasible treatment option for HCC patients with high-risk recurrence after HCC resection, warranting confirmation in large-scale randomized clinical trials.