Multicenter randomized phase 2 trial of adjuvant sintilimab in resected high-risk hepatocellular carcinoma

Hepatocellular carcinoma (HCC), particularly when accompanied by microvascular invasion (MVI) has a high risk of recurrence after liver resection. A phase 2 trial at six centers in China evaluated the PD-1 inhibitor sintilimab as adjuvant therapy after resection for HCC with MVI. Eligible patients were randomized 1:1 to sintilimab (eight three-week cycles; n=99) or active surveillance (n=99).After a median follow-up of 23.3 months, the trial met the prespecified endpoint. Sintilimab significantly prolonged recurrence-free survival when compared to active surveillance (median 27.7 versus 15.5 months; HR 0.534; p=0.002). Patients are being followed for the endpoint overall survival. Grade 3 or 4 treatment-related adverse events occurred in 12.4% of the patients in the sintilimab group. The authors conclude that these results support the potential of immune checkpoint inhibitors as effective adjuvant therapy for these high-risk patients.