Sintilimab as adjuvant therapy for high-risk hepatocellular carcinoma after curative resection: a multicentric retrospective cohort study.

[BACKGROUND] Current guidelines for hepatocellular carcinoma (HCC) lack standardized adjuvant therapy recommendations, particularly for patients with high-risk of recurrence after curative resection. This multicenter retrospective study aimed to evaluate the efficacy and safety of adjuvant sintilimab (a programmed death protein-1 inhibitor) in this underserved population.

[METHODS] Patients with high-risk recurrence factors after curative resection were enrolled from five medical centers. All patients received sintilimab (200 mg), with or without tyrosine kinase inhibitors (TKIs). The primary endpoint was recurrence-free survival (RFS), with secondary endpoints including overall survival (OS).

[RESULTS] A total of 101 patients were included. The median RFS was 32.1 months [95% confidence interval (CI): 12.9-51.1], with 1-, 2-, and 3-year RFS rates of 73.1, 58.3, and 49.4%, respectively. Median OS was not reached, with 1-, 2-, and 3-year OS rates of 90.1, 83.0, and 76.2%, respectively. No significant differences in RFS (hazard ratio: 0.75, 95% CI: 0.40-1.40) or OS (hazard ratio: 0.65, 95% CI: 0.26-1.62) were observed between patients with ( n  = 34; 33.7%) or without TKIs ( n  = 67; 66.3%). In addition, no significant difference in RFS (hazard ratio: 0.97, 95% CI: 0.50-1.86) or OS (hazard ratio: 0.54, 95% CI: 0.19-1.53) was found between patients receiving adjuvant therapy for up to 6 months versus longer than 6 months.

[CONCLUSION] These findings support the potential of 6 months sintilimab monotherapy or in combination with TKIs as an effective adjuvant therapy for patients with HCC at high risk of recurrence. Further large-scale randomized controlled trials should be warranted.