Adjuvant camrelizumab for hepatocellular carcinoma patients with high risk of recurrence after curative hepatectomy: a retrospective multicenter study.

[BACKGROUND AND AIMS] The role of adjuvant programmed cell death-1 (PD-1) inhibitors following curative hepatectomy in patients with hepatocellular carcinoma (HCC) at high risk of recurrence remains controversial. This study aims to evaluate the efficacy and safety of camrelizumab (a PD-1 inhibitor) as adjuvant therapy in these patients.

[METHODS] This retrospective, single-arm study conducted across eight medical centers from April 2019 to January 2024 enrolled 82 HCC patients at high-risk recurrence, who received camrelizumab (200 mg) as monotherapy or in combination with tyrosine kinase inhibitors (TKIs). The primary endpoint was recurrence-free survival (RFS), while secondary endpoints included overall survival (OS) and adverse events. Propensity score matching (PSM) was utilized to adjust for potential confounders.

[RESULTS] The median follow-up duration was 27.0 months (interquartile range: 21.6-44.5). The median RFS was 28.7 months (95% confidence interval: 18.1-39.3), and the corresponding RFS rates at 12, 24, and 36 months were 68.3, 57.9, and 46.7, respectively. The median OS was not reached, with OS rates at 12, 24, and 36 months being 92.7, 90.0, and 82.1%, respectively. Among the patients, 56 received camrelizumab in combination with TKIs, while 26 received camrelizumab alone. Compared with monotherapy, combination therapy demonstrated no significant advantages in either RFS or OS. Similar results were obtained after PSM. Among all patients, the most common grade 3 or 4 adverse events were reactive cutaneous capillary endothelial proliferation (9.8%), hand-foot syndrome (4.9%), and hypertension (4.9%).

[CONCLUSION] Adjuvant camrelizumab may improve the prognosis of patients with HCC at high risk of recurrence after curative hepatectomy. Combination therapy with TKIs may be unnecessary.