Liver Transplantation After Combination Therapy Based on Immune Checkpoint Inhibitors: A Multicenter Retrospective Study of Safety and Efficacy

ABSTRACT Background Perioperative use of immune checkpoint inhibitors (ICIs) in patients with hepatocellular carcinoma (HCC) undergoing liver transplantation (LT) remains controversial, primarily because of concerns regarding allograft rejection. The present study evaluated the safety and potential efficacy of ICIs as a downstaging or bridging therapy prior to LT. Methods This multicenter retrospective analysis included 17 patients with HCC from six Chinese centers who received at least one cycle of preoperative ICI therapy followed by LT. Results The cohort had a mean age of 51.1 ± 9.9 years; 94.1% were men. Disease stages were Barcelona Clinic Liver Cancer Stage A ( n = 2), B ( n = 10), and C ( n = 5). All patients received multimodal therapy combining ICIs (sintilimab, n = 13; tislelizumab, n = 2; atezolizumab, n = 1; and pembrolizumab, n = 1) with locoregional and/or systemic treatments. In accordance with the Response Evaluation Criteria in Solid Tumors 1.1 criteria, the objective response rate was 76.5% (13/17), comprising 1 complete response and 12 partial responses. Following LT, all patients received a tacrolimus‐based immunosuppressive regimen. Over a median follow‐up of 11.4 months, no indications of graft rejection and no tumor recurrence were observed. Conclusion In the study cohort, preoperative ICI‐based therapy was not associated with an increased risk of rejection, suggesting its short‐term safety in the context of LT for HCC. Larger prospective studies are warranted to validate these findings and to further define the efficacy and safety profile of this approach.