Efficacy and safety of regorafenib combined with immune checkpoint inhibitors in advanced hepatocellular carcinoma patients progressing after lenvatinib treatment.

e16170 Background: Advanced hepatocellular carcinoma (HCC) has a robust array of first-line treatment options, including various targeted therapies and immunotherapy combinations. However, second-line treatment choices remain limited, and there is insufficient evidence regarding the efficacy and safety of therapies for patients who progress after first-line treatments. Regorafenib is primarily indicated for patients who progress after first-line sorafenib treatment, and its effectiveness and safety in patients previously treated with lenvatinib have not been thoroughly explored. This study aims to evaluate the efficacy and safety of regorafenib combined with immune checkpoint inhibitors (ICIs) in patients with advanced HCC who have progressed after lenvatinib treatment. Methods: This is a single-center retrospective study that included patients with advanced HCC who had received lenvatinib and ICIs as first-line treatment. The primary endpoints were progression-free survival (PFS) and overall survival (OS); secondary endpoints included objective response rate (ORR) and disease control rate (DCR). Data collection encompassed baseline characteristics, treatment efficacy assessments, and adverse event (AE) occurrences. Results: A total of 51 patients were included, with 86.3% being male. The median age was 53 years, and the median follow-up time was 15.42 months. The median PFS was 5.46 months (95% CI: 3.067-7.853), while the median OS was 15.09 months (95% CI: 10.905-19.275. Treatment response assessment revealed 10 complete response (CR), 7 partial responses (PR), 12 stable disease (SD), and 21 progressive disease (PD), resulting in an ORR of 34% and a DCR of 58%. Adverse events were reported in 98% of patients, with the most common being hand and foot syndrome, increased liver enzymes, and fatigue. Notably, 31.3% of patients required dose adjustments of regorafenib due to treatment-related adverse events. Conclusions: Regorafenib combined with ICIs demonstrates promising efficacy and acceptable safety in patients with advanced HCC who have progressed after lenvatinib treatment. This study provides reference data that may inform clinical treatment choices for this patient population.