Regorafenib combined with PD-1 monoclonal antibody in the second-line setting for hepatocellular carcinoma (HCC): A retrospective, real-world study in China.

e16145 Background: In China, the first-line TKI therapy for advanced HCC is a common standard treatment modality. Meanwhile regorafenib combined with anti-PD-1 antibodies (PD-1) exerted promising effects on unresectable hepatocellular carcinoma (uHCC). Still，more clinical evidence is needed to optimize second-line treatment for uHCC. In this single-center, retrospective real-world study, we look forward to further clinical benefits of regorafenib combined with PD-1 monoclonal antibody as second-line treatment of uHCC in China. Methods: We reviewed the medical data of 55 patients with HCC and received regorafenib combined with PD-1 monoclonal antibody for second-line treatment from April 2019 to April 2021. Patients were treated with regorafenib combined with PD-1 monoclonal antibody for at least 1 cycle (21days). The progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) were observed. Results: The median age was 52 years (range 29-72), 89.1% were male, 78.2% patients had hepatitis B. At study entry, the proportions of patients with Child–Pugh A/B class were 61.8%/36.4% (unknown: 1.8%); the proportions of patients with ECOG performance status 0/1/2 were 70.9%/21.8%/7.3%; the proportions of patients with BCLC stage A/B/C class were 5.5%/9.1%/83.6% (unknown: 1.8%); For prior targeted therapy, the proportion of patients with sorafenib/ lenvatinib / apatinib were 85.5%/9.1%/1.8% (unknown:1.8%), 1patient did not receive targeted therapy. Regorafenib combined with PD-1 monoclonal antibody was used for second-line systemic therapy, the PD-1s used mainly were sintilimab (n = 23), camrelizumab (n = 21), tislelizumab (n = 10); The median initial daily dose was 120 mg (rang,40-160),and the proportions of patients with the initial daily regorafenib dose 160mg/120mg/80mg/40mg were30.9%/16.4%/43.6%/1.8% (unknown :7.3%). The median PFS was 7.9 month (95%CI:5.1, NA), ORR was 27.3%, DCR was 56.4%. Conclusions: The preliminary results of this retrospective real-world study, indicate that regorafenib combined with pd-1 therapy as second-line treatment provide clinical benefits in uHCC patients with a manageable toxicity in Chinese patients. Data will be further collected to reduce bias caused by small sample size and baseline differences.