Efficacy and safety of donafenib combined with interventional therapy and with/without immunotherapy in hepatocellular carcinoma: A retrospective study.

Abstract

e16177 Background: The Phase III clinical trial ZGDH 3 and several real-world studies have demonstrated the potential of Donafenil to improve overall survival (OS) in HCC patients. This study evaluated the efficacy and safety of donafenil combined with intervention ±PD-1 in the treatment of HCC by retrospective analysis of previous patient information. Methods: We retrospectively analyzed patients with hepatocellular carcinoma who received Donafinil combination therapy at Peking University Cancer Hospital between April 2022 and December 2024, all of whom received at least 1 cycle of therapy. The primary endpoint was objective response rate (ORR), and secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. Results: 32 patients were included, all of whom received donafenil combined with intervention ±PD-1.First-line treatment accounted for 78.1%, and post-line treatment accounted for 21.9%. In the past, 13 patients (40.6%) had undergone interventional therapy, 5 patients (15.6%) had undergone surgery, and 6 patients (18.8%) had undergone radiofrequency ablation. Patients were classified as BCLC stage 0 (3.1%), A (21.9%), B(37.5%) and C(37.5%). The median tumor size was 5.3 cm (range 1.0, 16.7), 23 patients (71.9%) had ≥2 tumors, and 17 patients (53.1%) had ≥5 cm tumors. The median follow-up was 7.6 months, and 9 patients died. The ORR was 56.3% and DCR was 81.3%( CR 9 [28.1%], PR 9 [28.1%]) .The mRFS was 16.1 months, mOS was 23.3 months, 12-month rate was 75.1%, 12-month OS rate 85%. Most of all treated patients had at least one TEAEs (90.6%). 10 patients (31.2%) had grade 3 and above TEAEs, and no grade 4 or 5 TEAE or treatment-related deaths were reported. TEAEs with an incidence of > 20% included elevated total bilirubin, elevated ALT, elevated AST, and decreased platelet count. Conclusions: Donafenib combined interventional therapy with ±PD-1 has shown good efficacy and safety in HCC patients.