Donafenib plus hepatic arterial infusion chemotherapy and anti-PD-1 antibody therapies for unresectable hepatocellular carcinoma.

e16172 Background: Donafenib showed promising efficacy and safety in advanced hepatocellular carcinoma (HCC). But the efficacy of Donafenib plus hepatic arterial infusion chemotherapy (HAIC) and anti-PD-1 antibody (aPD1) therapies remained unknown. This study aimed to explore the efficacy of Donafenib-HAIC-aPD1 in unresectable HCC (uHCC). Methods: We retrospectively enrolled newly diagnosed uHCC patients in Sun Yat-sen University Cancer Center between April 2022 and July 2023. All the patients received Donafenib-HAIC-aPD1 as initial treatment. The primary outcomes evaluated in this study were progression-free survival (PFS) according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST). Secondary endpoints included overall survival (OS), objective response rate (ORR) according to mRECIST and safety. Results: Of 64 eligible patients enrolled, 59 (92.2%) were man, 51 (79.7%) were younger than 65 years, 50 (78.1%) with HBV infection. The median maximum tumor size was 8.75 cm. Multiple-intra-hepatic tumors, macrovascular invasion and extra-hepatic metastasis were recorded in 53 (82.8%), 34 (53.1%) and 11 (17.2%) patients, respectively. The median PFS per mRECIST was 12.3 months (95%CI, 7.2–17.4 months). The median OS was not reached, and 1-year OS rate was 93.2%. The ORR according to mRECIST was 73.4% and disease control rate was 93.8%. Eight (12.5%) patients conversed to received liver resection. And 4 (6.3%) patients received additional local ablation and one (1.6) received stereotactic body radiotherapy (SBRT) after major partial response. Twenty-one (32.8%) patients suffered graded 3/4 adverse events. The most frequent G3/4 adverse events were elevated AST levels (12/64, 18.8%), elevated ALT levels (9/64, 14.1%), decreased platelet count (5/64, 7.8%) and elevated total bilirubin (5/64, 7.8%). No treatment related death was observed. Conclusions: Donafenib plus HAIC and aPD1 therapies showed effective for newly diagnosed uHCC patients as first line treatment.