Transarterial chemoembolization plus donafenib with or without anti-PD-1 antibodies for unresectable hepatocellular carcinoma: A retrospective study.

e16245 Background: Transarterial chemoembolization (TACE) can effectively reduce tumor burden by delivering chemotherapy drugs directly to the tumor while simultaneously blocking its blood supply. Donafenib, a novel multi-kinase inhibitor, showed promise in inhibiting tumor growth and angiogenesis. Combining TACE with donafenib may enhance local and systemic control of unresectable hepatocellular carcinoma (uHCC). This study aimed to evaluate the efficacy and safety of TACE combined with donafenib for uHCC patients in a real-world setting. Methods: This single-center, retrospective study was performed from May 2021 to September 2024 at The First Affiliated Hospital of Sun Yat-sen University. Patients diagnosed with uHCC who had received TACE plus donafenib with or without anti-PD-1 antibodies (TACE+Dona or TACE+Dona+PD-1) as the first-line therapy were included. The primary endpoint was 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), disease control rate (DCR) and adverse events. Results: In total, 140 consecutively recruited patients were reviewed, 101 of whom were eligible for the study (TACE+Dona, n = 37; TACE+Dona+PD-1, n = 64). Among all patients, median age was 59 years, 89 (88.1%) had HBV, 77 (76.2) had multiple tumors, 62 (61.4%) were at BCLC stage C, 53 (52.5%) presence hepatic venous invasion, median maximum tumor diameter was 7.0 cm (IQR, 4.2-10.2), and median number of TACE sessions per patient was 2 (range, 1-9 sessions). Up to the date of December 30, 2024, the median follow-up was 14.3 months. The median PFS and OS were 10.4 months (95%CI, 8.9-15.7) and 33.5 months (95%CI, 21.4-NA), respectively. The ORR was 72.3%, and DCR was 95.0% (14 of complete response, 59 of partial response, and 23 of stable disease) per mRECIST. Grade 3 or 4 treatment-related adverse events (TRAEs) were observed in 17 (16.8%) patients, and no treatment-related deaths occurred. The most common AEs greater than 10% were hand-foot skin reaction (15.8%), and rash (12.9%). Conclusions: TACE plus donafenib with or without anti-PD-1 antibodies showed encouraging antitumor activity and manageable safety, which maybe a potential regimen option for uHCC.