e16182 Background: The treatment of unresectable hepatocellular carcinoma (uHCC) remains challenging. Although the combination of multiple effective therapeutic modalities, including transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), and donafenib-based targeted therapy, has been shown to enhance tumor control, careful balancing of efficacy and safety is essential when integrating these approaches. This real-world study evaluated the efficacy and safety of TACE combined with HAIC and low-dose donafenib in patients with uHCC. Methods: This ongoing real-world study enrolled patients diagnosed with uHCC who received first-line therapy consisting of TACE-HAIC plus donafenib (100 mg twice daily) at Henan Cancer Hospital.The primary endpoint was ORR assessed according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST). Secondary endpoints included overall survival (OS), PFS, disease control rate (DCR), time to untreatable (unTACEable) progression (TTUP), and treatment-related adverse events (TRAEs). Results: Between Sep 4,2024 to Oct 30, 2025, 32 patients were enrolled and treated. Among all patients, median age was 61 years, 26 (81.2%) had HBV, 17 (53.1) had multiple tumors, 18 (56.3%) were at BCLC stage C. The median number of TACE sessions per patient was 2 (range: 1–6). Notably, 31 patients (96.9%) also received concomitant immunotherapy (ant–PD-1 antibodies). As of data cutoff (Dec 30, 2025), the median follow-up was 9.3 months. Median PFS and Median OS were not reached.The estimated 12-month PFS rate was 87.5% and Estimated 12-month OS rate was 91.7%. Based on the mRECIST criteria, the best ORR and DCR were 81.2% and 100% (11 of complete response CR, 15 of partial response PR, and 6 of stable diseaseSD) . The CR rate was 34.4%. Notably, the median time to response of 1.57 months indicated rapid therapeutic onset. Among the 32 evaluable patients, 26 patients (81.3%) maintained or improved ALBI grading at the end of treatment. The change of ALBI score from baseline to the end of treatment were -2.28 to -2.18 (p = 0.25). Grade 3 or 4 TRAEs were observed in 17 (53.1%) patients, and no treatment-related deaths occurred. The most common AEs were thrombocytopenia (75.0%), anemia (68.7%), elevated ALT (62.5%). Conclusions: TACE combined with HAIC and low-dose donafenib showed encouraging antitumor activity with a manageable safety profile in uHCC patients. This regimen may be a feasible first-line treatment option and warrants further evaluation in prospective studies. Clinical trial information: ChiCTR2400089110.
Xia et al. (Thu,) studied this question.