FOLFOX-HAIC Combined with Lenvatinib and Tislelizumab in Advanced Hepatocellular Carcinoma with Arteriovenous Fistulae: A Real-World Study

Background & Aims:​ Patients with advanced hepatocellular carcinoma (HCC) complicated by arteriovenous fistulae (AVF) face a dismal prognosis and derive limited benefit from conventional transarterial chemoembolization (TACE) due to aberrant hemodynamics. This study aimed to evaluate the efficacy and safety of FOLFOX-based hepatic arterial infusion chemotherapy (HAIC) combined with lenvatinib and tislelizumab in this treatment-refractory population. Methods:​ In this retrospective study, 51 patients with advanced HCC and angiographically confirmed AVF who received the above triple-regimen as first-line therapy were enrolled. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR) per mRECIST, AVF closure rate, and safety. Results:​ The median PFS was 9.67 months, and the median OS was 14.63 months. According to mRECIST criteria, the ORR was 72.55%, and the disease control rate (DCR) was 92.16%. The overall AVF closure rate was 87.2%. Critically, multivariate analysis identified AVF closure as an independent protective factor for improved OS (Hazard Ratio [HR] = 0.32, 95% CI: 0.13-0.78, p=0.012).​ Treatment-related adverse events were manageable, with no treatment-related deaths reported. Conclusion:​ The combination of FOLFOX-HAIC, lenvatinib, and tislelizumab demonstrates compelling efficacy by achieving a high rate of AVF closure—a key predictor of survival—along with significant survival benefits and a favorable safety profile in patients with advanced HCC and AVF, representing a novel and effective first-line therapeutic strategy.