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

Pengen Li,1 Shumin Fu,1 Xiao Wang,1 Yi Chen,2 Jianbing Wu,1 Weimin Jiang,1 Ye Mao11Department of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, 330006, People’s Republic of China; 2Department of Hepatobiliary Surgery, The Second Affiliated Hospital of Nanchang University, Nanchang, 330006, People’s Republic of ChinaCorrespondence: Ye Mao, Email rayooocat111@163.comBackground and Aims: Patients with advanced hepatocellular carcinoma (HCC) complicated by arteriovenous fistula (AVF) often fail to benefit from conventional transarterial chemoembolization (TACE) because of the associated hemodynamic abnormalities, resulting in an extremely poor prognosis. This retrospective, single-center, single-arm study was conducted to preliminarily evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) using the FOLFOX regimen in combination with lenvatinib and tislelizumab in this population of patients with unresectable/advanced HCC.Methods: A total of 51 patients with advanced HCC complicated by angiographically confirmed AVF, who were treated at our institution between December 2020 and May 2025, were retrospectively enrolled. All patients received the aforementioned triple-therapy regimen as first-line treatment. The primary endpoint was progression-free survival (PFS), while secondary endpoints included overall survival (OS), objective response rate (ORR), fistula closure rate, and safety.Results: The median PFS and OS were 9.67 months and 14.63 months, respectively. According to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), the ORR and disease control rate (DCR) were 72.55% and 92.16%, respectively. The overall AVF closure rate was 87.2%, and time-dependent covariate Cox regression analysis identified fistula closure as an independent protective factor for OS. Treatment-related adverse events (TRAEs) were manageable, and no treatment-related deaths occurred.Conclusion: This real-world study demonstrates that FOLFOX-based HAIC combined with lenvatinib and tislelizumab is associated with a high AVF closure rate, favorable survival outcomes, and a manageable safety profile in patients with unresectable/advanced HCC complicated by AVF. This combination regimen may offer a feasible therapeutic strategy for this refractory patient population; Meanwhile, we anticipate that prospective controlled studies will further consolidate and extend the current findings, so as to establish their clinical value in a more comprehensive manner.Keywords: hepatocellular carcinoma, arteriovenous fistula, hepatic arterial infusion chemotherapy, lenvatinib, tislelizumab