Hepatic artery infusion chemotherapy (HAIC) combined with tislelizumab and lenvatinib for initial unresectable hepatocellular carcinoma (HCC) with portal vein tumor thrombus: A prospective, single-arm phase II trial.

作者：Long Pan, Ruirui Sun, Qiang He, Yin Zhou, Jiachu Li, Yang Gou, Chenrui Wu, Zixuan Fu, Yaowu Zhao, Qin He, Ping Huang · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.2024.42.16_suppl.4103 · 被引用次数：4 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cancer Mechanisms and Therapy、Liver Disease and Transplantation

4103 Background: The combination of immune checkpoint blockade and multikinase inhibitor has been proven to improve clinical outcomes of advanced HCC. Hepatic arterial infusion chemotherapy is an intra-arterial procedure that has been widely used in Asia, with high response rate. The aim of this trial was to evaluate the efficacy and safety of HAIC combined with tislelizumab and lenvatinib for initial unresectable HCC with portal vein tumor thrombus (PVTT). Methods: This is a prospective, single-arm phase II study. Patients with histologically or cytologically diagnosed or clinically confirmed hepatocellular carcinoma and accompanied by PVTT, no previous systemic treatment were eligible for inclusion. Patients received HAIC(FOLOFOX), combined with intravenous tislelizumab (200mg, q3w) and lenvatinib (8/12mg, qd) for six cycles, followed by maintenance therapy with tislelizumab and lenvatinib until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) per RECIST 1.1 and mRECIST. Results: Between Sep, 2021 to Nov, 2023, a total of 29 eligible patients were enrolled and evaluable for efficacy analyses: median age 54 years (M/F:25/4; CNLC stage IIIa/IIIb: 24/ 5). Portal vein tumor thrombus PVTT Ⅰ-Ⅱ/PVTT Ⅲ-Ⅳ:19/10. An average of 4.35 times of HAIC were underwent in these patients. With a median follow-up of 11 months (interquartile range [IQR] 7.5-21.5), the confirmed ORR was 68.97% (95%CI 49.19-84.72)and 58.62%(95%CI 38.94-76.48)per ...