球囊阻断肝动脉灌注治疗不可切除肝细胞癌：II期临床试验中期分析
Balloon-occluded hepatic arterial infusion for unresectable hepatocellular carcinoma: a phase II trial interim analysis.
摘要(中文译文)
肝动脉灌注化疗（HAIC）越来越多地用于治疗不可切除的肝细胞癌（HCC），但部分HCC患者仍无应答或出现疾病进展。本项II期研究（ChiCTR2300077718）旨在评估基于FOLFOX方案（奥沙利铂联合氟尿嘧啶和亚叶酸钙）的球囊阻塞性肝动脉灌注化疗（bHAIC）（bHAIC-FO）在不可切除HCC中的疗效与安全性。本研究为研究者发起的多中心、单臂、前瞻性队列试验。成功接受bHAIC操作的不可切除HCC患者纳入疗效与安全性分析。在所有患者至少完成一次bHAIC术后随访后，按照预设方案进行中期分析。本中期分析的主要终点为客观缓解率（ORR）。次要终点包括甲胎蛋白（AFP）水平变化及不良事件（AE）的发生情况。中期数据采用SPSS 27.0版收集和分析。50例患者至少成功接受一次bHAIC操作并纳入疗效与安全性分析。45例可评估患者的最佳ORR按实体瘤疗效评价标准1.1版（RECIST 1.1）为53.3%，按改良RECIST（mRECIST）标准为82.2%。在患者人群中，36例初治患者按mRECIST标准获得88.9%的ORR，其中15例达到影像学完全缓解（CR）。总体而言，77.3%的AFP升高患者其AFP水平下降超过50%。所有AE均可通过药物治疗或剂量调整得到控制。bHAIC-FO在不可切除HCC治疗中显示出令人鼓舞的疗效和可接受的安全性，尤其是在初治患者中。www.chictr.org.cn，注册号ChiCTR2300077718。
Abstract
Hepatic arterial infusion chemotherapy (HAIC) is increasingly used to treat unresectable hepatocellular carcinoma (HCC), yet some HCC patients remain unresponsive or show disease progression. This phase II study (ChiCTR2300077718) aimed to assess the efficacy and safety of balloon-occluded HAIC (bHAIC) based on the FOLFOX (oxaliplatin plus fluorouracil and leucovorin) regimen (bHAIC-FO) in unresectable HCC. The present work is an investigator-initiated, multicenter, single-arm, prospective cohort trial. Unresectable HCC patients who had undergone a successful bHAIC procedure were included in the efficacy and safety analysis. After all patients received at least one post-bHAIC follow-up, an interim analysis was conducted in accordance with the predefined protocol. The primary endpoint of this interim analysis was the objective response rate (ORR). Secondary endpoints included changes in alpha-fetoprotein (AFP) levels and the occurrence of adverse events (AEs). Interim data were collected and analyzed using SPSS, version 27.0. 50 patients received at least one successful bHAIC procedure and were included in the efficacy and safety analysis. The best ORR for 45 evaluable patients was 53.3% according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) criteria, and 82.2% according to modified RECIST (mRECIST) criteria. In the patients population, 36 treatment-naive individuals achieved an 88.9% ORR according to mRECIST criteria, with 15 cases achieving radiological complete response (CR). Overall, 77.3% of patients with elevated AFP levels experienced a reduction of over 50% in their AFP levels. All AEs were manageable by medication or dose modifications. bHAIC-FO demonstrates encouraging efficacy and acceptable safety profiles in unresectable HCC treatment, particularly in treatment-naive patients. www.chictr.org.cn, identifier ChiCTR2300077718.
如何引用
AMA
Feng Li, Jian Zhang, Xiangbo An, Jianfei Liu, Benkei Li, Haiwei Li, et al. Balloon-occluded hepatic arterial infusion for unresectable hepatocellular carcinoma: a phase II trial interim analysis.. Frontiers in oncology. 2026; doi:10.3389/fonc.2026.1761615.
APA
Feng Li, Jian Zhang, Xiangbo An, Jianfei Liu, Benkei Li, Haiwei Li, et al (2026). Balloon-occluded hepatic arterial infusion for unresectable hepatocellular carcinoma: a phase II trial interim analysis.. Frontiers in oncology. https://doi.org/10.3389/fonc.2026.1761615
GB/T 7714
Feng Li, Jian Zhang, Xiangbo An, Jianfei Liu, Benkei Li, Haiwei Li, et al. Balloon-occluded hepatic arterial infusion for unresectable hepatocellular carcinoma: a phase II trial interim analysis.[J]. Frontiers in oncology, 2026 doi:10.3389/fonc.2026.1761615.
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