BackgroundMore than half of neuroendocrine tumor (NET) patients will experience liver metastasis, and interventional therapy represented by transarterial embolization (TAE) is the main local treatment method. Surufatinib is recommended as a standard systemic treatment for advanced NETs. The efficacy and safety of surufatinib combined with TAE in the treatment of liver metastasis are undetermined. This study was conducted to compare the clinical outcome of surufatinib combined with TAE versus surufatinib monotherapy in liver metastatic NETs.MethodsThis is a prospective, multicenter, open‐label, and randomized controlled trial. Patients diagnosed with liver metastatic NETs will be enrolled. Participants are randomly assigned in a 1:1 ratio to either the experimental group or the control group. Patients will be treated with surufatinib plus TAE in the experimental group, while patients in the control group will receive surufatinib monotherapy. The primary endpoint is progression‐free survival (PFS) assessed by a blinded independent image review committee (BIIRC). The secondary endpoints are investigator‐assessed PFS, liver‐specific objective response rate (ORR), objective response rate (ORR), disease control rate (DCR), overall survival (OS), and incidence of adverse events.DiscussionThis is the first prospective study to investigate the efficacy of surufatinib combined with TAE. We expect this trial to propose a new and effective treatment strategy for liver metastatic NETs.

中文翻译：

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索凡替尼联合经动脉栓塞与索凡替尼单药治疗肝转移性神经内分泌肿瘤：一项前瞻性、随机、对照试验的研究方案

背景一半以上的神经内分泌肿瘤（NET）患者会出现肝转移，以经动脉栓塞（TAE）为代表的介入治疗是主要的局部治疗方法。索凡替尼被推荐作为晚期 NET 的标准全身治疗。索凡替尼联合TAE治疗肝转移的疗效和安全性尚待确定。本研究旨在比较索凡替尼联合 TAE 与索凡替尼单药治疗肝转移性 NET 的临床结果。方法这是一项前瞻性、多中心、开放标签、随机对照试验。诊断患有肝转移性 NET 的患者将被纳入。参与者按照 1:1 的比例随机分配到实验组或对照组。实验组患者接受索凡替尼联合TAE治疗，对照组患者接受索凡替尼单药治疗。主要终点是由盲法独立影像审查委员会 (BIIRC) 评估的无进展生存期 (PFS)。次要终点是研究者评估的 PFS、肝脏特异性客观缓解率 (ORR)、客观缓解率 (ORR)、疾病控制率 (DCR)、总生存期 (OS) 和不良事件发生率。讨论这是第一个前瞻性研究研究探讨索凡替尼联合 TAE 的疗效。我们期望这项试验能够为肝转移性 NET 提出一种新的有效治疗策略。