关键词: NETs TAE clinical trial

来  源:   DOI:10.1177/11795549221127750   PDF(Pubmed)

Abstract:
UNASSIGNED: The number of patients with non-functional neuroendocrine tumors (NETs) has increased recently, and the rate of liver metastasis of NETs is about 20% in patients at the first diagnosis. Transcatheter arterial embolization (TAE) and everolimus are therapies with reported efficacy, but few reports have described their combined treatment. We therefore aim to evaluate the efficacy and safety of combination therapy with everolimus and TAE in patients with liver metastasis of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in a prospective study.
UNASSIGNED: We design a single-arm, open-label, prospective study to evaluate the efficacy and safety of combination therapy with everolimus and TAE in patients with liver metastases of GEP-NETs. The study started in June 2021 at Okayama University Hospital and is expected to enroll 18 patients over a 2-year period.
UNASSIGNED: This study is a prospective study investigating a new treatment method for a rare disease called GEP-NETs. We may obtain useful information that contributes to the treatment guidelines in this study. However, NET is a rare disease, and although the number of cases is statistically established, it may not be possible to accurately assess causality.TRIAL REGISTRATION NUMBER: jRCT1061210015.
摘要:
未经证实:最近非功能性神经内分泌肿瘤(NETs)的患者数量有所增加,初次诊断时,NETs的肝转移率约为20%。经导管动脉栓塞术(TAE)和依维莫司是有报道疗效的疗法,但很少有报道描述他们的联合治疗。因此,我们的目标是在一项前瞻性研究中评估依维莫司和TAE联合治疗对胃肠胰腺神经内分泌肿瘤(GEP-NETs)肝转移患者的疗效和安全性。
UNASSIGNED:我们设计了一个单臂,开放标签,前瞻性研究评估依维莫司和TAE联合治疗GEP-NETs肝转移患者的疗效和安全性。该研究于2021年6月在冈山大学医院开始,预计将在2年内招募18名患者。
UNASSIGNED:这项研究是一项前瞻性研究,旨在研究一种称为GEP-NETs的罕见疾病的新治疗方法。我们可能会获得有助于本研究治疗指南的有用信息。然而,NET是一种罕见的疾病,尽管病例数量是统计确定的,可能无法准确评估因果关系。试用登记号:jRCT1061210015。
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