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Lenvatinib Plus Chemotherapy for pNET Liver Metastases (LEN-pNET)

2026年9月17日 更新者：Peking Union Medical College Hospital

A Study of Second-Line Treatment Response and Resistance Mechanisms in Pancreatic Neuroendocrine Tumors With Liver Metastases Based on cfDNA and Single-Cell PBMC Multi-omics

This prospective, non-randomized, concurrent parallel-controlled study will evaluate treatment response and resistance mechanisms in patients with pancreatic neuroendocrine tumors with liver metastases (pNET-LM) receiving second-line systemic therapy after failure of first-line treatment.

Eligible patients will receive either lenvatinib combined with chemotherapy or chemotherapy alone according to the study protocol and clinical treatment strategy. The clinical efficacy and safety of the two treatment strategies will be evaluated using objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events.

Peripheral blood samples will be collected before treatment, during early treatment, and at disease progression. Circulating cell-free DNA (cfDNA) and peripheral blood mononuclear cells (PBMCs) will be analyzed to investigate molecular and immune changes associated with treatment response, primary resistance, and acquired resistance. The study aims to identify potential biomarkers for predicting treatment response and to improve understanding of resistance mechanisms in pNET-LM.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

80

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100000
        • 招聘中
        • Chinese Academy of Medical Sciences，Peking Union Medical College Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Inclusion Criteria:
  • Age 18 to 75 years.
  • Histologically or cytologically confirmed pancreatic neuroendocrine tumor.
  • Radiologically confirmed liver metastases.
  • Disease progression or treatment failure after first-line systemic therapy, with eligibility for second-line treatment.
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate hematologic, hepatic, and renal function as assessed by the investigator.
  • Life expectancy of at least 12 weeks.
  • Ability to understand and willingness to sign a written informed consent form.

Exclusion Criteria:

  • Poorly differentiated neuroendocrine carcinoma or neuroendocrine tumor originating from a site other than the pancreas.
  • Previous treatment with lenvatinib.
  • Uncontrolled or clinically significant cardiovascular disease, including uncontrolled hypertension.
  • Active severe infection or other uncontrolled serious systemic disease.
  • Known central nervous system metastases that are symptomatic or uncontrolled.
  • Pregnancy or breastfeeding.
  • Participation in another interventional clinical study that may interfere with the outcomes of this study.
  • Any other condition that, in the opinion of the investigator, may make the participant unsuitable for participation in this study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Chemotherapy Alone
药品：Chemotherapy

Chemotherapy will be administered according to the study protocol and clinical characteristics of the participant. The chemotherapy regimen may include an etoposide-platinum regimen or capecitabine plus temozolomide, as specified in the study protocol.
实验性的：Lenvatinib Plus Chemotherapy
药品：Lenvatinib

Lenvatinib will be administered as part of second-line treatment in combination with chemotherapy according to the study protocol.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Objective Response Rate (ORR)
大体时间：From treatment initiation until disease progression, death, or up to 24 months

Objective response rate is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as their best overall response, as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
From treatment initiation until disease progression, death, or up to 24 months

次要结果测量

结果测量
措施说明
大体时间
Progression-Free Survival (PFS)
大体时间：From treatment initiation until disease progression or death, whichever occurs first, assessed up to 24 months

Progression-free survival is defined as the time from treatment initiation to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
From treatment initiation until disease progression or death, whichever occurs first, assessed up to 24 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Peking Union Medical College Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月26日

初级完成 (估计的)

2028年4月1日

研究完成 (估计的)

2028年7月1日

研究注册日期

首次提交

2026年9月17日

首先提交符合 QC 标准的

2026年9月17日

首次发布 (实际的)

2026年9月23日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NET001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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