预测紫杉醇治疗胃癌的周围神经病变
2026年7月6日 更新者：City of Hope Medical Center
预测胃癌二线化疗中紫杉醇的周围神经病变
尽管化疗的进步改善了胃癌患者的预后，但许多患者仍然遭受不良事件的困扰。
因此，有必要通过识别副作用高风险的患者来建立个性化治疗。
尽管基于紫杉醇的治疗是标准的二线治疗，但周围神经病变是一种麻烦的不良事件。
本研究的目的是建立一种液体活检方法来预测胃癌患者紫杉醇引起的周围神经病变。
研究概览
详细说明
基于紫杉醇的治疗是胃癌患者的标准二线治疗，但约 30-40% 的患者会出现影响日常生活的周围神经病变，约 10% 会出现严重的 3 级周围神经病变。
特别严重的副作用会导致患者失去体力，迫使他们停止治疗，从而失去接受原本有望产生治疗效果的其他治疗的机会。
本研究旨在利用液体活检（小 RNA）预测胃癌患者二线治疗（紫杉醇加雷莫芦单抗）副作用中的周围神经病变。
如果在治疗前可以预测出现副作用的高风险患者，则可以为高风险患者提供药物减量或其他化疗选择。
本研究的目的是通过液体活检预测紫杉醇在胃癌二线化疗中的周围神经病变。
研究类型
观察性的
注册 (估计的)
150
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。
学习联系方式
- 姓名：Ajay Goel, PhD
- 电话号码：6262183452
- 邮箱：AJGOEL@COH.ORG
研究联系人备份
- 姓名：Koichi Takiguchi, PhD
- 电话号码：6262183452
- 邮箱：ktakiguchi@coh.org
学习地点
-
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Okayama-ken
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Kurashiki、Okayama-ken、日本、7010192
- 招聘中
- Kawasaki Medical University
-
接触：
- Takeshi Nagasaka, PhD
- 邮箱：nagasakatahino@gmail.com
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-
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
- 成人
- 年长者
接受健康志愿者
不适用
取样方法
非概率样本
研究人群
无法切除或复发性胃癌的患者需要二线化疗。
描述
纳入标准：
- 组织学证实为原发性胃腺癌的不可切除或复发性胃癌（GC）。
- 年龄超过20岁。
- 东部肿瘤合作组表现状态评分为 0-2。
- 向患者提供完整研究信息后的书面知情同意书。
- 用于晚期 GC 的一线化疗（包括氟化嘧啶和铂类抗癌药物（顺铂或奥沙利铂））的进展或不耐受。
- 使用计算机断层扫描 (CT) 或磁共振成像证实存在可评估的病变。
排除标准：
- 预期寿命短于3个月的患者
- 患有严重并发症（心绞痛、心肌梗塞或心律失常）或无法控制的糖尿病、高血压或出血倾向的患者。
- 有严重过敏反应史或严重药物过敏史的患者。
- 患有临床相关精神障碍且无法回答问卷的患者。
- 主治医师认为不适合参加研究的患者。
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
胃癌二线化疗紫杉醇引起周围神经病变的患者
一组 microRNA，其表达水平是通过逆转录酶定量聚合酶链反应 (RT-qPCR) 检测二线化疗前血液样本中的外泌体 microRNA
|
胃癌二线化疗
其他名称：
|
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胃癌二线化疗紫杉醇无周围神经病变的患者
一组 microRNA，其表达水平是通过逆转录酶定量聚合酶链反应 (RT-qPCR) 检测二线化疗前血液样本中的外泌体 microRNA
|
胃癌二线化疗
其他名称：
|
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 |
|---|---|---|
|
周围神经病变的发生率
大体时间：1年
|
抗癌治疗期间发生的与治疗相关的不良事件的标准方法是不良事件通用术语标准（CTCAE），由美国国家癌症研究所维护。
|
1年
|
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。
调查人员
- 首席研究员：Koichi Takiguchi, PhD、City of Hope Medical Center
出版物和有用的链接
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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)
2018年10月1日
初级完成 (估计的)
2028年6月18日
研究完成 (估计的)
2028年6月18日
研究注册日期
首次提交
2024年6月16日
首先提交符合 QC 标准的
2024年7月3日
首次发布 (实际的)
2024年7月8日
研究记录更新
最后更新发布 (实际的)
2026年7月7日
上次提交的符合 QC 标准的更新
2026年7月6日
最后验证
2026年7月1日
更多信息
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.