Objective Sleep Characteristics and Neoadjuvant Immunotherapy Response in Gastric/GEJ Cancer
2026年6月17日 更新者：Ting Liu、West China Second University Hospital
Objective Sleep Characteristics and Response to Neoadjuvant Immunotherapy in Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A Prospective Observational Study
This prospective observational study will enroll 120 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who are scheduled to receive neoadjuvant immunotherapy followed by radical surgery.
Non-invasive objective sleep monitoring will be performed during the neoadjuvant treatment period to assess sleep characteristics, including sleep duration, sleep efficiency, device-estimated deep sleep proportion, nocturnal awakenings, sleep regularity, heart rate, and heart rate variability.
The primary objective is to evaluate the association between objective sleep characteristics and major pathological response (MPR) after neoadjuvant immunotherapy.
This study will not alter standard treatment decisions, surgical procedures, or perioperative management.
研究概览
研究类型
观察性的
注册 (估计的)
120
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：Qing Li, PhD/MD
- 电话号码：+8618702848178
- 邮箱：liqing@scu.edu.cn
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
取样方法
非概率样本
研究人群
Adult patients with histologically confirmed locally advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who are assessed as resectable by imaging or a multidisciplinary team and are scheduled to receive neoadjuvant immunotherapy followed by radical surgery.
Eligible participants should have stage II-III disease without distant metastasis, an ECOG performance status of 0-1, and no prior systemic anticancer therapy for the current tumor at study baseline.
描述
Inclusion Criteria:
- Age greater than 18 years, regardless of sex.
- Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
- Locally advanced, resectable disease as assessed by imaging or a multidisciplinary team, based on the 8th edition of the AJCC staging system, typically cT3-4a, any N, or any T with N-positive disease, corresponding to stage II-III disease, without distant metastasis.
- Scheduled to receive neoadjuvant therapy followed by radical surgery.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
- No prior systemic anticancer therapy for the current tumor at study baseline.
- Willing to participate in the study and able to provide written informed consent.
Exclusion Criteria:
- Presence of distant metastasis, peritoneal metastasis, or disease considered no longer suitable for curative-intent treatment.
- Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic anticancer therapy for the current tumor.
- Severe cognitive impairment, acute psychiatric disorder, or any other condition that prevents the participant from completing study procedures.
Current treatment with antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications, with any of the following occurring within 4 weeks before enrollment:
- Increase or decrease in the dose of the relevant medication by 25% or more from the previous maintenance dose;
- Initiation, discontinuation, or replacement of antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications;
- Adjustment of treatment due to worsening anxiety, depression, insomnia, or other psychiatric or psychological symptoms;
- Any medication change or psychological condition judged by the investigator to potentially affect sleep monitoring results or study compliance.
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for 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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Poor Objective Sleep Characteristics Group
Participants whose objective sleep characteristics during neoadjuvant immunotherapy are below the predefined median threshold, based on device-estimated deep sleep proportion or a predefined objective sleep composite index.
This group is classified as having poor objective sleep characteristics for observational analysis only.
|
不适用 - 观察性研究
|
|
Favorable Objective Sleep Characteristics Group
Participants whose objective sleep characteristics during neoadjuvant immunotherapy are at or above the predefined median threshold, based on device-estimated deep sleep proportion or a predefined objective sleep composite index.
This group is classified as having favorable objective sleep characteristics for observational analysis only.
|
不适用 - 观察性研究
|
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 |
|---|---|---|
|
Major pathological response (MPR)
大体时间：From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.
|
The proportion of participants who achieve major pathological response after neoadjuvant immunotherapy.
MPR is defined as residual viable tumor cells of 10% or less in the resected tumor specimen after radical surgery.
|
From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pathological complete response (pCR)
大体时间：From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.
|
The proportion of participants who achieve pathological complete response after neoadjuvant immunotherapy.
pCR is defined as the absence of residual viable tumor cells in the resected primary tumor specimen and, if applicable, resected lymph nodes after radical surgery.
|
From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.
|
|
R0 Resection Rate
大体时间：From enrollment to postoperative pathological assessment after radical surgery, approximately 3 to 6 months.
|
The proportion of participants who undergo radical surgery with microscopically margin-negative resection.
R0 resection is defined as no residual tumor at the surgical resection margins based on postoperative pathological assessment.
|
From enrollment to postoperative pathological assessment after radical surgery, approximately 3 to 6 months.
|
|
Event-Free Survival (EFS)
大体时间：From enrollment to disease progression, recurrence, death, or last follow-up, assessed up to approximately 36 months.
|
EFS is defined as the time from enrollment to the first occurrence of any event, including disease progression that precludes radical surgery, local or distant recurrence, or death from any cause, whichever occurs first.
|
From enrollment to disease progression, recurrence, death, or last follow-up, assessed up to approximately 36 months.
|
|
Recurrence-Free Survival (RFS)
大体时间：From radical surgery to recurrence, death, or last follow-up, assessed up to approximately 36 months.
|
RFS is defined as the time from radical surgery to the first documented local or distant recurrence, or death from any cause, whichever occurs first.
Participants without recurrence or death will be censored at the date of last follow-up.
|
From radical surgery to recurrence, death, or last follow-up, assessed up to approximately 36 months.
|
|
Overall Survival (OS)
大体时间：From enrollment to death or last follow-up, assessed up to approximately 30 months.
|
OS is defined as the time from enrollment to death from any cause.
Participants who are alive at the time of analysis will be censored at the date of last follow-up.
|
From enrollment to death or last follow-up, assessed up to approximately 30 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。
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 (估计的)
2026年6月26日
初级完成 (估计的)
2028年6月30日
研究完成 (估计的)
2028年12月31日
研究注册日期
首次提交
2026年6月17日
首先提交符合 QC 标准的
2026年6月17日
首次发布 (实际的)
2026年6月23日
研究记录更新
最后更新发布 (实际的)
2026年6月23日
上次提交的符合 QC 标准的更新
2026年6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
其他研究编号
- GCNI-SLEEP
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.