Objective Sleep Characteristics and Neoadjuvant Immunotherapy Response in Gastric/GEJ Cancer
2026년 6월 17일 업데이트: 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.
연구 개요
연구 유형
관찰
등록 (추정된)
120
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Qing Li, PhD/MD
- 전화번호: +8618702848178
- 이메일: liqing@scu.edu.cn
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
해당 없음 - 관찰 연구
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|
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.
|
해당 없음 - 관찰 연구
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Major pathological response (MPR)
기간: 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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pathological complete response (pCR)
기간: 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
기간: 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.
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From enrollment to postoperative pathological assessment after radical surgery, approximately 3 to 6 months.
|
|
Event-Free Survival (EFS)
기간: 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.
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From enrollment to disease progression, recurrence, death, or last follow-up, assessed up to approximately 36 months.
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Recurrence-Free Survival (RFS)
기간: From radical surgery to recurrence, death, or last follow-up, assessed up to approximately 36 months.
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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)
기간: 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.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 26일
기본 완료 (추정된)
2028년 6월 30일
연구 완료 (추정된)
2028년 12월 31일
연구 등록 날짜
최초 제출
2026년 6월 17일
QC 기준을 충족하는 최초 제출
2026년 6월 17일
처음 게시됨 (실제)
2026년 6월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 17일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- GCNI-SLEEP
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
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아니
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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