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.
調査の概要
研究の種類
観察的
入学 (推定)
120
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Qing Li, PhD/MD
- 電話番号：+8618702848178
- メール：liqing@scu.edu.cn
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
該当なし - 観察研究
|
|
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.
|
該当なし - 観察研究
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Major pathological response (MPR)
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pathological complete response (pCR)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月26日
一次修了 (推定)
2028年6月30日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年6月17日
QC基準を満たした最初の提出物
2026年6月17日
最初の投稿 (実際)
2026年6月23日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月23日
QC基準を満たした最後の更新が送信されました
2026年6月17日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- GCNI-SLEEP
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いいえ
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いいえ
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