Objective Sleep Characteristics and Neoadjuvant Immunotherapy Response in Gastric/GEJ Cancer
17 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Estimé)
120
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Qing Li, PhD/MD
- Numéro de téléphone: +8618702848178
- E-mail: liqing@scu.edu.cn
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Sans objet – étude observationnelle
|
|
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.
|
Sans objet – étude observationnelle
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Major pathological response (MPR)
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pathological complete response (pCR)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
26 juin 2026
Achèvement primaire (Estimé)
30 juin 2028
Achèvement de l'étude (Estimé)
31 décembre 2028
Dates d'inscription aux études
Première soumission
17 juin 2026
Première soumission répondant aux critères de contrôle qualité
17 juin 2026
Première publication (Réel)
23 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- GCNI-SLEEP
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .