Objective Sleep Characteristics and Neoadjuvant Immunotherapy Response in Gastric/GEJ Cancer

NCT07662005 | Not Yet Recruiting

• 1 other identifier: GCNI-SLEEP
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Sleep; Pathological Response

Outcome Measures

Primary Outcomes (1)

• Major pathological response (MPR)

  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.

Secondary Outcomes (5)

• Pathological complete response (pCR)

  From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.

• R0 Resection Rate

  From enrollment to postoperative pathological assessment after radical surgery, approximately 3 to 6 months.

• Event-Free Survival (EFS)

  From enrollment to disease progression, recurrence, death, or last follow-up, assessed up to approximately 36 months.

• Recurrence-Free Survival (RFS)

  From radical surgery to recurrence, death, or last follow-up, assessed up to approximately 36 months.

• Overall Survival (OS)

  From enrollment to death or last follow-up, assessed up to approximately 30 months.

Study Arms (2)

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.

Other: Not applicable- observational study

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.

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Not applicable- observational study

Favorable Objective Sleep Characteristics Group; Poor Objective Sleep Characteristics Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Second University Hospital: lead

Central Study Contacts

Qing Li, PhD/MD

CONTACT

+8618702848178; liqing@scu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD/MD

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share