NCT07662005Not yet recruiting
Objective Sleep Characteristics and Neoadjuvant Immunotherapy Response in Gastric/GEJ Cancer
Objective Sleep Characteristics and Response to Neoadjuvant Immunotherapy in Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 17 Jun 2026
- Start date
- 26 Jun 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- West China Second University Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07662005
What you commit to
- Study type: Observational
- Planned participants: 120
- From 26 Jun 2026 to the primary completion date, 30 Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic anticancer therapy for the current tumor.
- 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.
Other illness
- Presence of distant metastasis, peritoneal metastasis, or disease considered no longer suitable for curative-intent treatment.
- Severe cognitive impairment, acute psychiatric disorder, or any other condition that prevents the participant from completing study procedures.
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.