About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Increase or decrease in the dose of the relevant medication by 25% or more from the previous maintenance dose;
Trial design
Treatments tested in this trial
- Not applicable- observational study
Treatment groups
Locations
Sponsors and collaborators
West China Second University Hospital
Lead sponsor
West China Hospital
Sponsor institution