Objective Sleep Characteristics and Neoadjuvant Immunotherapy Response in Gastric/GEJ Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWest China Second University Hospital
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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not applicable- observational study
Other interventionNot applicable- observational study
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Poor Objective Sleep Characteristics Group1 intervention
Group B: Favorable Objective Sleep Characteristics Group1 intervention
Trial outcomes
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.
Time frame
From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.Secondary outcomes
1
Pathological complete response (pCR)
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.
Time frame
From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.2
R0 Resection Rate
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.
Time frame
From enrollment to postoperative pathological assessment after radical surgery, approximately 3 to 6 months.3
Event-Free Survival (EFS)
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.
Time frame
From enrollment to disease progression, recurrence, death, or last follow-up, assessed up to approximately 36 months.4
Recurrence-Free Survival (RFS)
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.
Time frame
From radical surgery to recurrence, death, or last follow-up, assessed up to approximately 36 months.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
West China Second University Hospital
Lead sponsor
West China Hospital
Sponsor institution
Source ClinicalTrials.gov
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