Menu
Not yet recruiting NCT07662005

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

— Observational Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Sleep Pathological Response

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Not applicable- observational study.
Who it may be relevant to
Registry conditions: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Sleep, Pathological Response. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Objective Sleep Characteristics and Response to Neoadjuvant Immunotherapy in Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A Prospective Observational Study

Overview

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.

Interventions

  • Other Not applicable- observational study
    Not applicable- observational study

Primary outcome measures

  • Major pathological response (MPR) [Time frame: From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.]
Secondary outcome measures (5)
  • Pathological complete response (pCR) [Time frame: From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.]
  • R0 Resection Rate [Time frame: From enrollment to postoperative pathological assessment after radical surgery, approximately 3 to 6 months.]
  • Event-Free Survival (EFS) [Time frame: From enrollment to disease progression, recurrence, death, or last follow-up, assessed up to approximately 36 months.]
  • Recurrence-Free Survival (RFS) [Time frame: From radical surgery to recurrence, death, or last follow-up, assessed up to approximately 36 months.]
  • Overall Survival (OS) [Time frame: From enrollment to death or last follow-up, assessed up to approximately 30 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07662005 · GCNI-SLEEP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗