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NCT Number: NCT07662005

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

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.

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Key information

Conditions

Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Pathological Response Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Not applicable- observational study

Other

Not applicable- observational study

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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.

    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.

  2. R0 Resection Rate

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

    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.

  3. Event-Free Survival (EFS)

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

    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.

  4. Recurrence-Free Survival (RFS)

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

    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.

  5. Overall Survival (OS)

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

    OS is defined as the time from enrollment to death from any cause. Participants who are alive at the time of analysis will be censored at the date of last follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Qing Li, PhD/MD

CONTACT

[email protected]

+8618702848178

Sponsors and collaborators

Lead sponsor

West China Second University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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