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

17. juni 2026 oppdatert av: Ting Liu, West China Second University Hospital

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

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

120

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

Inclusion Criteria:

  1. Age greater than 18 years, regardless of sex.
  2. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
  3. 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.
  4. Scheduled to receive neoadjuvant therapy followed by radical surgery.
  5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
  6. No prior systemic anticancer therapy for the current tumor at study baseline.
  7. Willing to participate in the study and able to provide written informed consent.

Exclusion Criteria:

  1. Presence of distant metastasis, peritoneal metastasis, or disease considered no longer suitable for curative-intent treatment.
  2. Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic anticancer therapy for the current tumor.
  3. Severe cognitive impairment, acute psychiatric disorder, or any other condition that prevents the participant from completing study procedures.

  4. Current treatment with antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications, with any of the following occurring within 4 weeks before enrollment:

    1. Increase or decrease in the dose of the relevant medication by 25% or more from the previous maintenance dose;
    2. Initiation, discontinuation, or replacement of antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications;
    3. Adjustment of treatment due to worsening anxiety, depression, insomnia, or other psychiatric or psychological symptoms;
    4. Any medication change or psychological condition judged by the investigator to potentially affect sleep monitoring results or study compliance.
  5. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Poor Objective Sleep Characteristics Group
Participants whose objective sleep characteristics during neoadjuvant immunotherapy are below the predefined median threshold, based on device-estimated deep sleep proportion or a predefined objective sleep composite index. This group is classified as having poor objective sleep characteristics for observational analysis only.
Annen: Ikke relevant - observasjonsstudie
Ikke relevant - observasjonsstudie
Favorable Objective Sleep Characteristics Group
Participants whose objective sleep characteristics during neoadjuvant immunotherapy are at or above the predefined median threshold, based on device-estimated deep sleep proportion or a predefined objective sleep composite index. This group is classified as having favorable objective sleep characteristics for observational analysis only.
Annen: Ikke relevant - observasjonsstudie
Ikke relevant - observasjonsstudie

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Major pathological response (MPR)
Tidsramme: 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.
From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pathological complete response (pCR)
Tidsramme: 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.
From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.
R0 Resection Rate
Tidsramme: 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.
From enrollment to postoperative pathological assessment after radical surgery, approximately 3 to 6 months.
Event-Free Survival (EFS)
Tidsramme: 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.
From enrollment to disease progression, recurrence, death, or last follow-up, assessed up to approximately 36 months.
Recurrence-Free Survival (RFS)
Tidsramme: 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.
From radical surgery to recurrence, death, or last follow-up, assessed up to approximately 36 months.
Overall Survival (OS)
Tidsramme: 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.
From enrollment to death or last follow-up, assessed up to approximately 30 months.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

West China Second University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

26. juni 2026

Primær fullføring (Antatt)

30. juni 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

17. juni 2026

Først innsendt som oppfylte QC-kriteriene

17. juni 2026

Først lagt ut (Faktiske)

23. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • GCNI-SLEEP

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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