Меню
Набор скоро начнётся NCT07662005

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

— Наблюдательное Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Sleep Pathological Response

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Not applicable- observational study.
Кому может быть актуально
Состояния в реестре: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Sleep, Pathological Response. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Вмешательства

  • Другое Not applicable- observational study
    Not applicable- observational study

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07662005 · GCNI-SLEEP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗