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Набор скоро начнётся NCT07662070

Emotional Distress and Pathologic Response in Locally Advanced Gastric/GEJ Adenocarcinoma

— Наблюдательное Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Emotional Distress Pathologic 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, Emotional Distress, Pathologic 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 →

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Официальное название

A Prospective Observational Study of the Association Between Pretreatment Emotional Distress and Pathologic Response to Perioperative Immunotherapy in Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

Обзор

This is a single-center, prospective observational cohort study designed to evaluate the association between pretreatment emotional distress and pathologic response to perioperative immunotherapy in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 120 patients planned for neoadjuvant immunotherapy followed by curative surgery will be enrolled. Emotional distress will be assessed using the PHQ-9 and GAD-7 before treatment initiation and at prespecified time points during treatment. Participants will be classified into an emotional distress group or a non-emotional distress group according to predefined criteria. The primary endpoint is major pathological response (MPR). Secondary endpoints include pathological complete response (pCR), R0 resection rate, event-free survival (EFS), recurrence-free survival (RFS), and overall survival (OS). Exploratory analyses will assess dynamic changes in emotional distress and their associations with peripheral stress markers, peripheral immune markers, and tumor immune microenvironment features.

Вмешательства

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

Первичные конечные точки

  • major pathological response [Срок оценки: Assessed on surgical pathology after completion of neoadjuvant treatment and curative resection, approximately 6 to 12 weeks after treatment initiation]
Вторичные конечные точки (3)
  • Pathological Complete Response (pCR) [Срок оценки: Assessed on surgical pathology at the time of curative resection, approximately 6 to 12 weeks after initiation of perioperative immunotherapy]
  • Event-Free Survival (EFS) [Срок оценки: From enrollment up to 24 months]
  • Overall Survival (OS) [Срок оценки: From enrollment up to 36 months]

Критерии участия

Критерии включения

  • Willing to participate in this study.
  • Age >18 years; both sexes are eligible.
  • Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
  • Resectable locally advanced disease as assessed by imaging and/or multidisciplinary team evaluation, generally corresponding to AJCC 8th edition stage II-III disease, including cT3-4a with any N category or any T with node-positive disease, without distant metastasis.
  • Planned to receive neoadjuvant therapy followed by curative-intent surgery.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • No prior systemic antitumor treatment for the current tumor at baseline.
  • Able to understand and complete questionnaire assessments.
  • Able and willing to provide written informed consent.

Критерии исключения

  • Presence of distant metastasis, peritoneal metastasis, or loss of curative treatment opportunity as determined by clinical evaluation.
  • Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic antitumor treatment for the current tumor.
  • Severe cognitive impairment, acute psychiatric disorder, or any condition that precludes completion of questionnaire assessments.
  • Current treatment with antidepressants, anxiolytics, or other psychotropic medications with any of the following within 4 weeks before baseline assessment: initiation, discontinuation, change in medication type, dose adjustment of 50% or more, or addition of a second or more psychotropic medication.
  • Any other condition judged by the investigator to make the participant unsuitable for enrollment.

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: NCT07662070 · ED-GCGEJ

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗