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Набор скоро начнётся NCT07259473

Factors Influencing Immunotherapy Response in dMMR/MSI-H Gastric/Gastroesophageal Junction Adenocarcinoma

Фаза II С лечением Gastric / Gastroesophageal Junction Adenocarcinoma Mismatch Repair Deficient or MSI-High Solid Tumors Immunotherapy

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: Immunotherapy, Induction chemotherapy, D2 radical gastrectomy.
Кому может быть актуально
Состояния в реестре: Gastric / Gastroesophageal Junction Adenocarcinoma, Mismatch Repair Deficient or MSI-High Solid Tumors, Immunotherapy. Базовые параметры: 18 лет — 85 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

Factors Influencing Immunotherapy Response in Mismatch Repair Deficiency (dMMR) / Microsatellite Instability-High (MSI-H) Gastric/Gastroesophageal Junction Adenocarcinoma

Обзор

dMMR/MSI-H is a key molecular subtype of gastric cancer, found in 8-22% of cases. It is typically associated with older age, female sex, distal tumor location, and intestinal histology (Lauren classification). While this subtype predicts better survival in locally advanced disease, its prognostic role in metastatic settings is less clear. Notably, dMMR/MSI-H tumors are often resistant to conventional chemotherapy. Conversely, they demonstrate exceptional sensitivity to immunotherapy. This has led to effective strategies using immune checkpoint inhibitors, either alone or combined with chemotherapy, in both neoadjuvant and advanced disease settings. However, key challenges remain. Prospective data are largely from Western populations, leaving the efficacy in Asian patients-who bear a high disease burden-less defined. Furthermore, about half of dMMR/MSI-H patients exhibit primary or acquired resistance to immunotherapy. A deeper understanding of the tumor-immune dynamics during treatment is crucial to uncover resistance mechanisms and improve patient outcomes.

Вмешательства

  • Препарат Immunotherapy
    Drug: Immune checkpoint inhibitors (ICIs), specifically PD-1 antibodies, PD-L1 antibodies, PD-1/CTLA-4 bispecific antibodies, or PD-1/CTLA-4 combination therapy. Regimen: 4 treatment cycles.
  • Препарат Induction chemotherapy
    Drug: Oxaliplatin Regimen: 1 cycle Dosage: 130mg/m\^2
  • Процедура D2 radical gastrectomy
    Curative-intent D2 radical gastrectomy is scheduled 4-6 weeks after completion of the fourth cycle.

Первичные конечные точки

  • Rate of pathological complete response [Срок оценки: From the initiation of treatment to the date of surgery, an average of 14 weeks.]
Вторичные конечные точки (5)
  • Major Pathological Response Rate [Срок оценки: From the initiation of treatment to the date of surgery, an average of 14 weeks.]
  • ypN stage [Срок оценки: From the initiation of treatment to the date of surgery, an average of 14 weeks.]
  • R0 resection rate [Срок оценки: From the initiation of treatment to the date of surgery, an average of 14 weeks.]
  • Event-free Survival [Срок оценки: The time from the initiation of treatment until disease progression, disease recurrence, death from any cause, or 3 years since enrollment.]
  • Overall Survival [Срок оценки: From the initiation of treatment until death from any cause or 3 years since enrollment.]

Критерии участия

Критерии включения

  • Male or female, aged 18 to 85 years.
  • Histologically confirmed gastric cancer or adenocarcinoma of the esophagogastric junction (only Siewert types II and III are included).
  • dMMR status confirmed by immunohistochemistry (IHC) or MSI-H status confirmed by PCR/NGS.
  • Tumor clinical staging meeting the following criteria:

cT≥2, any N, M0, assessed by the investigator as potentially resectable and planned for preoperative treatment followed by surgery.

  • Willing to receive treatment with immune checkpoint inhibitors (including, but not limited to, various PD-1 inhibitors, PD-L1 inhibitors, CTLA-4 inhibitors, PD-1/CTLA-4 bispecific antibodies, etc.), which may be combined with or without standard chemotherapy regimens for gastric cancer.

Критерии исключения

  • Tumor histology other than adenocarcinoma, such as squamous cell carcinoma, neuroendocrine carcinoma, etc.
  • Presence of central nervous system metastases and/or leptomeningeal carcinomatosis.
  • Prior antitumor therapy directed at the current gastric cancer (excluding palliative gastrointestinal bypass surgery performed to relieve obstructive symptoms).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07259473 · B2025-541R

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗