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Набор скоро начнётся NCT06978062

Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment

Фаза I С лечением GastroEsophageal Cancer

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: Bemarituzumab, FLOT.
Кому может быть актуально
Состояния в реестре: GastroEsophageal Cancer. 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

An Open-label, Multi-centre, Phase 1b Safety and Feasibility Study for the Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment (NeoBEMA)

Обзор

This is an open-label,multi-centre, phase 1b safety and feasibility study aiming to assess the safey and feasibility of bemarituzumab plus chemiotherapy (FLOT) for the peri-operative treatment of resectable gastroesophageal cancer. Following this neo-adjuvant part, patients should undergo surgery. Following surgery, patients will receive FLOT chemotherapy in combination with bemarituzumab. Imaging will be performed every 3 months for the first 2 years and thereafter every 6 months as per standard of care.

Вмешательства

  • Препарат Bemarituzumab
    • Bemarituzumab will be given as a IV infusion
  • Препарат FLOT
    FLOT will be given as a IV infusion

Первичные конечные точки

  • Completion rate of neoadjuvant treatment followed by surgery without serious anastomotic leakage, defined as the percentage of patients who completed the treatment without grade 2 or more anastomotic leakage as per Clavien-Dindo Classification [Срок оценки: 2.3 years from first patient in]
Вторичные конечные точки (9)
  • Major pathological response [Срок оценки: 3.6 years from first patients in]
  • Pathological complete response [Срок оценки: 3.6 years from first patients in]
  • Progression free survival (PFS) [Срок оценки: 3.6 years from first patients in]
  • Overall survival (OS) [Срок оценки: 3.6 years from first patients in]
  • Treatment-emergent adverse events [Срок оценки: 3.6 years from first patients in]
  • R0 resection [Срок оценки: 3.6 years from first patients in]
  • Completion rate of neoadjuvant and adjuvant therapy [Срок оценки: 3.6 years from first patients in]
  • Postoperative complications according to CLAVIEN DINDO classification [Срок оценки: 3.6 years from first patients in]
  • 30 and 90 day-mortality after surgery [Срок оценки: 1.7 years from first patients in]

Критерии участия

Критерии включения

  • Signed screening informed consent
  • Age ≥ 18 years
  • Availability of a diagnostic tumour sample for central evaluation (FFPE block or minimum 10 slides).
  • Histologically proven, previously untreated, locally advanced, resectable gastric/GEJ adenocarcinoma cT2-cT4, N0, M0 or cTany, N+, M0. Note: if the results of the staging laparoscopy are pending at this stage it is acceptable to include the patients in this step, in the interest of patient time-to-treatment.
  • Planned peri-operative treatment with FLOT chemotherapy and surgically assessed feasible R0 resection
  • Centrally confirmed FGFR2b overexpression as defined by ≥10% tumour cells with 2+/3+ FGFR2b staining by immunohistochemistry (IHC)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Previously untreated, locally advanced, histologically confirmed, resectable gastric/GEJ adenocarcinoma cT2-cT4, N0, M0 or cTany, N+, M0 by radiological and surgical staging
  • Adequate hematologic and organ function

Критерии исключения

  • Prior anticancer treatment for the disease under investigation
  • History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmologic corticosteroids
  • Evidence of any ongoing ophthalmologic abnormalities or symptoms that are recent (within 4weeks) or actively progressing
  • Unwillingness to avoid the use of contact lenses during study treatment and follow-up period of at least 100 days after end of treatment.
  • Evidence of, or recent (within 6 months) history of, corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer. Recent (within 6 months) corneal surgery or ophthalmologic laser treatment
  • History of solid organ transplantation
  • History of interstitial lung disease
  • Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study
  • Patients on immunosuppressive therapy or having immune system disorders, including auto-immune diseases. Concurrent steroid use of not more than an equivalent of 10 mg/day prednisolone is allowed. Inhaled, intranasal, intraocular, and/or joint injections of corticosteroids are allowed.

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: NCT06978062 · EORTC 2385-GITCG

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗