A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
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: AZD0901, Rilvegostomig, Trastuzumab Deruxtecan (T-DXd), Capecitabine.
- Кому может быть актуально
- Состояния в реестре: Gastroesophageal Adenocarcinoma. 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
- США, Канада, Китай, Грузия, Италия +6
- 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 Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)
Обзор
GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.
Подробное описание
This Phase II, open-label, multi-drug, multi-center platform study consists of individual sub-studies, each allows the assessment of multiple novel agents or novel combinations.
Participants will be assigned across 3 sub-studies, to have sufficient evaluable participants of the confirmed recommended dose by Safety Review Committee (SRC) for study intervention in each corresponding sub-study.
Вмешательства
- Препарат AZD0901
AZD0901 will be administered as an IV infusion. - Препарат Rilvegostomig
Rilvegostomig will be administered as an IV infusion. - Препарат Trastuzumab Deruxtecan (T-DXd)
T-DXd will be administered as an IV infusion. - Препарат Capecitabine
Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care. - Препарат 5-Fluorouracil (5-FU)
5-FU (Fluoropyrimidine) will be administered as an IV infusion as chemotherapy standard of care. - Препарат FLOT Chemotherapy
FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.
Первичные конечные точки
- Number of participants with adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: Until sub-study completion, up to 38 months]
- Percentage of participants with pathological complete response (pCR) [Срок оценки: Until sub-study completion, up to 38 months]
Вторичные конечные точки (9)
- Surgery completion rate as planned [Срок оценки: Until sub-study completion, up to 38 months]
- R0 resection (complete resection) rate as planned [Срок оценки: Until sub-study completion, up to 38 months]
- Percentage of participants with tumor downstaging [Срок оценки: Until sub-study completion, up to 38 months]
- Event-free survival (EFS) [Срок оценки: Until sub-study completion, up to 38 months]
- Disease-free survival (DFS) [Срок оценки: Until sub-study completion, up to 38 months]
- Objective response rate (ORR) [Срок оценки: Until sub-study completion, up to 38 months]
- Overall survival (OS) [Срок оценки: Until sub-study completion, up to 38 months]
- Serum concentrations of study interventions [Срок оценки: Until sub-study completion, up to 38 months]
- Number of participants with positive anti-drug antibodies (ADA) [Срок оценки: Until sub-study completion, up to 38 months]
Критерии участия
Критерии включения
- Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease
- Participants who are CLDN18.2-positive and HER2-negative in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements for Sub-study 3
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function
- Body weight > 35 kg
Критерии исключения
- Participants had any prior anti-cancer treatment or surgery for the current gastric, GEJ, or esophageal cancer.
- Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment
- Central nervous system (CNS) pathology
- Uncontrolled infections
- Participants with history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis
- History of another primary malignancy
- Participants with any known or suspicious distant metastasis
- Uncontrolled hepatitis B and/or chronic or active hepatitis B
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 12 центров
- Research Site — Пекин
- Research Site — Changchun
- Research Site — Changzhi
- Research Site — Чэнду
- Research Site — Чэнду
- Research Site — Фучжоу
- Research Site — Ханчжоу
- Research Site — Ханчжоу
- … и ещё 4 центра
Япония · 11 центров
- Research Site — Chūōku
- Research Site — Fukuoka
- Research Site — Hidaka-shi
- Research Site — Kashiwa
- Research Site — Kitaadachi-gun
- Research Site — Kōtoku
- Research Site — Nagoya
- Research Site — Osaka
- … и ещё 3 центра
Италия · 9 центров
- Research Site — Florence
- Research Site — Milan
- Research Site — Milan
- Research Site — Milan
- Research Site — Modena
- Research Site — Pisa
- Research Site — Rozzano
- Research Site — Udine
- … и ещё 1 центр
Испания · 9 центров
- Research Site — Barcelona
- Research Site — Barcelona
- Research Site — Elche
- Research Site — Madrid
- Research Site — Málaga
- Research Site — Ourense
- Research Site — Oviedo
- Research Site — Santander
- … и ещё 1 центр
США · 7 центров
- Research Site — Newark
- Research Site — Washington D.C.
- Research Site — Fairway
- Research Site — North Shores
- Research Site — New York
- Research Site — New York
- Research Site — Pittsburgh
Великобритания · 5 центров
- Research Site — Bristol
- Research Site — Dundee
- Research Site — Headington
- Research Site — London
- Research Site — Norwich
Грузия · 4 центра
- Research Site — Tbilisi
- Research Site — Tbilisi
- Research Site — Tbilisi
- Research Site — Tbilisi
Тайвань · 4 центра
- Research Site — Kaohsiung City
- Research Site — Tainan
- Research Site — Taipei
- Research Site — Taoyuan
Turkey (Türkiye) · 4 центра
- Research Site — Adapazarı
- Research Site — Erzurum
- Research Site — Fatih-Istanbul
- Research Site — Istanbul
Канада · 3 центра
- Research Site — Toronto
- Research Site — Montreal
- Research Site — Montreal
Польша · 2 центра
- Research Site — Bialystok
- Research Site — Warsaw
Идентификаторы
NCT: NCT07069712 · D9804C00001 · 2024-516909-23-00