Fecal Microbiota Transplantation (FMT) in Patients With Advanced Gastric 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: Fecal Microbiota Transplantation Capsules, Placebo.
- Кому может быть актуально
- Состояния в реестре: Advanced Gastric 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
- Китай
- 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, Randomised Placebo Controlled Trial of Faecal Microbiota Transplantation in Patients With Advanced Gastric Cancer
Обзор
This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules combined with chemotherapy and anti-PD1/PDL1 therapy in the advanced gastric cancer.
Вмешательства
- Процедура Fecal Microbiota Transplantation Capsules
FMT Capsules in Combination with Chemotherapy and Anti-PD1/PD-L1 Therapy - Процедура Placebo
Mainly composed of starch, the appearance, shape, color, and size are exactly the same as FMT capsules
Первичные конечные точки
- Objective response rate (ORR) [Срок оценки: up to 6 months]
- Rate of Disease Control [Срок оценки: up to 6 months]
Вторичные конечные точки (6)
- Progression-free Survival (PFS) [Срок оценки: up to 2 years]
- Overall Survival (OS) [Срок оценки: up to 2 years]
- Incidence of Adverse Events Related to Treatment [Срок оценки: up to 6 months]
- Change in the intestinal microbiome community [Срок оценки: up to 6 months]
- Quality of life based on the questionnaire [Срок оценки: up to 2 years]
- Change in the immunity [Срок оценки: up to 6 months]
Критерии участия
Критерии включения
Voluntarily participate in this study and provide written informed consent. Age ≥ 18 years , male or female. Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma.
Able and willing to provide tumor tissue. At least one measurable extracranial target lesion according to iRECIST. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Life expectancy ≥3 months.
Критерии исключения
Presence of absolute contra-indications to FMT administration:Toxic megacolon;Inflammatory bowel disease;Anatomic contra-indications to colonoscopy;Colectomy Patient is currently participating and receiving other study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of this study intervention.
Currently under any form of systemic antibiotics. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy two weeks prior to trial treatment. Patients receiving systemic steroids at physiologic doses are permitted to enroll assuming steroid dose is not above the acceptable threshold (> 10 mg prednisone daily or equivalent).
Severe anaphylactic reaction to any food (food allergies). Had a severe hypersensitivity reaction to propofol. Has serious concomitant illnesses. The eligibility can be granted by the treating investigator on individual bases.
Has HIV infection or AIDS-related illness. Has active infection of HAV, HBV or HCV. Patients with a history of Hepatitis B/C infection who have received anti-viral therapy and are disease free may be considered for enrollment after discussion with Principal Investigator.
Patient has received a live vaccine within 4 weeks prior to the first dose of treatment. Seasonal influenza vaccines or COVID-19 vaccines for injection are generally inactivated virus vaccines and are allowed.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Females who are pregnant or breastfeeding. Active central nervous system (CNS) metastases and/or leptomeningeal involvement
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Changhai Hospital — Шанхай
Идентификаторы
NCT: NCT06346093 · CHEC2024-089