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Идёт набор NCT07319364

A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects

Фаза I С лечением Fecal Microbiota Transplantation (FMT) Gastrointestinal Neoplasms Antineoplastic Agents Drug-related Side Effects and Adverse Reactions

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 (FMT).
Кому может быть актуально
Состояния в реестре: Fecal Microbiota Transplantation (FMT), Gastrointestinal Neoplasms, Antineoplastic Agents, Drug-related Side Effects and Adverse Reactions. 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
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Официальное название

An Observational, Real-World Study Evaluating Fecal Microbiota Transplantation for the Prevention/Reduction of Chemotherapy/Targeted Therapy-Induced Gastrointestinal Symptoms in Patients With Gastrointestinal Cancers.

Обзор

The goal of this clinical trial is to learn if fecal microbiota transplantation can treat in Gastrointestinal cancer patients with chemotherapy / targeted gastrointestinal symptoms. The main question it aims to answer is: To evaluate the effect of fecal microbiota transplantation (FMT) on gastrointestinal tract in patients with gastrointestinal tumors.

Вмешательства

  • Биопрепарат Fecal microbiota transplantation (FMT)
    Building upon the existing treatment regimen, starting from the fourth cycle, one FMT treatment was administered within 3 days prior to chemotherapy/targeted therapy during the fourth, sixth, and eighth cycles (weeks 3, 9, and 15 after study initiation). Each transplant consisted of approximately 40g of donor intestinal bacteria encapsulated in capsules. The capsules were administered orally, typically at a dose of 2-3 capsules (1g/capsule) every 3-5 minutes, totaling 40 capsules per dose for a

Первичные конечные точки

  • Incidence and improvement rate of chemotherapy/targeted therapy-induced gastrointestinal symptoms in patients with gastrointestinal cancers [Срок оценки: At 8 weeks post-FMT]
Вторичные конечные точки (3)
  • The incidence and improvement rate of gastrointestinal (GI) symptoms in patients with gastrointestinal cancers [Срок оценки: At 4 weeks post-FMT]
  • Changes in Gut Microbiota Diversity Indices [Срок оценки: At 4, 8 weeks post-FMT]
  • Correlation Between Changes in Gut Microbiota Abundance and Improvement of Gastrointestinal Symptoms [Срок оценки: At 8 weeks post-FMT]

Критерии участия

Критерии включения

  • Age ≥ 18 years, gender not restricted;
  • Estimated survival time ≥ 3 months;
  • Confirmed diagnosis of gastrointestinal tumors by pathological examination, including esophageal cancer, gastric cancer, colon cancer, rectal cancer, etc.;
  • TNM staging of cancer in patients is Stage IV;
  • Having undergone PD-1 or PD-L1 testing;
  • Planned to receive the 4th cycle of chemotherapy/targeted therapy;
  • Occurrence of gastrointestinal adverse reactions (including but not limited to diarrhea, constipation, vomiting, nausea, etc.) within 3 cycles of conventional chemotherapy/targeted therapy;
  • Patients are able and willing to sign the informed consent form and complete follow-up;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
  • Use of oral/intravenous broad-spectrum antibiotics with caution within 3 days;
  • Patients are able to swallow capsules without chewing;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
  • Laboratory test results during the screening period indicate that the subjects have sufficient organ function.

Критерии исключения

  • Patients with major organ dysfunction or even failure, including but not limited to cardiac insufficiency or heart failure, renal insufficiency or renal failure, and hepatic insufficiency/hepatic failure;
  • Uncontrolled or severe infections;
  • Known history of psychotropic substance abuse, alcoholism, and drug abuse;
  • Patients with severe infections complicated with septicemia or sepsis;
  • Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules;
  • Patients with active viral infections;
  • Female subjects with a positive pregnancy test, lactating female subjects, and women of childbearing age who refuse to use contraceptive measures during the entire observation period (15 weeks);
  • Patients with gastrointestinal perforation and/or fistula;
  • Other conditions deemed unsuitable for enrollment by the investigator.

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
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The Second Affiliated Hospital Zhejiang University School of Medicine — Zhejiang

Идентификаторы

NCT: NCT07319364 · 2025-1390

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗