Меню
Набор скоро начнётся NCT06563947

Single Arm Clinical Trial (Gut Microbiota and HCC)

Фаза II С лечением Liver 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: Oral enterobacterium capsules.
Кому может быть актуально
Состояния в реестре: Liver Cancer. Базовые параметры: 18 лет — 75 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Clinical Study to Evaluate the Effectiveness of Oral Enterobacterial Capsules in Patients With Intermediate and Advanced HCC Who Have Progressed After Immune Checkpoint Inhibitor Combination With Anti-Angiogenesis Targeted Agents

Обзор

To evaluate the efficacy and safety of oral enterobacterial capsules in patients with intermediate and advanced HCC who have progressed after treating with immune checkpoint inhibitors in combination with anti-angiogenesis targeted agents.

Подробное описание

This is a prospective, single-center, single-arm clinical study. For those who meet the enrollment conditions, the original regimen of immune checkpoint inhibitors combined with anti-angiogenic targeted drugs will remain unchanged after enrollment.On this basis, the study subjects started oral enterobacterial capsules to see whther enterobacterial capsules could improve the efficacy of patients receiving the above treatment regimens.

Oral administration of intestinal bacteria capsules 6 capsules/day, after observing no adverse reactions, oral administration for 10 consecutive days, 6 capsules/day from the second day to the tenth day, and then discontinued to the next course of treatment.

Total course of treatment: a total of 4 courses of oral intestinal bacteria capsules, each course of oral administration for 10 days, and a course of 21 days; A course of TKI combined with immune checkpoint inhibitors treatment is 21 days until the disease progresses or intolerable toxicity and side effects appear.

Observe the metrics: Primary Clinical Endpoint - Progression-Free Survival (PFS); Secondary Clinical Endpoints - Overall Growth Phase (OS), Objective Response Rate (ORR), Duration of Response (DOR), and Disease Control Rate (DCR). The new RECIST1.1 criteria were used for the efficacy evaluation system, the CTCAE5.0 grading system was used for the evaluation of common adverse reactions during treatment, and other indicators included imaging including conventional biochemical indexes such as CT and ultrasound, as well as quality of life scores.

Вмешательства

  • Биопрепарат Oral enterobacterium capsules
    Enterobacterium capsules (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days.

Первичные конечные точки

  • Objective Progression-Free Survival (PFS) [Срок оценки: Up to approximately 1 years]
  • Objective Secondary Clinical Endpoints - Overall Growth Phase (OS) [Срок оценки: Up to approximately 1 years]
  • Objective Objective Response Rate (ORR) [Срок оценки: Up to approximately 1 years]
  • ObjectiveDuration of Response (DOR) [Срок оценки: Up to approximately 1 years]
  • Diversity analysis [Срок оценки: Up to approximately 1 years]
  • Species differential analysis [Срок оценки: Up to approximately 1 years]
  • Feces Metabolomics [Срок оценки: Up to approximately 1 years]
  • Serum Metabolomics [Срок оценки: Up to approximately 1 years]

Критерии участия

Критерии включения

  • Age 18-75 years old, gender is not limited;
  • Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium B or C;
  • Clinical diagnosis of HCC progression during TKIs combined with ICIs treatment;
  • Not suitable for local ablation or chemoembolization;
  • Child-Pugh Grade A;
  • ≥ 1 measurable lesion (RECIST v1.1)
  • ECOG PS 0-1

Критерии исключения

  • Usage of antibiotics within 2 weeks prior enrollment;
  • Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)
  • Patients with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
  • Female patients who are pregnant or breastfeeding;
  • Patients with untreated acute or chronic active hepatitis B or hepatitis C infection.
  • Patients are currently undergoing clinical trials of other drugs;
  • Patients are considered by the investigator to be unsuitable for inclusion.

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: NCT06563947 · KY2024-178

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗