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Набор скоро начнётся NCT07191548

International Study on Treatment of Patients With Metastatic Colorectal Liver Lesions Patients With IRE

Без фазы С лечением Colorectal Adenocarcinoma Metastatic in the Liver Liver Ablation Liver Cancer, Adult

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: Irreversible Electroporation.
Кому может быть актуально
Состояния в реестре: Colorectal Adenocarcinoma Metastatic in the Liver, Liver Ablation, Liver Cancer, Adult. 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
Великобритания
Следующий шаг
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Официальное название

Treatment of LIVER METastases From Colorectal Cancer by IRreversible Electroporation: A Prospective, International, Multi-centre Cohort Study.

Обзор

Procedural data will be recorded from patients with liver metastases from colorectal cancer who have received at least one course of systemic chemotherapy and who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation.

Вмешательства

  • Устройство Irreversible Electroporation
    Irreversible electroporation (IRE) is a procedure which involves the passage of short intense electrical pulses between probes to destabilize cell membranes by creating "nanopores" which leads to cell destabilisation and cell death. IRE can be used to selectively damage cancerous cells whilst sparing adjacent supporting connective tissue in vessels and bile ducts allowing a more targeted treatment compared to other types of ablation. IRE also avoids the heat-sink phenomenon which compromises th

Первичные конечные точки

  • Target Tumour Eradication [Срок оценки: 6 months]
Вторичные конечные точки (11)
  • Complications of IRE: Episode-related complications: [Срок оценки: 30 days]
  • Complications of IRE: Intervention for local liver-related complications of IRE [Срок оценки: 12 months]
  • Oncological outcomes: Local progression at site of IRE-treated lesion [Срок оценки: 12 months]
  • Oncological Outcomes: Re-ablation and modality. [Срок оценки: 12 months]
  • Oncological Outcomes: New lesions [Срок оценки: 12 months]
  • Oncological Outcomes: Post IRE Chemotherapy [Срок оценки: 12 months]
  • Oncological Outcomes: Other liver-directed interventions [Срок оценки: 12 months]
  • Oncological Outcomes: Disease-free and overall survival from time of IRE. [Срок оценки: 12 months]
  • Quality of life - pre procedure [Срок оценки: pre procedure up to 7 days]
  • Quality of life - 7 days follow-up [Срок оценки: 7 days]
  • Quality of life - 6 months [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Patients aged 18 years and over, able to provide informed consent and with histological confirmation of a diagnosis of colorectal cancer from primary tumour.
  • Liver lesions demonstrating radiological characteristics (on magnetic resonance scan) of colorectal hepatic metastases without requirement for biopsy. In the setting of an intact liver, patients with up to four metastases ≤ 4cm in size are eligible for inclusion. In the setting of proposed resection plus ablation, up to two metastases ≤ 4cm in size. In the setting of recurrence after prior hepatectomy up to two metastases ≤ 4cm in size.
  • Eastern Co-operative Oncology Group (ECOG) Score ≤ 2.
  • Rockwood Frailty Score ≤ 3.
  • Serum bilirubin < 30 µmol/L.
  • Serum creatinine < 150 µmol/L.
  • Up to two lung metastases (< 2cm in size permitted at enrolment).
  • Prior treatment with at least one course of systemic chemotherapy (± biologic agent) mandated. Chemotherapy protocol is not specified and is at clinician discretion.
  • Primary rectal tumour can remain in situ treated with radiotherapy/chemoradiotherapy according to tumour board recommendations. Primary colonic tumour can remain in situ.
  • No prior hepatic tumour ablation

Критерии исключения

  • Patients involved in other research studies.
  • Inability to give informed consent.
  • Patients who are pregnant.
  • Accepted exclusions to IRE from consensus criteria including:
  • Platelet count < 50x109 U/L.
  • International normalised ratio (INR) for blood clotting > 1.7.
  • Prior hepatic tumour ablation.

Cardiovascular fitness related exclusions:

  • History of ventricular arrhythmia.
  • Implanted pacemaker or defibrillator.
  • Congestive cardiac failure NYHA Class ≥ 3.

Tumour-related exclusions:

  • Tumour ≥ 4 cm in size.
  • Advanced multi-site metastatic cancer (any of the following): peritoneal metastases (M1c), bone metastases, > 2 lung metastases, all segment involvement multiple liver metastases.
  • Jaundice (serum bilirubin > 30 µmol/L).
  • MDT/tumour recommends use of thermal ablation instead of IRE for any given lesion.

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

Великобритания · 1 центр
  • Manchester Royal Infirmiary — Manchester

Идентификаторы

NCT: NCT07191548 · 2025-ONC-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗