Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Обзор

The study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival. Patients included in this protocol will be evaluated either for whole or partial liver transplantation from deceased or living donors. Type of different transplantations proposed are as follows: 1. Whole liver graft or partial liver (split) from a deceased donor 2. Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient. 3. Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed. 4. Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy. 5. Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient. 6. Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed. In cases 2-3-5-6 total hepatectomy of native liver can be secondarily performed after having achieved a proper graft hypertrophy in order to avoid a small for size syndrome

Вмешательства

• Процедура Liver Transplantation
  Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Первичные конечные точки

• Overall Survival [Срок оценки: 5 years]

Вторичные конечные точки (1)

• Disease-Free Survival [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Primary tumor resected according to standard oncological practice, p≤T4a, R0 resection
• Colorectal liver metastasis considered as non-resectable either up-front or after previous hepatic resections
• No local recurrence of primary colon cancer confirmed by Positron Emission Tomography, Computed Tomography and colonoscopy
• No extra-hepatic metastatic disease confirmed by Positron Emission Tomography and Computed Tomography
• Good performance status Eastern Cooperative Oncology Group 0 or 1
• Neutrophils > 1.000
• Patients who received at least one line of chemotherapy for at least 3 months with partial response or stable disease according to modified Response Evaluation Criteria in Solid Tumours
• Carcino-Embryonic Antigen < 80 µg/L or reduction of ≥ 50% of highest Carcino-Embryonic Antigen level observed
• Written informed consent
• No other contraindications to liver transplantation

Критерии исключения

• Presence of other malignancies
• Local recurrence of primary tumor
• Extra-hepatic metastatic disease
• Patients who did not receive any neoadjuvant or adjuvant therapy
• Palliative resection of primary tumor
• Any other reason, according to the investigators, that could be a contraindication to protocol enrollment

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

Италия · 1 центр

• IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna

Идентификаторы

NCT: NCT05185245 · LITORALE2020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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