Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Study Overview
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Brief Summary
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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: Whole liver graft or partial liver (split) from a deceased donor Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient. Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed. Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy. Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient. 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

Official Title
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Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Conditions
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Liver Metastasis Colon Cancer, Colorectal Cancer

Intervention / Treatment
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* Procedure: Liver Transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 73 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liver Transplantation<br> | Procedure: Liver Transplantation<br>* Liver Transplantation for Non-Resectable Colorectal Liver Metastasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-Free Survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver transplantation, non-resectable colorectal liver metastasis