Overview
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
Eligibility
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