Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Liver Metastasis Colon Cancer; Colorectal Cancer

Treatments: Procedure: Liver Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05185245

LITORALE2020

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 73 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Liver Transplantation

Experimental group

Treatment:

Procedure: Liver Transplantation