Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

NCT ID: NCT05185245

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2030-03-30

Brief Summary

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

Conditions

Liver Metastasis Colon Cancer; Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liver Transplantation

Group Type: EXPERIMENTAL

Liver Transplantation

Intervention Type: PROCEDURE

Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Interventions

Liver Transplantation

Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 73 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Matteo Cescon, M.D.

Role: primary

matteo.cescon@unibo.it

+390512144785

Other Identifiers

LITORALE2020

Identifier Type: -

Identifier Source: org_study_id