Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Not Applicable

Recruiting

• Conditions: Colorectal Cancer; Liver Metastasis Colon Cancer
• Interventions: Procedure: Liver Transplantation

• Registration Number: NCT05185245
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-01
• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2022-01-07
• Last Update Submitted: 2022-01-07
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11
• Primary Completion: 2025-03-30
• Study Completion: 2030-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liver Transplantation	Liver Transplantation	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	5 years

Secondary Outcome Measures

Name	Time	Method
Disease-Free Survival	5 years

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna; 🇮🇹 Bologna, Italy