Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05185245
• Collaborator: (none)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Liver Metastasis Colon Cancer; Colorectal Cancer	Procedure: Liver Transplantation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
• Actual Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Mar 30, 2025
• Anticipated Study Completion Date: Mar 30, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liver Transplantation	Procedure: Liver Transplantation; Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Outcome Measures

Primary Outcome Measures

1. Overall Survival [5 years]

Secondary Outcome Measures

1. Disease-Free Survival [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 73 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Azienda Ospedaliero - Universitaria di Bologna	Bologna		Italy	40138

Sponsors and Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• ClinicalTrials.gov Identifier: NCT05185245
• Other Study ID Numbers: LITORALE2020
• First Posted: Jan 11, 2022
• Last Update Posted: Jan 11, 2022
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by IRCCS Azienda Ospedaliero-Universitaria di Bologna: liver transplantation; non-resectable colorectal liver metastasis
• Additional relevant MeSH terms: Neoplasm Metastasis; Neoplasms, Second Primary; Liver Neoplasms

Study Results

No Results Posted as of Jan 11, 2022