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)
20
Enrollment
1
Location
1
Arm
107.9
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1IRCCS Azienda Ospedaliero - Universitaria di BolognaBolognaItaly40138

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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022