NCT05185245

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. 1.Whole liver graft or partial liver (split) from a deceased donor
  2. 2.Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient.
  3. 3.Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed.
  4. 4.Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy.
  5. 5.Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient.
  6. 6.Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
47mo left

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Apr 2021Mar 2030

Study Start

First participant enrolled

April 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2030

Expected
Last Updated

January 11, 2022

Status Verified

April 1, 2021

Enrollment Period

4 years

First QC Date

December 10, 2021

Last Update Submit

January 7, 2022

Conditions

Liver Metastasis Colon CancerColorectal Cancer

Keywords

liver transplantationnon-resectable colorectal liver metastasis

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    5 years

Secondary Outcomes (1)

  • Disease-Free Survival

    5 years

Study Arms (1)

Liver Transplantation

EXPERIMENTAL
Procedure: Liver Transplantation

Interventions

Liver TransplantationPROCEDURE

Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Liver Transplantation

Eligibility Criteria

Age18 Years - 73 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2021

First Posted

January 11, 2022

Study Start

April 1, 2021

Primary Completion

March 30, 2025

Study Completion (Estimated)

March 30, 2030

Last Updated

January 11, 2022

Record last verified: 2021-04

Locations

IT(1)