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Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Primary Purpose

Liver Metastasis Colon Cancer, Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Liver Transplantation
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Metastasis Colon Cancer focused on measuring liver transplantation, non-resectable colorectal liver metastasis

Eligibility Criteria

18 Years - 73 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS Azienda Ospedaliero - Universitaria di BolognaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liver Transplantation

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Disease-Free Survival

Full Information

First Posted
December 10, 2021
Last Updated
January 7, 2022
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT05185245
Brief Title
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
Official Title
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
March 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastasis Colon Cancer, Colorectal Cancer
Keywords
liver transplantation, non-resectable colorectal liver metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liver Transplantation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Liver Transplantation
Intervention Description
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Disease-Free Survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
IRCCS Azienda Ospedaliero - Universitaria di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Cescon, M.D.
Phone
+390512144785
Email
matteo.cescon@unibo.it

12. IPD Sharing Statement

Learn more about this trial

Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

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