- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05185245
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bologna, Italy, 40138
- Recruiting
- IRCCS Azienda Ospedaliero - Universitaria di Bologna
-
Contact:
- Matteo Cescon, M.D.
- Phone Number: +390512144785
- Email: matteo.cescon@unibo.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liver Transplantation
|
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease-Free Survival
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LITORALE2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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