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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05185245
Other study ID # LITORALE2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date March 30, 2030

Study information

Verified date April 2021
Source IRCCS Azienda Ospedaliero-Universitaria di Bologna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date March 30, 2030
Est. primary completion date March 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 73 Years
Eligibility 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 Design


Intervention

Procedure:
Liver Transplantation
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Locations

Country Name City State
Italy IRCCS Azienda Ospedaliero - Universitaria di Bologna Bologna

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival 5 years
Secondary Disease-Free Survival 5 years
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