Status:
RECRUITING
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Liver Metastasis Colon Cancer
Colorectal Cancer
Eligibility:
All Genders
18-73 years
Phase:
NA
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 wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2030
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05185245
Start Date
April 1 2021
End Date
March 30 2030
Last Update
January 11 2022
Active Locations (1)
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1
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Italy, 40138