Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
NCT ID: NCT04616495
Last Updated: 2023-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2021-09-01
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Liver transplanted patients
Liver transplantation
Chemotherapy and liver transplantation
Interventions
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Liver transplantation
Chemotherapy and liver transplantation
Eligibility Criteria
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Inclusion Criteria
* Good performance status, ECOG 0 or 1
* Resected adenocarcinoma in colon or rectum (R0 resection)
* Unresectable liver metastases
* No extrahepatic disease
* Normal blood tests
* Response to ≤ 2 lines of chemotherapy (RECIST criteria)
* ≥ 1 year period since diagnosis of colorectal cancer to enrolment in liver transplant waiting list
* Signed informed consent
Exclusion Criteria
* Positive HIV or HCV
* Pregnancy at the time of inclusion
* BRAF mutated status
* Deterioration of general condition (10% weight loss in the prior 6 months)
* Other malignancy with disease free survival \< 5 years
* Concomitant or prior extrahepatic metastases (histologically or radiologically proved), even if surgically resected.
* Palliative resection of primary colorectal adenocarcinoma
* Liver metastases size \> 5 cm (in the last imaging technique)
* CEA \> 80 ng/ml (at time of enrolment in waiting list)
* No neoadjuvant chemotherapy treatment
* General contraindication to liver transplantation
18 Years
65 Years
ALL
No
Sponsors
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Hospital Universitario La Fe
OTHER
Responsible Party
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Eva M. Montalvá
Hepatobiliarypancreatic and Transplant Surgeon
Locations
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Eva M Montalvá
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TRASMETIR
Identifier Type: -
Identifier Source: org_study_id
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