RecruitingNCT04616495
Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
Sponsor
Hospital Universitario La Fe
Enrollment
30 participants
Start Date
Sep 1, 2021
Study Type
OBSERVATIONAL
Conditions
Summary
Multicentric prospective and observational study to assess the 5-year overall survival in a cohort of patients with unresectable liver-only colorectal metastases, well controlled by chemotherapy prior to liver transplantation.
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria9
- ≥ 18 and ≤ years
- 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 Criteria12
- Body mass index ≥ 30
- 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
Interventions
PROCEDURELiver transplantation
Chemotherapy and liver transplantation
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04616495
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