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Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
RECRUITINGSponsored by Hospital Universitario La Fe
Actively Recruiting
SponsorHospital Universitario La Fe
Started2021-09-01
Est. completion2026-09
Eligibility
Age18 Years – 65 Years
View on ClinicalTrials.gov →
NCT04616495
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
Age: 18 Years – 65 Years
Inclusion Criteria: * ≥ 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 Criteria: * 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
Conditions6
CancerColorectal CancerLiver CancerLiver DiseaseLiver MetastasesMetastatic Liver Cancer
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Actively Recruiting
SponsorHospital Universitario La Fe
Started2021-09-01
Est. completion2026-09
Eligibility
Age18 Years – 65 Years
View on ClinicalTrials.gov →
NCT04616495