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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

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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