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Clinical Trials in Spain / NCT04616495
Recruiting Observational

Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

NCT04616495 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2021-09-01
Last updated
2023-09-22

Condition(s) studied

Colorectal CancerMetastatic Liver CancerLiver Metastases

Investigational drug(s) / intervention(s)

Liver transplantation

Liver transplantation: Chemotherapy and liver transplantation

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Eva M Montalvá Valencia Spain Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04616495 on ClinicalTrials.gov ↗ ← All trials in Spain