Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases (TRASMETIR)

La Fe University and Polytechnic Hospital

Status: Enrolling

Conditions: Liver Metastases; Metastatic Liver Cancer; Colorectal Cancer

Treatments: Procedure: Liver transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT04616495

TRASMETIR

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Liver transplanted patients

Treatment:

Procedure: Liver transplantation