Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

Recruiting now

Conditions studied: Colorectal Cancer, Metastatic Liver Cancer, Liver Metastases

In brief

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.

Key facts

Study ID

NCT04616495

Run by

Hospital Universitario La Fe

People needed

30

Starts

2021-09-01

Expected to finish

2028-09-01

Last updated by the study team

2023-09-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

• Eva M Montalvá — Valencia, Spain (enrolling)

Full record on ClinicalTrials.gov

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