Liver transplantation for patients with colorectal cancer that has spread to the liver

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the five-year overall survival rates of patients with unresectable liver-only colorectal metastases who have been well-controlled by chemotherapy prior to undergoing liver transplantation. It involves a multicentric approach where eligible patients will be monitored for their outcomes following the transplantation procedure. The study will focus on patients who meet specific criteria, including having a good performance status and no extrahepatic disease.

Why it matters

Who can join: the full rules

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

Where it's running

• Eva M Montalvá
  Valencia, Spain Recruiting

Study contacts

• Study coordinator: Eva M Montalvá, PhD
• Email: montalva.oron@gmail.com
• Phone: +34961245858

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.