Liver transplantation for colorectal cancer with liver metastases

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 is an observational study of adults with colorectal cancer that has spread only to the liver and who are undergoing liver transplantation. Researchers will review medical records for up to 5 years after transplant to learn about survival, cancer recurrence, and safety, along with quality-of-life surveys. No extra tests or visits beyond standard care are required. The program builds on established liver transplant experience and uses multidisciplinary selection to describe real-world outcomes in this specific patient group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients aged 18 years or older at the time of evaluation for liver transplantation.
* Both male and female patients are eligible; there are no restrictions based on sex or gender.
* Patients with colorectal cancer (CRC) for whom liver transplantation has been approved as a potential treatment by the institutional liver transplant committee.
* Histologically confirmed adenocarcinoma of the colon or rectum.
* Patient not eligible for curative liver resection.
* Resection of the primary tumor ≥6 months before the planned date of transplantation.
* Standard surgical procedure with adequate resection margins, including a circumferential resection margin (CRM) of ≥2 mm for patients with rectal cancer.
* No signs of local recurrence on colonoscopy.
* Radiological and biomarker (CEA) response to treatment after at least 6 months of systemic therapy. For some higher-risk patients, the multidisciplinary tumor board may require 12 months of response.
* ECOG performance status 0-1.
* No signs or history of extrahepatic metastases on chest/abdomen/pelvis computed tomography (CAP CT) or magnetic resonance imaging (MRI), and on whole-body positron emission tomography/computed tomography (PET/CT).
* Carcinoembryonic antigen (CEA) level below 80 ng/mL at the time of listing for liver transplantation.
* BRAF wild-type and microsatellite stable (MSS).
* Deemed an appropriate transplant candidate by the liver transplant candidate evaluation committee and in accordance with transplant selection criteria.
* A potential living donor available and eligible under Chilean living-donor transplantation law.

Exclusion Criteria:

* Evidence or history of extrahepatic metastases on CT (chest/abdomen/pelvis), MRI, or whole-body PET/CT
* BRAF-mutated tumor
* Microsatellite instability-high (MSI-H) tumor

Where it's running

• Centro del Cáncer UC
  Santiago, Santiago Metropolitan, Chile Recruiting

Study contacts

• Study coordinator: Sebastián P Mondaca, MD
• Email: spmondac@uc.cl
• Phone: + 56991290140

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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.