An observational study in Colorectal Cancer and Liver Metastasis, sponsored by Pontificia Universidad Catolica de Chile. Recruiting at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Pontificia Universidad Catolica de Chile · Observational
This is an observational study that will follow adults with stage IV colorectal cancer whose disease has spread only to the liver (not to other organs) and who are undergoing a liver transplant as part of their cancer treatment. Liver transplantation is being offered as a potentially curative option for patients whose liver metastases cannot be surgically removed. Researchers will review participants' medical records for up to 5 years after transplant to understand how this treatment affects survival, cancer recurrence, and safety. Participants will also be asked to complete a quality-of-life questionnaire (EORTC QLQ-C30). Taking part in this study does not involve any additional tests, visits, or procedures beyond the standard care participants would otherwise receive.
Liver transplantation has traditionally been used for hepatocellular carcinoma and end-stage liver disease, but international experience over the past three decades has shown that highly selected patients with unresectable colorectal liver metastases and no extrahepatic disease can achieve long-term survival benefit from liver transplantation. Prospective cohorts (SECA-I, SECA-II, RAPID) and a randomized controlled trial (TransMet) have reported 5-year overall survival rates around 50-60% in this population, substantially higher than historical outcomes with chemotherapy alone, particularly when supported by rigorous multidisciplinary patient selection.
Based on this evidence, a liver transplant program for patients with unresectable colorectal liver metastases has been implemented within the UC-CHRISTUS Health Network (Centro del Cáncer, Pontificia Universidad Católica de Chile), building on the institution's liver transplant program of more than 30 years and 500 cases, including living-donor transplantation. Candidates are evaluated by a multidisciplinary hepatobiliary tumor board and, if deemed appropriate, are subsequently reviewed by the institutional liver transplant committee.
This study will describe the clinical course of patients undergoing liver transplantation within this program using data already collected as part of routine clinical care (demographics, pathology, imaging, laboratory results, and surgical and postoperative outcomes), together with a validated quality-of-life questionnaire, with structured follow-up for up to 5 years post-transplant. No additional experimental procedures, biological sampling, or interventions outside standard clinical practice are performed for the purposes of this study. Tumor and serologic biomarkers collected as part of routine care will also be correlated with clinical outcomes.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's planned enrollment of 10 is below the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 222 studies on the registry; 57 are open to participants now.
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Adult patients with histologically confirmed colorectal adenocarcinoma and unresectable liver-only metastatic disease, evaluated and approved for liver transplantation by the multidisciplinary hepatobiliary tumor board and the UC Liver Transplant Committee at the Centro del Cáncer, Red de Salud UC-CHRISTUS. Patients are enrolled consecutively following institutional transplant eligibility criteria. The study reflects the population of a newly implemented liver transplant program for colorectal liver metastases, with approximately 2 patients expected to enter the program per year.
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Exclusion Criteria:
Adults (≥18 years) with stage IV colorectal cancer with liver-only metastases (no extrahepatic disease) who are candidates for liver transplantation as a potentially curative treatment, following evaluation by the institutional multidisciplinary hepatobiliary tumor board and approval by the UC Liver Transplant Committee. Patients receive a liver transplant (living or deceased donor) and are followed with routine clinical and imaging assessments and the EORTC QLQ-C30 quality-of-life questionnaire for up to 5 years post-transplant.
Procedure: Liver transplantation
Total or partial hepatectomy of the recipient's diseased liver followed by orthotopic implantation of a donor liver graft (living donor right or left lobe, or whole graft from a deceased donor), with reconstruction of the portal vein, hepatic artery, hepatic veins, and biliary duct. Performed as a potentially curative treatment for patients with stage IV colorectal cancer whose metastatic disease is confined to the liver and is not amenable to curative resection, following approval by the institutional multidisciplinary hepatobiliary tumor board and the UC Liver Transplant Committee, and after documented response to systemic chemotherapy. Candidates must meet institutional eligibility criteria, including resection of the primary tumor ≥6 months prior, absence of extrahepatic disease, CEA \<80 ng/dL, and absence of BRAF mutation or microsatellite instability.
Overall Survival (OS)
Time from liver transplant to death from any cause, among patients who underwent liver transplantation (as-treated/per-protocol population).
Time frame: Up to 5 years after liver transplantation
Recurrence-Free Survival (RFS), Per-Protocol
Time from liver transplant to first documented radiographic recurrence or death from any cause, whichever occurs first, among patients who underwent liver transplantation (as-treated/per-protocol population).
Time frame: Up to 5 years after liver transplantation
Recurrence-Free Survival (RFS), Intention-to-Treat
Time from liver transplant to first documented radiographic recurrence or death from any cause, whichever occurs first, among patients whose transplant was approved by the UC Liver Transplant Committee (intention-to-treat population).
Time frame: Up to 5 years from committee approval
Overall Survival (OS), Intention-to-Treat
Time from liver transplant to death from any cause, among patients whose transplant was approved by the UC Liver Transplant Committee (intention-to-treat population).
Time frame: Up to 5 years from committee approval
Safety of Liver Transplantation
Incidence and severity of perioperative and postoperative complications, classified according to the Clavien-Dindo classification and CTCAE version 5.0, and coded by preferred term and organ class using the most recent version of MedDRA. Safety of living liver donors is also assessed.
Time frame: At 30 days, 90 days, and 1 year after liver transplantation
Health-Related Quality of Life (EORTC QLQ-C30)
Change in health-related quality of life assessed with the EORTC QLQ-C30, a validated 30-item structured questionnaire designed to evaluate quality of life in cancer patients.
Time frame: At selection, 1 month before transplant, 3 months, 6 months, and at disease progression, up to 5 years
Correlation of Molecular Tumor Markers With Clinical Outcomes
Correlation of molecular marker expression (RAS, BRAF, HER2, and microsatellite instability \[MSI\]), assessed by immunohistochemistry or gene expression by next-generation sequencing (NGS) in primary tumor biopsy and liver explant specimens, with clinical outcomes.
Time frame: Up to 5 years after liver transplantation
Correlation of Serologic and Inflammatory Biomarkers With Clinical Outcomes
Correlation of tumor marker expression (carcinoembryonic antigen \[CEA\]), inflammatory parameters (neutrophil-to-lymphocyte ratio \[NLR\] and lymphocyte counts), C-reactive protein (CRP), and minimal residual disease testing in peripheral blood or plasma with clinical outcomes.
Time frame: Up to 5 years after liver transplantation
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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