Colorectal CancerNCT07884110
Liver Transplantation for Colorectal Cancer
An observational study of Colorectal Cancer and Liver Metastasis, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Liver Metastasis
- What is being tested?
- Liver transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteChile
- Study dates
- 1 Jun 2026to 30 Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Centro del Cáncer UC
Santiago, Santiago Metropolitan
Sebastián P Mondaca, MD, +56991290140, spmondac@uc.cl
About this study
Official title: Liver Transplantation for Colorectal Cancer: a Multicenter Registry
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer, Liver Metastasis
- Being tested
- Liver transplantation
- Keywords
- Liver Transplantation, Colorectal Liver Metastases, Hepatectomy, Living Donor Liver Transplant, Quality of life
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Liver Transplant Recipients | 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. Receives: Procedure: Liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time from liver transplant to death from any cause, among patients who underwent liver transplantation (as-treated/per-protocol population).
Measured: Up to 5 years after liver transplantation
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 5 years after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Jun 2026
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Dr Sotero del Rio
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884110
- Sponsor's protocol ID
- 250905005
- Other IDs
- 250905005
- Status last verified
- Sep 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation for Colorectal Cancer: a Multicenter Registry
- ClinicalTrials.gov ID
- NCT07884110
- Acronym / sponsor ID
- 250905005
- Conditions
- Colorectal Cancer, Liver Metastasis
- Keywords
- Liver Transplantation, Colorectal Liver Metastases, Hepatectomy, Living Donor Liver Transplant, Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Hospital Dr Sotero del Rio
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Transplant Recipients | – | Procedure: Liver transplantationAdults (≥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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver transplantationTotal 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. | Procedure or surgery | Liver Transplant Recipients |
Primary outcome
Overall Survival (OS)
Time frame: Up to 5 years after liver transplantation
Time from liver transplant to death from any cause, among patients who underwent liver transplantation (as-treated/per-protocol population).
7 secondary outcomes
Recurrence-Free Survival (RFS), Per-Protocol
Time frame: Up to 5 years after liver transplantation
Recurrence-Free Survival (RFS), Intention-to-Treat
Time frame: Up to 5 years from committee approval
Overall Survival (OS), Intention-to-Treat
Time frame: Up to 5 years from committee approval
Safety of Liver Transplantation
Time frame: At 30 days, 90 days, and 1 year after liver transplantation
Health-Related Quality of Life (EORTC QLQ-C30)
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
Time frame: Up to 5 years after liver transplantation
Correlation of Serologic and Inflammatory Biomarkers With Clinical Outcomes
Time frame: Up to 5 years after liver transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Liver Metastasis, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastián P Mondaca, MD (+ 56991290140, spmondac@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 5 years after liver transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.