Colorectal Cancer MetastaticNCT05248581
Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases
An observational study of Colorectal Cancer Metastatic, run by University of Rochester at 1 site in United States.
Trial summary
The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Liver transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2019to 1 Aug 2027
- 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: Potential subjects for this registry must have Stage IV colorectal cancer with liver metastases and be candidates for liver transplantation based on multidisciplinary discussion by a tumor board.
Who may be able to join
- Age ≥ 18
- Non-amenable to curative hepatic resection as defined by FLR <30%
- Histologically confirmed adenocarcinoma of the colon or rectum
- Candidate for LDLT for colorectal liver metastasis per the University of Rochester liver transplant program
Who cannot join
- Not a candidate of the LDLT liver transplant protocol for treatment of colorectal liver metastasis.
- Unwilling to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Roberto Hernandez-Alejandro, MD, roberto_hernandez@urmc.rochester.edu
About this study
Official title: Liver Transplantation From Living Donors For Treatment Of Non-Resectable Colorectal Carcinoma Liver Metastases: A Registry Study
The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.
Read the detailed description
The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.
Our primary outcome of interest was the OS and recurrence-free survival (RFS) of patients who underwent LDLT at our center.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Liver transplantation
- Keywords
- liver transplantation, living donor, unresectable colorectal liver metastases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
living donor liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Potential subjects for this registry must have Stage IV colorectal cancer with liver metastases and be candidates for liver transplantation based on multidisciplinary discussion by the Liver transplantation team. Patients must demonstrate favorable tumor biology and no evidence of extra hepatic disease. Receives: Procedure: Liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with recurrence free survival
RFS proportions to be calculated at 1, 3, and 5 years with Kaplan Meier analysis
Measured: 5 years
percentage overall survival
OS proportions to be calculated at 1, 3, and 5 years with Kaplan Meier analysis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start16 Aug 2019
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Hernandez-Alejandro, University of Rochester
- Investigators
- Roberto Hernandez-Alejandro, MD, Principal investigator, University of RochesterMatthew Byrne, MD, Study director, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248581
- Sponsor's protocol ID
- STUDY00004076
- Status last verified
- Jul 2026
- First submitted
- 9 Feb 2022
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation From Living Donors For Treatment Of Non-Resectable Colorectal Carcinoma Liver Metastases: A Registry Study
- ClinicalTrials.gov ID
- NCT05248581
- Acronym / sponsor ID
- STUDY00004076
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- liver transplantation, living donor, unresectable colorectal liver metastases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 16 Aug 2019 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 21 Feb 2022 (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.
The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.
Detailed description
The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.
Our primary outcome of interest was the OS and recurrence-free survival (RFS) of patients who underwent LDLT at our center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Procedure: Liver transplantationPotential subjects for this registry must have Stage IV colorectal cancer with liver metastases and be candidates for liver transplantation based on multidisciplinary discussion by the Liver transplantation team. Patients must demonstrate favorable tumor biology and no evidence of extra hepatic disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential subjects for this registry must have Stage IV colorectal cancer with liver metastases and be candidates for liver transplantation based on multidisciplinary discussion by a tumor board.
Key inclusion criteria (4 listed)
- Age ≥ 18
- Non-amenable to curative hepatic resection as defined by FLR <30%
- Histologically confirmed adenocarcinoma of the colon or rectum
- Candidate for LDLT for colorectal liver metastasis per the University of Rochester liver transplant program
Key exclusion criteria (2 listed)
- Not a candidate of the LDLT liver transplant protocol for treatment of colorectal liver metastasis.
- Unwilling to consent
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 transplantationliving donor liver transplantation | Procedure or surgery | All Participants |
Primary outcome
percentage of patients with recurrence free survival
Time frame: 5 years
RFS proportions to be calculated at 1, 3, and 5 years with Kaplan Meier analysis
percentage overall survival
Time frame: 5 years
OS proportions to be calculated at 1, 3, and 5 years with Kaplan Meier analysis
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 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Roberto Hernandez-Alejandro, MD principal investigator
University of Rochester
Matthew Byrne, MD study director
University of Rochester
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 Metastatic, run by University of Rochester at 1 site in United States.
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 4 inclusion and 2 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 Jul 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 United States. 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 Roberto Hernandez-Alejandro, MD (585-275-5875, roberto_hernandez@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with recurrence free survival (time frame: 5 years). The study lists 2 primary outcomes in all. 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 Jul 2026.