Living Donor Liver Transplantation for CRC Liver Metastases (NCT05175092) | Clinical Trial Compass
WithdrawnNot Applicable
Living Donor Liver Transplantation for CRC Liver Metastases
Stopped: Slow accrual
United States0Started 2023-11
Plain-language summary
This study will test the safety and efficacy of living donor liver transplant after standard-of-care chemotherapy for participants with non-resectable liver metastases (LM) from colorectal cancer. 25 donor-recipient pairs will be enrolled (50 participants). Donors will be on study for 2 years and recipients will be on study for up to 5 years.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Recipient Inclusion Criteria
In order to be eligible to participate in this study, a potential recipient must meet all of the following criteria prior to transplant procedure:
* General inclusion criteria:
* Male or female, aged 18 - 65 years old inclusive, at study entry
* Willing and able to provide written informed consent
* Reside in the United States
* Negative serum pregnancy test for women of childbearing potential
* Cancer-related inclusion criteria:
* Eastern Cooperative Oncology Group (ECOG) : 0 or 1 at all times prior to LDLT
* Biopsy-proven colorectal LM
* Tumor must have the following characteristics
* Non-resectable LM (by consensus of three hepatobiliary (HPB) surgeons). All potential recipients will be presented at Multidisciplinary Tumor Rounds for discussion of treatment options
* Synchronous or Metachronous disease
* R0 resection can be achieved by total hepatectomy
* Primary CRC tumor stage is ≤T3 and ≤N2
* Oslo score of 0-1. The Oslo Score summarizes 4 negative predictive factors for overall survival after liver transplantation for CRLM where each factor is assigned 1 point; maximal diameter of the largest lesion \>5.5 cm, pre-transplant CEA level \>80 μg/L, progressive disease at time of liver transplant and interval from diagnosis to transplant \<2 years
* The patient has undergone first-line "standard of care" chemotherapy for a minimum of 3 months (at the time of screening), with demonstrated stability or reg…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.