Liver transplant study aims to unlock genetic secrets of colorectal cancer spread
NCT ID NCT05398380
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study looks at genetic changes in patients with colorectal cancer that has spread only to the liver and cannot be removed by surgery. Researchers will perform liver transplants and then analyze tumor genetics and blood samples to better understand why the cancer spreads and how to monitor it. The goal is to improve future treatments and outcomes for these patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- liver transplantation
- What this could lead to
- If successful, this research could lead to better ways to monitor and treat colorectal cancer that has spread to the liver, potentially improving survival after liver transplant.
- What could go wrong
- This is a small, early-stage study focused on gathering information, not testing a new treatment. It may not lead to direct benefits for participants, and liver transplant carries serious risks like rejection or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Willing and able to provide written informed consent. 2. Male or female, aged 18-70 years old inclusive at study entry. 3. ECOG (Eastern Cooperative Oncology Group) 0 or 1. 4. Histologically-proven primary colorectal tumor. 5. Bilateral, limited at liver and non-resectable CRLM by consensus in Multidisciplinary Committee. 6. Resection of primary colorectal tumor according oncological principles and adequate TNM stage. 7. Time from primary colorectal tumor resection to transplant ≥ 12 months. 8. Primary colorectal tumor stage ≤ T3N1. If time between primary tumor resection is ≥ 2 years, stage T4N0 or T4N2 is accepted. 9. No signs of extrahepatic metastatic disease according to PET/CT scan, CT and pelvic MRI. 10. The patient has undergone systemic chemotherapy for a minimum of 3 months at the time of screening and maximum of 2 lines of fluoropyrimidine based chemotherapy combined or not with irinotecan or oxaliplatin associated or no not with targeted therapy based in molecular biomarkers. 11. Demonstrated stability or partial regression of CRLM following RECIST criteria v 1.1., at minimum 3 months since the last treatment received and immediately prior to screening. 12. CEA (Carcinoembryonic antigen) values ≤ 80 µg/L immediately prior to screening. 13. Adequate blood test regarding: * Creatinine ≤1.25 x upper normal level or estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m2 using following the Chronic Kidney disease epidemiology collaboration (CKD-EPI) formula. * Platelets ≥80 × 109/L * Neutrophiles ≥ 2.5 × 109/L 14. Patients with hepatic failure after resection will be considered if it occurs as a consequence of an inadequate preoperative estimation of the functional volume that would have contraindicated the surgery. They should meet the inclusion criteria and none of the exclusion criteria. Exclusion Criteria: 1. Largest Lesion \>5.5cm immediately prior to screening 2. Patients with Lynch Syndrome 3. BRAF mutation and/or primary tumor of microsatellite instability (MSI) 4. Recurrence of primary tumor confirmed by colonoscopy or pelvic MRI within the last 12 months prior to screening. 5. Previous or concurrent cancer in the last 5 years. Any cancer curatively treated 5 years prior to entry or treated basal cell carcinoma is permitted. 6. Substance abuse, medical, psychological or social conditions that may interfere with the patient´s participation in the study or evaluation of the study results. 7. Cardiac or pulmonary disease uncontrolled as contraindication for any surgical procedure. 8. Active infection. 9. Pregnant or breast-feeding patients 10. Any reason why in the opinion of the investigator, the patient should not participate.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of HPB Surgery and Transplants, Hospital Vall d´Hebron
RECRUITINGBarcelona, Barcelona, 08035, Spain
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