Studies tumor biology in liver transplant for colorectal cancer that spread to liver
Studies tumor biomarkers in adults with colorectal cancer spread to the liver receiving transplant.
Plain-language title generated from the registry record
Registry title: Liver Transplantation for Non-resectable Colorectal Liver Metastases: Translational Research
Key facts
- Where
- Barcelona, SpainSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colorectal cancer whose liver metastases cannot be removed by surgery, with no cancer spread outside the liver, who may receive a liver transplant.
- Age
- 18 to 70 years
- Sex
- Women and men can join.
- Disease stage
- Colorectal cancer spread to both sides of the liver only, not removable by surgery. Metastases stable or smaller after chemotherapy. No cancer outside the liver on scans. Primary tumor stage T3N1 or lower (T4N0 or T4N2 accepted if 2 or more years since its removal).
- Earlier treatment
- Primary colorectal tumor removed at least 12 months before transplant. At least 3 months of chemotherapy and at most 2 lines of fluoropyrimidine-based chemotherapy, with at least 3 months since the last treatment.
- Biomarker or test result
- CEA of 80 µg/L or lower. BRAF mutation or microsatellite instability (MSI) in the primary tumor is not allowed.
Main reasons for not taking part
- Largest liver lesion bigger than 5.5cm (2.2 in)
- Lynch syndrome
- BRAF mutation and/or MSI in the primary tumor
- Return of the primary tumor in the last 12 months
- Another cancer in the last 5 years (some exceptions)
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT05398380, who can take part
Where in Spain
- Department of HPB Surgery and Transplants, Hospital Vall d´HebronBarcelona, SpainContact: Cristina Dopazo, PhD/MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hospital Vall d'Hebron
- Trial code
- NCT05398380
- Record updated
- 22 May 2026
- Original description
The patients with non-resectable colorectal liver metastases (CRLM) have always being considered a particular subgroup of CRLM in which the therapeutic approach, is focused on strategies that allow a potential surgery like neoadjuvant systemic treatments. But, the underlying biology that causes this particular profile of spread in a proportion of patients that always recur and progress in the liver has not been properly characterized from a biological point of view. Unfortunately, these patients finally develop liver metastasis not amenable for local treatments and become refractory to systemic treatments even without developing extrahepatic liver metastases. As a result, liver transplantation (LT) is a potential for patients without extrahepatic involvement and nonresectable CRLM. There are several studies that aims to evaluate if LT increases overall survival compared to best alternative care. To our knowledge, none of these studies incorporate objectives focused on the underlying tumor biology of this particular population and the development of focused strategies including a dynamic disease monitoring and targeted treatments for this particular population.The METLIVER trial will permit to expand the genetic studies to the whole complexity of metastatic lesions and a more precise evaluation of their genetic heterogeneity. Moreover, it will help to precise the type of genetic analyses on liquid biopsies that can be designed for patients that will unfortunately relapse mostly with lung metastases after LT. Our proposal will maximize the opportunity to produce an unprecedented knowledge on CRLM evolution and will provide new opportunities for relapsed patients.Read full original descriptionShow less
Clinical Impact of Molecular Biomarkers in Liver Transplantation for Non-resectable Colorectal Liver Metastases: Translational Research
The patients with non-resectable colorectal liver metastases (CRLM) have always being considered a particular subgroup of CRLM in which the therapeutic approach, is focused on strategies that allow a potential surgery like neoadjuvant systemic treatments. But, the underlying biology that causes this particular profile of spread in a proportion of patients that always recur and progress in the liver has not been properly characterized from a biological point of view. Unfortunately, these patients finally develop liver metastasis not amenable for local treatments and become refractory to systemic treatments even without developing extrahepatic liver metastases. As a result, liver transplantation (LT) is a potential for patients without extrahepatic involvement and nonresectable CRLM. There are several studies that aims to evaluate if LT increases overall survival compared to best alternative care. To our knowledge, none of these studies incorporate objectives focused on the underlying tumor biology of this particular population and the development of focused strategies including a dynamic disease monitoring and targeted treatments for this particular population.The METLIVER trial will permit to expand the genetic studies to the whole complexity of metastatic lesions and a more precise evaluation of their genetic heterogeneity. Moreover, it will help to precise the type of genetic analyses on liquid biopsies that can be designed for patients that will unfortunately relapse mostly with lung metastases after LT. Our proposal will maximize the opportunity to produce an unprecedented knowledge on CRLM evolution and will provide new opportunities for relapsed patients.
Inclusion: Willing and able to provide written informed consent; Male or female, aged 18-70 years old inclusive at study entry; ECOG (Eastern Cooperative Oncology Group) 0 or 1; Histologically-proven primary colorectal tumor; Bilateral, limited at liver and non-resectable CRLM by consensus in Multidisciplinary Committee; Resection of primary colorectal tumor according oncological principles and adequate TNM stage; Time from primary colorectal tumor resection to transplant ≥ 12 months; Primary colorectal tumor stage ≤ T3N1. If time between primary tumor resection is ≥ 2 years, stage T4N0 or T4N2 is accepted; No signs of extrahepatic metastatic disease according to PET/CT scan, CT and pelvic MRI; 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; 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; CEA (Carcinoembryonic antigen) values ≤ 80 µg/L immediately prior to screening; 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; 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: Largest Lesion >5.5cm immediately prior to screening; Recurrence of primary tumor confirmed by colonoscopy or pelvic MRI within the last 12 months prior to screening; 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; Patients with Lynch Syndrome; Substance abuse, medical, psychological or social conditions that may interfere with the patient´s participation in the study or evaluation of the study results; Cardiac or pulmonary disease uncontrolled as contraindication for any surgical procedure; Active infection; BRAF mutation and/or primary tumor of microsatellite instability (MSI); Pregnant or breast-feeding patients; Any reason why in the opinion of the investigator, the patient should not participate.