About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Largest Lesion >5.5cm immediately prior to screening
Patients with Lynch Syndrome
BRAF mutation and/or primary tumor of microsatellite instability (MSI)
Recurrence of primary tumor confirmed by colonoscopy or pelvic MRI within the last 12 months prior to screening.
Trial design
Single group
Treatments tested in this trial
Liver transplantation
Other interventionLiver transplantation
Treatment groups
Trial outcomes
Primary outcomes
Five years overall survival
Percentage of subject who reach the endpoint of overall survival from the inclusion in waiting list until death or last follow-up
Secondary outcomes
One and three years overall survival
Percentage of subjects who reach the endpoint of overall survival from the inclusion in waiting list until death or last follow-up
One, three and five years recurrence free survival
Percentage or patients who did not progress from transplantation until death or last follow-up analysed using Kaplan-Meier and the log-rank test.
Number of patients that drop-out of the study prior to receive intervention
Percentage of patients that drop-out of the study prior to liver transplantation
Patterns of cancer recurrence after liver transplantation
Defined as porcentage of patients with hepatic recurrence, extrahepatic recurrence or both
Other outcomes
Percentage of the intratumoral genetic heterogeneity of the metastatic liver through an in-depth lineage study
High-throughput single-cell RNA sequencing (scRNA-seq) will allow deep phenotyping of cells, allowing detection of rare and common cell populations and determination of developmental trajectories of distinct cell lineages from the metastatic liver removed to the recurrence (hepatic or extrahepatic).
Percentage of patients with circulating tumor DNA (ctDNA)
ctDNA monitorization will be performed pre-chemotherapy, pre-transplantation and every three months after transplantation
Sponsors and contacts
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