Liver Transplantation for Non-resectable Colorectal Liver Metastases: Translational Research

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHospital Vall d'Hebron

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Liver transplantation

    Other intervention

    Liver transplantation

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: TransplantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
5 years

Secondary outcomes

1

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

Time frame
1 and 3 years
2

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.

Time frame
1, 3 and 5 years
3

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

Time frame
Prior to liver transplantation
4

Patterns of cancer recurrence after liver transplantation

Defined as porcentage of patients with hepatic recurrence, extrahepatic recurrence or both

Time frame
5 years

Other outcomes

1

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).

Time frame
On day of transplantation
2

Percentage of patients with circulating tumor DNA (ctDNA)

ctDNA monitorization will be performed pre-chemotherapy, pre-transplantation and every three months after transplantation

Time frame
5 years

Sponsors and contacts

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