LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis (LIVERMORE)

September 20, 2025 updated by: Fabrizio Di Benedetto, Azienda Ospedaliero-Universitaria di Modena

Living Donor Liver Transplantation (LDLT) in Non Resectable Colo-rectal Cancer Liver Metastasis. The LIVERMORE Trial (LIVing Donor livEr tRansplant Modena cOloRectal mEtastasis) [Original Title in Italian: "Trapianto di Fegato da Donatore Vivente Per Metastasi Epatiche Non Resecabili da Adenocarcinoma Del Colon"]

This study is an interventional open label prospective study that aims to assess both overall and disease-free survival of patients treated with LDLT, partial or whole graft LT from deceased donors for unresectable CRLM.

Secondary outcomes are graft survival and donor outcomes in terms of safety and quality of life.

Donor selection is performed according to the currently used Institutional and National standards and protocols.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Liver Transplant (LT) is a feasible, safe and effective curative strategy for patients with unresectable colorectal liver metastases (CRLM), and several trials are currently active and in a recruitment phase to study its impact with both conventional donors and living donors (LDLT).

As a matter of fact, in this setting living donors represent a helpful resource, thanks to the opportunity to schedule the LT at the timeliest conditions in terms of oncological response and patient's performance status. LDLT is a well-established procedure that is already offered to patients listed for LT at our Institution.

Crucial requirement for study eligibility is the assessment of non-resectability of the presented liver metastases from colorectal cancer (CRC).

Criteria for non-resectability of the liver-only CRC metastases eligible for the study should be assessed at the patient study entry, by the surgeon in charge together with the multidisciplinary team.

Patients fulfilling the inclusion criteria of the study will undergo clinical, translational and regulatory steps. Briefly, the main procedures and requirements of the study can be summarized as follows:

- Pre-transplant screening and waiting phase:

Screening of patients with liver-limited CRC metastases potentially eligible to the study will be registered. The screening for general eligibility to liver transplantation will be conducted according to the existing Institutional protocol (called in Italian "PDTA", "Percorso Diagnostico Terapeutico Assistenziale").

During screening or waiting time periods, patients will continue planned chemotherapy treatment and will undergo blood tests (including CEA and Ca19.9), thoraco-abdominal CT scan and positron emission tomography (PET) scan (if needed) every 8 weeks.

- Donors' screening:

Screening of donors will be held according to the existing Institutional protocol for LDLT

- Informed consent:

Consent to the study will be signed after completion of the pre-LT screening, that is once co-morbidities and transplant eligibility will be ascertained on top of cancer conditions. In addition, patients will have to sign additional written informed consent prior to any study procedure.

- Post-transplant follow-up:

Following LDLT, standard institutional follow-up procedures will be performed and registered. Patient/graft condition and tumor status should be re-assessed at least every 4 months for the first 3 years, every 6 months for the rest of follow-up.

Following donation standard institutional follow up will be performed on donors and registered.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MO
      • Modena, MO, Italy, 41124
        • Recruiting
        • Azienda Ospedaliero Universitaria Di Modena
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fabrizio Di Benedetto, MD PhD FACS
        • Sub-Investigator:
          • Stefano Di Sandro, MD PhD
        • Sub-Investigator:
          • Barbara Catellani, MD
        • Sub-Investigator:
          • Gian Piero Guerrini, MD PhD FACS FEBS
        • Sub-Investigator:
          • Roberto Ballarin, MD PhD
        • Sub-Investigator:
          • Giacomo Assirati, MD
        • Sub-Investigator:
          • Tiziana Olivieri, MD
        • Sub-Investigator:
          • Valentina Serra, MD
        • Sub-Investigator:
          • Paolo Magistri, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18.
  • Histologically confirmed colon and rectum (intraperitoneal) adenocarcinoma.
  • Pathological classification of primary tumor as pT1-3, without peritoneal tumor deposits, absence of mucinous component >50%, confirmed R0 resection, no limitations for RAS mutations, B-RAF wild type.
  • No signs of extra hepatic metastatic disease or local recurrence according to CT scan+MRI+PET/CT scans.
  • Liver metastases not eligible for curative liver resection
  • Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (complete [CR] or partial response [PR] or standard disease [SD]) during second- line treatment for at least 4 months.
  • Carcinoembryonic Antigen (CEA) values stable or decreasing during the enrollment prior to liver transplant.
  • Performance status, ECOG (Eastern Cooperative Oncology Group) 0-2.
  • Signed informed consent and expected cooperation of the patients for the treatment and follow-up, and national/local regulations.

Exclusion Criteria:

  • Hereditary CRC syndromes including FAP (Familial adenomatous polyposis) and Lynch syndrome.
  • Prior extra hepatic metastatic disease or primary tumor local relapse.
  • Palliative resection of primary CRC tumor.
  • Disease progression
  • Other malignancies in the previous 5 years (with exception of in situ cervical carcinoma and basal cell carcinoma; superficial bladder tumors are allowed if curatively treated).
  • Active intra-venous or alcohol abusers (patients may be eligible if abstention > 6 months is demonstrated)
  • Active HIV infection
  • Psychiatric disorders and patient low compliance
  • Any reason why, in the judgment of the investigators, the patient should not participate (to be formally declared)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LDLT, partial graft, whole graft recipients
Patients that undergo LDLT, partial graft or whole graft transplantation for CRLM in the study period
Procedure: Living donor liver transplant, Split liver transplant, RAPID, DDLT
Transplantation of part of the liver from a living donor, or entire cadaveric graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Overall survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only
5 years
Disease free survival
Time Frame: 5 years
Disease-free survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft survival
Time Frame: 5 years
Incidence of retransplant in the LDLT group
5 years
Donor quality of life
Time Frame: 5 years
Measure of Health-related quality of life (HRQOL) of donors using the a Short Form Health Survey 36 (SF-36). SF-36 is a multiplanar scale with scores ranging from 0 to 100 where zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Modena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2032

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 20, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 470/2021/SPER/AOUMO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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