AzTrials
AzTrials

Colon AdenocarcinomaLIVERMORENCT05186116

LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis

A study testing Living donor liver transplant, Split liver transplant, RAPID, DDLT in people with Colon Adenocarcinoma and Liver Metastasis Colon Cancer, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 77 years
What is being tested?
Living donor liver transplant, Split liver transplant, RAPID, DDLT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteItaly
Study dates
1 Jan 2022to 1 Jan 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 77 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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)
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting
  • Azienda Ospedaliero Universitaria di Modena

    Modena, MO, 41124

    Fabrizio Di Benedetto, MD PhD FACS, +390594225178, fabrizio.dibenedetto@unimore.it

    Paolo Magistri, MD, +390594225178, paolo.magistri@unimore.it

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Living donor liver transplant, Split liver transplant, RAPID, DDLT
Keywords
LDLT, living donor, CRLM, transplant oncology
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Living donor liver transplant, Split liver transplant, RAPID, DDLTProcedure or surgery

    Transplantation of part of the liver from a living donor, or entire cadaveric graft

Study groups in NCT05186116
Study groupRoleWhat they receive
LDLT, partial graft, whole graft recipientsExperimentalPatients that undergo LDLT, partial graft or whole graft transplantation for CRLM in the study period
Receives: Procedure: Living donor liver transplant, Split liver transplant, RAPID, DDLT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Overall survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only

    Measured: 5 years

  2. Disease free survival

    Disease-free survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only

    Measured: 5 years

Secondary outcomes (2)
  1. Graft survival

    Incidence of retransplant in the LDLT group

    Measured: 5 years

  2. Donor quality of life

    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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start1 Jan 2022
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05186116
Sponsor's protocol ID
470/2021/SPER/AOUMO
Acronym
LIVERMORE
Status last verified
Sep 2025
First submitted
24 Nov 2021
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014 Jun 1;74(11):2913-21. doi: 10.1158/0008-5472.CAN-14-0155.

    PubMed 24840647
  • Fong Y, Fortner J, Sun RL, Brennan MF, Blumgart LH. Clinical score for predicting recurrence after hepatic resection for metastatic colorectal cancer: analysis of 1001 consecutive cases. Ann Surg. 1999 Sep;230(3):309-18; discussion 318-21. doi: 10.1097/00000658-199909000-00004.

    PubMed 10493478
  • Abdalla EK, Hicks ME, Vauthey JN. Portal vein embolization: rationale, technique and future prospects. Br J Surg. 2001 Feb;88(2):165-75. doi: 10.1046/j.1365-2168.2001.01658.x.

    PubMed 11167863
  • Cremolini C, Casagrande M, Loupakis F, Aprile G, Bergamo F, Masi G, Moretto R R, Pietrantonio F, Marmorino F, Zucchelli G, Tomasello G, Tonini G, Allegrini G, Granetto C, Ferrari L, Urbani L, Cillo U, Pilati P, Sensi E, Pellegrinelli A, Milione M, Fontanini G, Falcone A. Efficacy of FOLFOXIRI plus bevacizumab in liver-limited metastatic colorectal cancer: A pooled analysis of clinical studies by Gruppo Oncologico del Nord Ovest. Eur J Cancer. 2017 Mar;73:74-84. doi: 10.1016/j.ejca.2016.10.028. Epub 2016 Dec 13.

    PubMed 27986363
  • Lang H, de Santibanes E, Schlitt HJ, Malago M, van Gulik T, Machado MA, Jovine E, Heinrich S, Ettorre GM, Chan A, Hernandez-Alejandro R, Robles Campos R, Sandstrom P, Linecker M, Clavien PA. 10th Anniversary of ALPPS-Lessons Learned and quo Vadis. Ann Surg. 2019 Jan;269(1):114-119. doi: 10.1097/SLA.0000000000002797.

    PubMed 29727331
  • Wicherts DA, de Haas RJ, Salloum C, Andreani P, Pascal G, Sotirov D, Adam R, Castaing D, Azoulay D. Repeat hepatectomy for recurrent colorectal metastases. Br J Surg. 2013 May;100(6):808-18. doi: 10.1002/bjs.9088. Epub 2013 Mar 12.

    PubMed 23494765
  • Butte JM, Gonen M, Allen PJ, Peter Kingham T, Sofocleous CT, DeMatteo RP, Fong Y, Kemeny NE, Jarnagin WR, D'Angelica MI. Recurrence After Partial Hepatectomy for Metastatic Colorectal Cancer: Potentially Curative Role of Salvage Repeat Resection. Ann Surg Oncol. 2015 Aug;22(8):2761-71. doi: 10.1245/s10434-015-4370-1. Epub 2015 Jan 9.

    PubMed 25572686
  • Kanas GP, Taylor A, Primrose JN, Langeberg WJ, Kelsh MA, Mowat FS, Alexander DD, Choti MA, Poston G. Survival after liver resection in metastatic colorectal cancer: review and meta-analysis of prognostic factors. Clin Epidemiol. 2012;4:283-301. doi: 10.2147/CLEP.S34285. Epub 2012 Nov 7.

    PubMed 23152705
  • Pawlik TM, Schulick RD, Choti MA. Expanding criteria for resectability of colorectal liver metastases. Oncologist. 2008 Jan;13(1):51-64. doi: 10.1634/theoncologist.2007-0142.

    PubMed 18245012
  • Tsai MS, Su YH, Ho MC, Liang JT, Chen TP, Lai HS, Lee PH. Clinicopathological features and prognosis in resectable synchronous and metachronous colorectal liver metastasis. Ann Surg Oncol. 2007 Feb;14(2):786-94. doi: 10.1245/s10434-006-9215-5. Epub 2006 Nov 14.

    PubMed 17103254
  • Hill CR, Chagpar RB, Callender GG, Brown RE, Gilbert JE, Martin RC 2nd, McMasters KM, Scoggins CR. recurrence following hepatectomy for metastatic colorectal cancer: development of a model that predicts patterns of recurrence and survival. Ann Surg Oncol. 2012 Jan;19(1):139-44. doi: 10.1245/s10434-011-1921-y. Epub 2011 Jul 13.

    PubMed 21751045
  • Muhlbacher F, Huk I, Steininger R, Gnant M, Gotzinger P, Wamser P, Banhegyi C, Piza F. Is orthotopic liver transplantation a feasible treatment for secondary cancer of the liver? Transplant Proc. 1991 Feb;23(1 Pt 2):1567-8. No abstract available.

    PubMed 1989293
  • Toso C, Pinto Marques H, Andres A, Castro Sousa F, Adam R, Kalil A, Clavien PA, Furtado E, Barroso E, Bismuth H; Compagnons Hepato-Biliaires Group. Liver transplantation for colorectal liver metastasis: Survival without recurrence can be achieved. Liver Transpl. 2017 Aug;23(8):1073-1076. doi: 10.1002/lt.24791. No abstract available.

    PubMed 28544246
  • Grut H, Dueland S, Line PD, Revheim ME. The prognostic value of 18F-FDG PET/CT prior to liver transplantation for nonresectable colorectal liver metastases. Eur J Nucl Med Mol Imaging. 2018 Feb;45(2):218-225. doi: 10.1007/s00259-017-3843-9. Epub 2017 Oct 12.

    PubMed 29026950
  • D'Angelica M, Kornprat P, Gonen M, DeMatteo RP, Fong Y, Blumgart LH, Jarnagin WR. Effect on outcome of recurrence patterns after hepatectomy for colorectal metastases. Ann Surg Oncol. 2011 Apr;18(4):1096-103. doi: 10.1245/s10434-010-1409-1. Epub 2010 Nov 2.

    PubMed 21042942

Questions about this trial

What is this clinical trial studying?

A study testing Living donor liver transplant, Split liver transplant, RAPID, DDLT in people with Colon Adenocarcinoma and Liver Metastasis Colon Cancer, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05186116, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in