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AzTrials

Liver Metastasis Colon CancerNCT04874259

LT for Unresectable Colorectal Liver Metastasis

A study testing Living donor liver transplantation in people with Liver Metastasis Colon Cancer, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Unlike hepatocellular carcinoma, liver transplantation in patients with liver metastasis from colorectal cancer is limited in only few centers. Previously, it was not generally implemented due to lack of organs and high recurrence rates after transplantation. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Liver Metastasis Colon Cancer
What is being tested?
Living donor liver transplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSouth Korea
Study dates
22 Aug 2022to May 2026
Phase
Interventional
Are there results?
None posted in the registry

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Proven colorectal cancer liver metastases without no other treatment (such as immunotherapy, chemotherapy, surgical resection, and radiofrequency ablation)
  • Metastasis isolated to liver
  • Patients selected as a liver transplant recipient at a multidisciplinary meeting
  • Paitents with a willing, healthy living donor
  • Willing and able to provide written informed consent

Who cannot join

  • Pregnant women
  • Known history of human immunodeficiency virus (HIV) infection
  • Patients with active peptic ulcer within 2 weeks of transplantation
  • Persistent colorectal cancer after colon resection
  • Hemodynamically unstable prior to liver transplantation
  • Progression of LM at any timepoint prior to transplant surgery (assessed in a multidisciplinary meeting)

Trial locations and contacts

1 site in 1 country.

YoungRok Choi, MD contact

82-2072-0069

choiyoungrok@gmail.com

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul, 03080

    YoungRok Choi, M.D.

    Recruiting

Other trials in South Korea

About this study

Official title: Effectiveness of Liver Transplantation for Unresectable Colorectal Liver Metastasis; Pilot Study

Unlike hepatocellular carcinoma, liver transplantation in patients with liver metastasis from colorectal cancer is limited in only few centers. Previously, it was not generally implemented due to lack of organs and high recurrence rates after transplantation. However, due to progressive development in treatments, good results such as increased survival rates can be expected even in liver transplant patients with liver metastasis from colorectal cancer, which is known to have poor prognosis. Therefore, the purpose of this study is to analyze the efficacy of liver transplantation as an alternative treatment for liver metastasis from colorectal cancer.

Read the detailed description

Surgical treatment offers a distinct survival benefit in liver metastasis of colorectal cancer (CRC LM). However, it has been estimated that only 40% of patients are candidates for curative liver resection. Liver transplantation can be considered as one of a treatment option, since all evident disease is removed during procedure. However, it is limited in only few centers due to lack of organs and high recurrence rates after transplantation.

Currently, with help of development in treatments, prognosis after LT in CRC LM is improving. Recent study of LT for CRC LM from Norway demonstrated a 5-year survival of 56%. In addition, cohort study and randomized controlled trials are ongoing in Germany and Canada. Therefore, it seems to be necessary to verify the effectiveness of liver transplantation for CRC LM and to verify it as an alternative treatment if there is no other treatment. The purpose of this study is to analyze the efficacy of liver transplantation as an alternative treatment for liver metastasis from colorectal cancer.

Potential participants will be evaluated for liver transplantation and must also have a willing, healthy living donor. Unresectable metastasis should be limited to the liver and stable without no other treatment such as immunotherapy, chemotherapy, surgical resection, and radiofrequency ablation. The suitability of liver transplantation will be evaluated through a multidisciplinary assessment immediately before transplantation. Those participants who undergo liver transplantation will be followed for survival, disease-free survival, and recurrence for 3 years.

Being tested
Living donor liver transplantation
Keywords
colorectal cancer, liver metastasis, living donor liver transplantation
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Living donor liver transplantationProcedure or surgery

    Living donor liver transplantation

Study groups in NCT04874259
Study groupRoleWhat they receive
Colorectal cancer liver metastasisExperimentalLiver transplantation for the treatment of unresectable colorectal cancer liver metastasis
Receives: Procedure: Living donor liver transplantation

What is being measured

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

  1. 1 year patient survival

    1 year patient survival

    Measured: 1 year

Secondary outcomes (4)

  1. 1 year disease-free survival

    1 year disease-free survival

    Measured: 1 year

  2. 3 year patient survival

    3 year patient survival

    Measured: 3 year

  3. 3 year disease-free survival

    3 year disease-free survival

    Measured: 3 year

  4. Recurrence

    Site and pattern of recurrence

    Measured: 3 year

Timeline

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

  1. First posted5 May 2021
  2. Study start22 Aug 2022
  3. Primary completionMay 2023 (estimated)
  4. Study completionMay 2026 (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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04874259
Sponsor's protocol ID
209-176-1162
Status last verified
Sep 2022
First submitted
2 May 2021
Last updated
6 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Koffron A, Fryer JP, Abecassis M. Indications and results of liver transplantation for primary and metastatic liver cancer. Cancer Treat Res. 2001;109:77-99. doi: 10.1007/978-1-4757-3371-6_5. No abstract available.

    PubMed 11775446

  • Honore C, Detry O, De Roover A, Meurisse M, Honore P. Liver transplantation for metastatic colon adenocarcinoma: report of a case with 10 years of follow-up without recurrence. Transpl Int. 2003 Sep;16(9):692-3. doi: 10.1007/s00147-003-0605-3. Epub 2003 Jun 12.

    PubMed 12802483

  • Kappel S, Kandioler D, Steininger R, Langle F, Wrba F, Ploder M, Berlakovich G, Soliman T, Hetz H, Rockenschaub S, Roth E, Muhlbacher F. Genetic detection of lymph node micrometastases: a selection criterion for liver transplantation in patients with liver metastases after colorectal cancer. Transplantation. 2006 Jan 15;81(1):64-70. doi: 10.1097/01.tp.0000189711.98971.9c.

    PubMed 16421478

  • Kopetz S, Chang GJ, Overman MJ, Eng C, Sargent DJ, Larson DW, Grothey A, Vauthey JN, Nagorney DM, McWilliams RR. Improved survival in metastatic colorectal cancer is associated with adoption of hepatic resection and improved chemotherapy. J Clin Oncol. 2009 Aug 1;27(22):3677-83. doi: 10.1200/JCO.2008.20.5278. Epub 2009 May 26.

    PubMed 19470929

  • Tomlinson JS, Jarnagin WR, DeMatteo RP, Fong Y, Kornprat P, Gonen M, Kemeny N, Brennan MF, Blumgart LH, D'Angelica M. Actual 10-year survival after resection of colorectal liver metastases defines cure. J Clin Oncol. 2007 Oct 10;25(29):4575-80. doi: 10.1200/JCO.2007.11.0833.

    PubMed 17925551

  • Hagness M, Foss A, Line PD, Scholz T, Jorgensen PF, Fosby B, Boberg KM, Mathisen O, Gladhaug IP, Egge TS, Solberg S, Hausken J, Dueland S. Liver transplantation for nonresectable liver metastases from colorectal cancer. Ann Surg. 2013 May;257(5):800-6. doi: 10.1097/SLA.0b013e3182823957.

    PubMed 23360920

  • Dueland S, Hagness M, Line PD, Guren TK, Tveit KM, Foss A. Is Liver Transplantation an Option in Colorectal Cancer Patients with Nonresectable Liver Metastases and Progression on All Lines of Standard Chemotherapy? Ann Surg Oncol. 2015 Jul;22(7):2195-200. doi: 10.1245/s10434-014-4137-0. Epub 2014 Oct 9.

    PubMed 25297902

  • Dueland S, Foss A, Solheim JM, Hagness M, Line PD. Survival following liver transplantation for liver-only colorectal metastases compared with hepatocellular carcinoma. Br J Surg. 2018 May;105(6):736-742. doi: 10.1002/bjs.10769. Epub 2018 Mar 13.

    PubMed 29532908

  • Simoneau E, D'Angelica M, Halazun KJ. Liver transplantation for colorectal liver metastasis. Curr Opin Organ Transplant. 2019 Apr;24(2):175-181. doi: 10.1097/MOT.0000000000000623.

    PubMed 30839338

  • 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

  • Glinka J, Ardiles V, Pekolj J, Mattera J, Sanchez Claria R, de Santibanes E, de Santibanes M. Liver transplantation for non-resectable colorectal liver metastasis: where we are and where we are going. Langenbecks Arch Surg. 2020 May;405(3):255-264. doi: 10.1007/s00423-020-01883-2. Epub 2020 Apr 24.

    PubMed 32333096

  • Dueland S, Grut H, Syversveen T, Hagness M, Line PD. Selection criteria related to long-term survival following liver transplantation for colorectal liver metastasis. Am J Transplant. 2020 Feb;20(2):530-537. doi: 10.1111/ajt.15682. Epub 2019 Nov 28.

    PubMed 31674105

Questions about this trial

What is this clinical trial studying?

A study testing Living donor liver transplantation in people with Liver Metastasis Colon Cancer, run by Seoul National University Hospital at 1 site in South Korea.

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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Sep 2022. 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 South Korea. 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?

Results are not available in the source record.

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

Contact YoungRok Choi, MD (82-2072-0069, choiyoungrok@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1 year patient survival (time frame: 1 year). 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 NCT04874259, which also lists 12 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 6 Sep 2022.

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