LT for Unresectable Colorectal Liver Metastasis

NCT04874259 | Recruiting

• 1 other identifier: 209-176-1162
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liver Metastasis Colon Cancer

Keywords

colorectal cancer; liver metastasis; living donor liver transplantation

Outcome Measures

Primary Outcomes (1)

• 1 year patient survival

  1 year patient survival

  1 year

Secondary Outcomes (4)

• 1 year disease-free survival

  1 year

• 3 year patient survival

  3 year

• 3 year disease-free survival

  3 year

• Recurrence

  3 year

Study Arms (1)

Colorectal cancer liver metastasis

EXPERIMENTAL

Liver transplantation for the treatment of unresectable colorectal cancer liver metastasis

Procedure: Living donor liver transplantation

Interventions

Living donor liver transplantation PROCEDURE

Living donor liver transplantation

Colorectal cancer liver metastasis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (12)

• 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.

  PMID: 11775446 BACKGROUND

• 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.

  PMID: 12802483 BACKGROUND

• 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.

  PMID: 16421478 BACKGROUND

• 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.

  PMID: 19470929 BACKGROUND

• 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.

  PMID: 17925551 BACKGROUND

• 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.

  PMID: 23360920 BACKGROUND

• 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.

  PMID: 25297902 BACKGROUND

• 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.

  PMID: 29532908 BACKGROUND

• 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.

  PMID: 30839338 BACKGROUND

• 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.

  PMID: 28544246 BACKGROUND

• 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.

  PMID: 32333096 BACKGROUND

• 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.

  PMID: 31674105 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Nam-Joon Yi, Ph.D.

  Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

YoungRok Choi, MD

CONTACT

82-2072-0069; choiyoungrok@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 5, 2021
• Study Start: August 22, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2026
• Last Updated: September 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)