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LT for Unresectable Colorectal Liver Metastasis

Primary Purpose

Liver Metastasis Colon Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Living donor liver transplantation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Metastasis Colon Cancer focused on measuring colorectal cancer, liver metastasis, living donor liver transplantation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Colorectal cancer liver metastasis

Arm Description

Liver transplantation for the treatment of unresectable colorectal cancer liver metastasis

Outcomes

Primary Outcome Measures

1 year patient survival
1 year patient survival

Secondary Outcome Measures

1 year disease-free survival
1 year disease-free survival
3 year patient survival
3 year patient survival
3 year disease-free survival
3 year disease-free survival
Recurrence
Site and pattern of recurrence

Full Information

First Posted
May 2, 2021
Last Updated
September 1, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04874259
Brief Title
LT for Unresectable Colorectal Liver Metastasis
Official Title
Effectiveness of Liver Transplantation for Unresectable Colorectal Liver Metastasis; Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastasis Colon Cancer
Keywords
colorectal cancer, liver metastasis, living donor liver transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colorectal cancer liver metastasis
Arm Type
Experimental
Arm Description
Liver transplantation for the treatment of unresectable colorectal cancer liver metastasis
Intervention Type
Procedure
Intervention Name(s)
Living donor liver transplantation
Intervention Description
Living donor liver transplantation
Primary Outcome Measure Information:
Title
1 year patient survival
Description
1 year patient survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
1 year disease-free survival
Description
1 year disease-free survival
Time Frame
1 year
Title
3 year patient survival
Description
3 year patient survival
Time Frame
3 year
Title
3 year disease-free survival
Description
3 year disease-free survival
Time Frame
3 year
Title
Recurrence
Description
Site and pattern of recurrence
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YoungRok Choi, MD
Phone
82-2072-0069
Email
choiyoungrok@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Joon Yi, Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YoungRok Choi, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11775446
Citation
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.
Results Reference
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PubMed Identifier
12802483
Citation
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.
Results Reference
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PubMed Identifier
16421478
Citation
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.
Results Reference
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PubMed Identifier
19470929
Citation
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.
Results Reference
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PubMed Identifier
17925551
Citation
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.
Results Reference
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PubMed Identifier
23360920
Citation
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.
Results Reference
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PubMed Identifier
25297902
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
30839338
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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Citation
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Results Reference
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LT for Unresectable Colorectal Liver Metastasis

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