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
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
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
NCT ID
NCT04874259
First Posted
May 2, 2021
Last Updated
September 1, 2022
Sponsor
Seoul National University Hospital
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
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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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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