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Liver Transplantation for Unresectable Liver Limited Colorectal Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04742621
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : January 29, 2024
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
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Brief Summary:
This is a single-arm, single institution pilot registry of liver transplantation in patients with unresectable colorectal liver-only metastases at Weill Cornell Medical College. Patients with liver predominant colorectal liver metastases will be screened based on eligibility criteria in a specified clinical hepatobiliary and colorectal liver metastasis tumor board consisting of the principal and co-investigators, representing medical oncology, transplant surgery, radiology, and pathology. The registry aims to track basic demographic data as well as referral patterns, in addition to specific oncologic data such as tumor burden, extent of disease, extent of disease on explant, recurrence rates, patterns of recurrence and survival rates.

Condition or disease Intervention/treatment
Unresectable Liver-limited Colorectal Metastases Procedure: Liver transplant

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
Official Title: Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : July 27, 2034
Estimated Study Completion Date : July 27, 2035

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: Liver transplant
    Eligibility for liver transplantation will be limited to patients with histologically confirmed metastatic colorectal adenocarcinoma who have achieved stability of liver metastasis on chemotherapy for at least 6 months prior to transplantation. All patients who undergo liver transplantation will start immunosuppressive therapy per protocol. Patients who undergo a successful liver transplant will not receive adjuvant therapy.

Outcome Measures
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Primary Outcome Measures :
  1. To develop a registry of liver transplantation in patients with liver limited metastatic colorectal cancer at Weill Cornell Medical College / New York-Presbyterian Hospital (WCMC / NYPH) [ Time Frame: 25 years ]

Secondary Outcome Measures :
  1. To determine disease-free survival (DFS) in patients that receive a liver transplant for metastatic colorectal cancer at Weill Cornell Medical College / New York-Presbyterian Hospital [ Time Frame: 25 years ]
  2. To determine overall survival (OS) in patients that receive a liver transplant for metastatic colorectal cancer at Weill Cornell Medical College / New York-Presbyterian Hospital [ Time Frame: 25 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with liver predominant colorectal liver metastases will be screened based on eligibility criteria in a specified clinical hepatobiliary and colorectal liver metastasis tumor board. If deemed acceptable candidates for liver transplantation, they will then undergo transplant evaluation as per Weill Cornell Medical College Liver Transplant clinical protocols.
Criteria

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the colon or rectum
  2. No evidence of extrahepatic metastases or local recurrence based on PET/CT and colonoscopy
  3. No signs of extrahepatic metastases or local recurrence according to PET/CT 4 weeks prior to consideration of transplant
  4. Age 18-65 years old
  5. Good performance status with ECOG 0-1
  6. Stability or regression of liver metastasis for at least 6 months
  7. Minimum of 1 year between diagnosis of colon cancer and liver transplant and 6 months from primary tumor resection and liver transplant
  8. Minimum of 6 months chemotherapy
  9. CEA < 200 ug/L 3 months prior to transplant
  10. Adequate organ and marrow function with Hb > 10 g/dL, ANC > 1000/uL, platelets > 100,000/uL, bilirubin < 2x ULN, AST/ALT < 5x ULN, Creatinine < 1.25 x ULN, Albumin above LLN

Exclusion Criteria:

  1. Evidence of extrahepatic disease or local recurrence
  2. Previous resection of lung metastases
  3. MSI-H/dMMR or BRAF mutation
  4. Any other medical or co-morbid condition that would preclude liver transplantation, as determined by the transplant team
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04742621


Contacts
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Contact: Benjamin M Samstein, MD 212-746-2127 samstei@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10075
Contact: Benjamin M Samstein, MD    212-746-2127    samstei@med.cornell.edu   
Principal Investigator: Benjamin Samstein, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Benjamin Samstein, MD Weill Medical College of Cornell University
More Information
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04742621    
Other Study ID Numbers: 20-04021768
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: January 29, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes