Liver Transplantation for Unresectable Liver Limited Colorectal Metastases

Description

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.

Conditions

Unresectable Liver-limited Colorectal Metastases

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Study Overview

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Study Details

Study overview

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.

Liver Transplantation for Unresectable Liver Limited Colorectal Metastases

Liver Transplantation for Unresectable Liver Limited Colorectal Metastases

Condition
Unresectable Liver-limited Colorectal Metastases
Intervention / Treatment

-

Contacts and Locations

New York

Weill Cornell Medicine, New York, New York, United States, 10075

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

Benjamin Samstein, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2035-07-27