Actively Recruiting
Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
Led by Weill Medical College of Cornell University · Updated on 2025-12-11
20
Participants Needed
1
Research Sites
773 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the colon or rectum
- No evidence of extrahepatic metastases or local recurrence based on PET/CT and colonoscopy
- No signs of extrahepatic metastases or local recurrence according to PET/CT 4 weeks prior to consideration of transplant
- Age 18-65 years old
- Good performance status with ECOG 0-1
- Stability or regression of liver metastasis for at least 6 months
- Minimum of 1 year between diagnosis of colon cancer and liver transplant and 6 months from primary tumor resection and liver transplant
- Minimum of 6 months chemotherapy
- CEA < 200 ug/L 3 months prior to transplant
- 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
You will not qualify if you...
- Evidence of extrahepatic disease or local recurrence
- Previous resection of lung metastases
- MSI-H/dMMR or BRAF mutation
- Any other medical or co-morbid condition that would preclude liver transplantation, as determined by the transplant team
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Weill Cornell Medicine
New York, New York, United States, 10075
Actively Recruiting
Research Team
B
Benjamin M Samstein, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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