Status:
RECRUITING
Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Unresectable Liver-limited Colorectal Metastases
Eligibility:
All Genders
18-65 years
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 pr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 27 2035
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04742621
Start Date
September 30 2020
End Date
July 27 2035
Last Update
December 11 2025
Active Locations (1)
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1
Weill Cornell Medicine
New York, New York, United States, 10075