Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
United States20 participantsStarted 2020-09-30
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Evidence of extrahepatic disease or local recurrence
✕. Previous resection of lung metastases
What they're measuring
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)
Timeframe: 25 years
Trial details
NCT IDNCT04742621
SponsorWeill Medical College of Cornell University