Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
Weill Medical College of Cornell University
20 participants
Sep 30, 2020
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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 Criteria4
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04742621