← Back to Clinical Trials
Recruiting NCT04742621

Liver Transplantation for Unresectable Liver Limited Colorectal Metastases

Trial Parameters

Condition Unresectable Liver-limited Colorectal Metastases
Sponsor Weill Medical College of Cornell University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2020-09-30
Completion 2034-07-27
Interventions
Liver transplant

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 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 Criteria

Inclusion 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 Exclusion Criteria: 1. Evidence of extrahepatic disease or local recurrence 2. Previous resection of lung metastases 3. MSI-H/dMMR or BRAF mutation 4. Any o

Related Trials