Liver Transplantation for Unresectable Liver Limited Colorectal Metastases

Recruiting

• Conditions: Unresectable Liver-limited Colorectal Metastases

• Registration Number: NCT04742621
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-30
• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-22
• Primary Completion: 2034-07-27
• Study Completion: 2035-07-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 other medical or co-morbid condition that would preclude liver transplantation, as determined by the transplant team

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	25 years

Secondary Outcome Measures

Name	Time	Method
To determine overall survival (OS) in patients that receive a liver transplant for metastatic colorectal cancer at Weill Cornell Medical College / New York-Presbyterian Hospital	25 years
To determine disease-free survival (DFS) in patients that receive a liver transplant for metastatic colorectal cancer at Weill Cornell Medical College / New York-Presbyterian Hospital	25 years

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States