Weill Cornell Medicine
New York, 10075, United States
Location status: Recruiting
Location contact
Benjamin M Samstein, MD
CONTACT
Benjamin Samstein, MD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT04742621
Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
- 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 criteria
- 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
Treatment and study plan
Liver transplant
ProcedureEligibility 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.
Primary outcomes
-
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)
Time frame: 25 years
Secondary outcomes
-
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
Time frame: 25 years
-
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
Time frame: 25 years
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Weill Medical College of Cornell University
Other
Registry information
Important dates
- Study start
- 2020
- Primary completion
- 2034
- Study completion
- 2035
- First posted
- Feb 8, 2021
- Registry last updated
- Dec 11, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.