Recruiting

Liver Transplantation

Sponsor:

Weill Medical College of Cornell University

Code:

NCT04742621

Conditions

Unresectable Liver-limited Colorectal Metastases

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Liver transplant

Study Details

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.

Conditions

Unresectable Liver-limited Colorectal Metastases

Study ID

NCT04742621

Start date

Sep 30, 2020

Status verified date

Dec, 2025

Completion date

Jul 27, 2035

Anticipated

Primary completion date

Jul 27, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Interventions

Liver transplant

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Benjamin M Samstein, MD

212-746-2127samstei@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10075

Contacts

Benjamin M Samstein, MD

2127462127samstei@med.cornell.edu

Principal Investigator:

Benjamin Samstein, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-12-11.