Liver Transplantation for Unresectable Liver Limited Colorectal Metastases

NCT ID: NCT04742621

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2035-07-27

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Samstein, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Benjamin M Samstein, MD

Role: CONTACT

samstei@med.cornell.edu

212-746-2127

Facility Contacts

Benjamin M Samstein, MD

Role: primary

samstei@med.cornell.edu

2127462127

Other Identifiers

20-04021768

Identifier Type: -

Identifier Source: org_study_id