Liver Transplantation for Unresectable Liver Limited Colorectal Metastases

NCT04742621 | Recruiting

• 1 other identifier: 20-04021768
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Interventions

Liver transplant PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. If deemed acceptable candidates for liver transplantation, they will then undergo transplant evaluation as per Weill Cornell Medical College Liver Transplant clinical protocols.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10075, United States

RECRUITING

MeSH Terms

Interventions

Liver Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Benjamin Samstein, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin M Samstein, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 8, 2021
• Study Start: September 30, 2020
• Primary Completion (Estimated): July 27, 2034
• Study Completion (Estimated): July 27, 2035
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)