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.

Study Overview

• Status: Recruiting
• Conditions: Unresectable Liver-limited Colorectal Metastases
• Intervention / Treatment: Procedure: Liver transplant

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Benjamin M Samstein, MD; Phone Number: 212-746-2127; Email: samstei@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10075
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Benjamin M Samstein, MD; Phone Number: 212-746-2127; Email: samstei@med.cornell.edu
      • Principal Investigator: Benjamin Samstein, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Benjamin Samstein, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Estimated): July 27, 2034
• Study Completion (Estimated): July 27, 2035

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 20-04021768

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No