Liver Transplantation for Unresectable Liver Limited Colorectal Metastases

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04742621
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 177.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unresectable Liver-limited Colorectal Metastases	Procedure: Liver transplant

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
• Actual Study Start Date: Sep 30, 2020
• Anticipated Primary Completion Date: Jul 27, 2034
• Anticipated Study Completion Date: Jul 27, 2035

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. 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]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical College	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University

Investigators

• Principal Investigator: Karim Halazun, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT04742621
• Other Study ID Numbers: 20-04021768
• First Posted: Feb 8, 2021
• Last Update Posted: Feb 8, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasm Metastasis

Study Results

No Results Posted as of Feb 8, 2021