Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases

Recruiting

• Conditions: Colorectal Cancer Metastatic
• Interventions: Procedure: Liver transplantation

• Registration Number: NCT05248581
• Lead Sponsor: University of Rochester

Brief Summary

The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.

Detailed Description

The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.

Our primary outcome of interest was the OS and recurrence-free survival (RFS) of patients who underwent LDLT at our center.

Study Timeline

• Study Start: 2019-08-16
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-21
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-24
• Primary Completion: 2027-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Age ≥ 18
• Non-amenable to curative hepatic resection as defined by FLR <30%
• Histologically confirmed adenocarcinoma of the colon or rectum
• Candidate for LDLT for colorectal liver metastasis per the University of Rochester liver transplant program

Exclusion Criteria

• Not a candidate of the LDLT liver transplant protocol for treatment of colorectal liver metastasis.
• Unwilling to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Participants	Liver transplantation	Potential subjects for this registry must have Stage IV colorectal cancer with liver metastases and be candidates for liver transplantation based on multidisciplinary discussion by the Liver transplantation team. Patients must demonstrate favorable tumor biology and no evidence of extra hepatic disease.

Primary Outcome Measures

Name	Time	Method
percentage overall survival	5 years	OS proportions to be calculated at 1, 3, and 5 years with Kaplan Meier analysis
percentage of patients with recurrence free survival	5 years	RFS proportions to be calculated at 1, 3, and 5 years with Kaplan Meier analysis

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States