Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases

NCT05248581 | Recruiting

• 1 other identifier: STUDY00004076
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Metastatic

Keywords

liver transplantation; living donor; unresectable colorectal liver metastases

Outcome Measures

Primary Outcomes (2)

• percentage of patients with recurrence free survival

  RFS proportions to be calculated at 1, 3, and 5 years with Kaplan Meier analysis

  5 years

• percentage overall survival

  OS proportions to be calculated at 1, 3, and 5 years with Kaplan Meier analysis

  5 years

Study Arms (1)

All Participants

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.

Procedure: Liver transplantation

Interventions

Liver transplantation PROCEDURE

living donor liver transplantation

All Participants

Eligibility Criteria

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

Study Population

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 a tumor board.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

After explant of the native liver, patients will be enrolled in a biorepository with planned collection of snap frozen tissue and plasma and formalin fixed and paraffin embedded samples.

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

• Roberto Hernandez-Alejandro, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Matthew Byrne, MD

  University of Rochester

  STUDY DIRECTOR

Central Study Contacts

Roberto Hernandez-Alejandro, MD

CONTACT

585-275-5875; roberto_hernandez@urmc.rochester.edu

Jennie Errigo

CONTACT

585-275-5875; jennie_errigo@urmc.rochester.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 21, 2022
• Study Start: August 16, 2019
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-06

Locations

US (1)