Recruiting

Liver Transplant

Sponsor:

University of Rochester

Code:

NCT05248581

Conditions

Colorectal Cancer Metastatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liver transplantation

Study Details

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

Study ID

NCT05248581

Start date

Aug 16, 2019

Status verified date

Jul, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Liver transplantation

living donor liver transplantation

Primary outcome measure

  • percentage of patients with recurrence free survival [ Time Frame: 5 years ]
  • percentage overall survival [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Roberto Hernandez-Alejandro, MD

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

Jennie Errigo

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

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Roberto Hernandez-Alejandro, MD

roberto_hernandez@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • liver transplantation
  • living donor
  • unresectable colorectal liver metastases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-07-20.