Living Donor Liver Transplant for Unresectable Colorectal... | NCT05248581

Studies
Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases

NCT05248581

Sponsor

University of Rochester

Status

Recruiting

Last Update Posted

Jul 8, 2025Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Colorectal Cancer Metastatic

Interventions

Liver transplantation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 16, 2019Actual

Primary Completion Date

Aug 1, 2027Estimated

Completion Date

Aug 1, 2027Estimated

First Submitted Date

Feb 9, 2022

First Submission Date that Met QC Criteria

Feb 9, 2022

First Posted Date

Feb 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2025

Last Update Posted Date

Jul 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Liver transplantation	Procedure	living donor liver transplantation	All Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roberto Hernandez-Alejandro, MD	Contact	585-275-5875		roberto_hernandez@urmc.rochester.edu
Jennie Errigo	Contact	585-275-5875		jennie_errigo@urmc.rochester.edu

Overall Officials

Name	Affiliation	Role
Roberto Hernandez-Alejandro, MD	University of Rochester	Principal Investigator
Matthew Byrne, MD	University of Rochester	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester Medical Center	Recruiting	Rochester	New York	14642	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016031	Liver Transplantation

Ancestor Terms

ID	Term
D016378	Tissue Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided