Living Donor Liver Transplantation for CRC Liver Metastases

NCT05175092 | Withdrawn DMC

• 4 other identifiers: 2021-0021A539742Protocol Version 7/15/2022UW20113
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the safety and efficacy of living donor liver transplant after standard-of-care chemotherapy for participants with non-resectable liver metastases (LM) from colorectal cancer. 25 donor-recipient pairs will be enrolled (50 participants). Donors will be on study for 2 years and recipients will be on study for up to 5 years.

Conditions

Liver Metastasis Colon Cancer

Keywords

living donor liver transplant

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival, defined as length of time from the start of (neoadjuvant) chemotherapy that subjects diagnosed with colorectal liver metastases are still alive.

  participants followed up to 5 years

Secondary Outcomes (6)

• Disease Free Survival (DFS)

  up to 5 years

• Site of Recurrence (Organs Affected)

  up to 5 years

• Number of Sites of Recurrence per Participant

  up to 5 years

• Survival Rate

  up to 5 years

• Quality of Life Survey Score: EORTC QLQ-C30

  up to 5 years

Study Arms (2)

Intent to Treat: LDLT

EXPERIMENTAL

Living Donor Liver Transplantation

Procedure: Living Donor Liver Transplantation

Control Group

NO INTERVENTION

Enrolled but does not receive LDLT

Interventions

Living Donor Liver Transplantation PROCEDURE

The LDLT will be performed by the UW Division of Transplantation in accordance with the standard of care for this operation.

Also known as: LDLT

Intent to Treat: LDLT

Eligibility Criteria

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

You may qualify if:

• In order to be eligible to participate in this study, a potential recipient must meet all of the following criteria prior to transplant procedure:
• Male or female, aged 18 - 65 years old inclusive, at study entry
• Willing and able to provide written informed consent
• Reside in the United States
• Negative serum pregnancy test for women of childbearing potential
• Eastern Cooperative Oncology Group (ECOG) : 0 or 1 at all times prior to LDLT
• Biopsy-proven colorectal LM
• Tumor must have the following characteristics
• Non-resectable LM (by consensus of three hepatobiliary (HPB) surgeons). All potential recipients will be presented at Multidisciplinary Tumor Rounds for discussion of treatment options
• Synchronous or Metachronous disease
• R0 resection can be achieved by total hepatectomy
• Primary CRC tumor stage is ≤T3 and ≤N2
• Oslo score of 0-1. The Oslo Score summarizes 4 negative predictive factors for overall survival after liver transplantation for CRLM where each factor is assigned 1 point; maximal diameter of the largest lesion \>5.5 cm, pre-transplant CEA level \>80 μg/L, progressive disease at time of liver transplant and interval from diagnosis to transplant \<2 years
• The patient has undergone first-line "standard of care" chemotherapy for a minimum of 3 months (at the time of screening), with demonstrated stability or regression of LM based on RECIST v 1.1 criteria
• The only site of metastases is the liver (Staging CT scans are clear of metastases)

You may not qualify if:

• A potential recipient who meets any of the following criteria will be excluded from participation in this study:
• Substance abuse, medical, psychological or social conditions that may interfere with the potential recipient's participation in the study or evaluation of the study results
• Known or suspected allergy to any agent given in association with this trial
• Any condition that is unstable or which could jeopardize the safety of the potential recipient and his/her compliance in the study
• Pregnant or breast-feeding patients
• Previous or concurrent cancer that is distinct in primary site or histology from adenocarcinoma, except ductal carcinoma in situ, cervical carcinoma in situ, localized prostate cancer, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated 5 years prior to entry is permitted
• Progression of LM at any time point prior to transplant surgery
• LM show no major vascular invasion: no vena cava involvement and no porta hepatis involvement as seen on scans (including PET-CT), or through endoscopic ultrasound and exploratory laparotomy sampling of porta hepatis lymph nodes
• BRAF+ mutation or microsatellite instability of either primary tumor or LM
• Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min
• Pulmonary insufficiency (history of chronic obstructive pulmonary disease and FEV1 /FVC \< 75%)
• History of cardiac disease:
• Congestive heart failure \> New York Heart Association (NYHA) class 2
• Non-revascularized coronary artery disease
• Uncontrolled hypertension (two systolic blood pressure readings greater than 150 in past 2 visits)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Study Officials

• David P Al-Adra, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-center, open-label, two-stage recruitment * pilot study of 5 recipients to determine if LDLT is a suitable treatment for patients with non-resectable LM with 3 years of follow-up, if Overall Survival greater than 60%, then * stage two recruitment focusing on accruing additional recipients will commence. * control group of participants that sign the informed consent and are enrolled in the study but do not undergo LDLT due to a lack of an eligible donor

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 3, 2022
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 6, 2026

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)