Living Donor Liver Transplantation for CRC Liver Metastases (NCT05175092) | Clinical Trial Compass
WithdrawnNot Applicable
Living Donor Liver Transplantation for CRC Liver Metastases
Stopped: Slow accrual
United States0Started 2023-11
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Recipient Inclusion Criteria
In order to be eligible to participate in this study, a potential recipient must meet all of the following criteria prior to transplant procedure:
* General inclusion criteria:
* 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
* Cancer-related inclusion criteria:
* 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 reg…