TRANSMIT: Utilizing discarded livers from donors with a history of cancer for patients lacking access to standard allocation - A compassionate use exploratory study

Background: A substantial number of viable donor livers are discarded due to the donor's underlying malignancy. Concurrently, patients with certain liver malignancies - such as unresectable colorectal cancer liver metastases (CRC-LM), unresectable intrahepatic or perihilar cholangiocarcinoma (iCCC/phCCC), or unresectable hepatocellular carcinoma (HCC) responding to immunotherapy - often face poor survival outcomes and are deemed ineligible for potentially curative liver transplantation. In this context, a rational risk-benefit analysis suggests that transplanting an organ with a theoretical risk of tumor transmission may be justifiable for these patients facing otherwise short-term fatal outcomes. Methods: The TRANSMIT study is a compassionate use exploratory study aimed at assessing the utility and safety of using donor organs from individuals with a current or past history of cancer for liver transplantation in patients with liver malignancies (CRC-LM, i/phCCC, HCC) who are not eligible for regular organ allocation. The study will evaluate the utilization rate of donor organs that would otherwise be discarded, overall survival, progression-free survival, and tumor transmission rates at one and three years, stratified by indication. Discussion: Donor organs from individuals with a current or past history of cancer may represent a valuable and safe resource for expanding the limited donor pool, particularly for patients who lack access to standard organ allocation.