TRANSMIT: Utilizing discarded livers from donors with a history of cancer for patients lacking access to standard allocation - A compassionate use exploratory study
Dominik Thomas Koch , Malte Schirren , Severin Jacobi , Christian Lange , Jens Werner , Dionysios Koliogiannis , Markus Guba
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引用次数: 0
Abstract
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.
期刊介绍:
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.