A prospective observational registry study on transplantation of liver outcomes in patients with a history of cancer within the past five years: Evaluating eligibility for liver transplantation

Background: One of the current contraindications to LT is a prior history of extrahepatic malignancy. Candidates with a history of malignancy must have undergone definitive treatment and demonstrated adequate tumor-free survival before being considered for LT. The challenge of transplanting patients with a prior malignancy arises from the increased risk of malignancy recurrence under immunosuppressive therapy and concerns regarding equitable organ allocation given the limited donor pool. Studies have shown that solid organ transplantation, particularly in kidney transplant recipients, is associated with a high recurrence rate of pretransplant malignancies. However, LT differs from kidney transplantation in that it requires lower levels of immunosuppression, potentially reducing the risk of malignancy recurrence. Unlike kidney failure, where dialysis can serve as a bridging therapy, there is no equivalent long-term management strategy for patients with liver failure. The optimal timing of LT is therefore critical. In patients with a prior extrahepatic malignancy, the necessary waiting period for oncologic remission may delay LT eligibility. However, during this period, disease progression may result in the development of additional contraindications, ultimately precluding LT and negating its potential benefits. A recent analysis of a large public database on patients with pretransplant malignancies demonstrates comparable overall survival rates following double lung transplantation (DLT) to those observed in patients without a history of malignancy. Currently, the Double Lung Transplant Registry for Lung-Limited Malignancies (DREAM) is underway, including a cohort of patients undergoing DLT for respiratory failure with a history of malignancy within the past five years. This prospective observational registry aims to better understand the long-term outcomes in patients undergoing liver transplantation with a history of malignancy within 5 years in the clinical programs at Northwestern Medicine. The study will assess the impact of a standardized approach to patient selection and postoperative management on long-term survival following liver transplantation in this population. Their clinical course, including overall survival, disease-free survival, and graft failure, will be monitored. Methods: This is a prospective observational registry trial for patients with liver failure who have a history of cancer within the last five years, and who meet the inclusion criteria for liver transplantation at Northwestern Medicine and participating centers. Patients referred to Northwestern Medicine who are undergoing liver transplantation and have the following diseases will be assessed and screened for this registry: Diseases included: 1. Liver failure patients with a history of previously treated non-liver primary cancer within the last 5 years (in remission) 2. Liver failure patients with concomitant active primary cancer who undergo curative resection after LT. Clinical trial registry number : Enrollment began 8/18/25. Trial is open and continues to enroll participants as of 11/18/25.