What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantation, or The patients will receive two procedures of TACE prior to liver transplantation. The registry lists allocation as randomized. In this randomly assigned study it should be investigated, whether and to what extent standard TACE treatment combined with additional stereotactic body radiotherapy (SBRT) leads to improved outcomes for patients with HCC when used as a bridging therapy prior to liver transplantation.
They plan to enroll about 44 people at München. Taking part typically means a procedure as part of the study plus check-ins.
Official title (unrewritten)
Transarterial Chemoembolization (TACE) and Stereotactic Body Radiation (SBRT) in Patients With Hepatocellular Carcinoma (HCC) Prior to Liver Transplantation A Randomized, 2-arm Phase II Study Comparing the Combination of Transarterial Chemoembolization (TACE) and Stereotactic Body Radiation (SBRT) Versus TACE Alone in Patients With Hepatocellular Carcinoma as Bridging to Liver Transplantation With Regard to Explant Histopathology
Interventions: Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantation, The patients will receive two procedures of TACE prior to liver transplantation
Primary outcome (registry wording): Primary Endpoint: histopathological response (presence of vital tumor tissue) in explant histopathology after liver transplantation.