Y-90 personalised dosimetry TARE versus DEB-TACE in the treatment of BCLC B hepatocellular carcinoma: a multicentre, randomised, open-label clinical trial

Abstract

BACKGROUND: Liver tumours are a major health problem worldwide with a rising incidence and increasing prevalence of intermediate and advanced stages with a poor prognosis. This has led to the development and use of new therapeutic procedures, including various minimally invasive intra-arterial local treatments, such as TARE. Transarterial Radioembolisation (TARE) is presented as a promising therapeutic alternative to the loco-regional treatments accepted in clinical practice, but until now, it has not been able to show a significant increase in terms of survival in intermediate HCC. Due to that, it has not replaced TACE as a gold-standard treatment for Intermediate Stage disease according to the BCLC system (BCLC B). The role of radioembolisation is still to be defined and further trials are necessary to delineate which group of patients could benefit from this therapy. Scientific evidence supports that personalised dosimetry will improve outcomes in clinical practice and future clinical trials must be conducted using this approach. If we demonstrate that personalised dosimetry improves the outcomes of this technique, it would be the beginning of a paradigm shift and would justify the lack of increased survival in all current evidence where personalised dosimetry has not been used. OBJECTIVE: The aim of this study is to demonstrate that personalised dosimetry TARE offers better outcomes than DEB-TACE in patients diagnosed with BCLC B Hepatocellular Carcinoma. DESING: This study will be carried out through a multicentric, prospective, randomised, open-label clinical trial performed among fifteen hospitals belonging to the National Health System from January 2022 until December 2026. PARTICIPANTS: Study subjects will consist of 18 years or older reference population of each of the hospitals participating in this clinical trial, that are diagnosed of an intermediate stage hepatocellular carcinoma BCLC class B. METHODS: A non-probabilistic consecutive method will be used. Patients treated in the hospitals included in the study who meet the inclusion and exclusion criteria will be requested to participate. 756 patients will be assigned randomly to one of the two intervention groups on a 1:1 ratio: Control group TACE n=378 and Intervention group TARE n=378. A two-year follow-up will be carried out