Methods and analysis
unresectable HCC
ONCOLOGY
TERTIO study is a multicentre, non-comparative, randomized, open-label phase II trial, to evaluate a strategy combining UCPVax, atezolizumab and bevacizumab in advanced patients with unresectable HCC. This study was developed by the “National Institute of Health and Medical Research (INSERM), Unit 1098” and “Clinical Investigational Center (CIC) 1431”. The study is sponsored by University Hospital of Besançon and supported by INCa and DGOS (PHRC-K22-127), by the GERCOR collaborative group and A.R.C.A.D. Foundation. The data management, the methodology and the statistical analyses are undertaken by the “Methodology and Quality of Life Unit in Oncology” of the University Hospital of Besançon. The trial is registered on the clinicaltrials.gov database (NCT05528952).The study has received the approval from Committee for Protection of Persons and by the French National Agency for the Safety of Medicines and Health Products on August 10, 2022 by Clinical Trials Information System (CTIS) portal, and will be conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice.