Aim of the study is to evaluate the efficacy of up-front atezolizumab/ bevacizumab (Atezo/Bev) followed by on-demand selective transarterial chemoembolization (sdTACE) and of initial synchronous treatment with TACE and Atezo/Bev in the treatment of unresectable HCC patients.
Patient's signed informed consent
Age ≥18 years at time of signing Informed Consent Form
Ability to comply with the study protocol, according to investigator's judgement
Life expectancy of at least 12 weeks
Diffuse HCC or presence of vascular invasion or extrahepatic spread or more than 7 lesions or at least one lesion >= 7 cm
Clinically relevant ascites
Uncontrolled pleural effusion or pericardial effusion
History or presence of hepatic encephalopathy
Parallel
Atezolizumab Injection, Bevacizumab Injection
Combination productAtezolizumab and Bevacizumab will be administered prior to or in combination with TACE
Overall response rate (ORR)
Response is defined by RECIST 1.1 and mRECIST
Median overall survival (mOS)
Defined as the time from treatment initiation until death
Progression-free survival (PFS)
Progression is defined according RECIST 1.1 and mRECIST
24-months survival rate
Percentage of patients alive after 24 months since randomization
Complete response rate (CRR)
Defined by the percentage of patients with disappearance of tumor manifestation at radiological evaluation
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