1. 24-months survival rate (Time Frame - 24 months): Percentage of patients alive after 24 months since randomization
Secondary outcome:
1. Median overall survival (mOS) (Time Frame - 24 months): Defined as the time from treatment initiation until death
2. Progression-free survival (PFS) (Time Frame - 24 months): Progression is defined according RECIST 1.1 and mRECIST
3. Overall response rate (ORR) (Time Frame - 24 months): Response is defined by RECIST 1.1 and mRECIST
4. Complete response rate (CRR) (Time Frame - 24 months): Defined by the percentage of patients with disappearance of tumor manifestation at radiological evaluation
5. Disease control rate (DCR) (Time Frame - 24 months): Defined as the percentage of patients who have achieved complete response, partial response and stable disease
6. Time to deterioration of liver function (Time Frame - 24 months): Defined as time from randomization to worsening of CTCAE grade for any of these parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, albumin, and international normalized ratio (INR)
7. Time to untreatable progression (Time Frame - 24 months): defined as time from randomization to progression not amenable to local treatment as per protocol, occurrence of vascular invasion or of extrahepatic spread, worsening of liver function to Child-Pugh score 8 or higher
8. Time to stage-progression (Time Frame - 24 months): Defined as time from randomization to disease progression to BCLC C stage
9. Time to first TACE (arm A) (Time Frame - 24 months): Defined as time from randomization to disease to the first TACE
10. Quality of life (QOL) (Time Frame - 24 months): Standardized assessment will be performed by using EORTC QLQ-C30 - European Organisation for Research and Treatment of Cancer - Quality of Life Core Questionnaire 30 items
11. Quality of life (QOL) (Time Frame - 24 months): Standardized assessment will be performed by using EORTC QLQ-HCC18 - European Organisation for Research and Treatment of Cancer - Quality of Life Core Questionnaire - Hepatocellular carcinoma module 18
12. Adverse Events (Time Frame - 24 months): Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Experimental: Up-front Atezo/Bev, then TACE Patients will receive atezolizumab and bevacizumab iv every three weeks for up to 24 months. Upon detection of at least one unequivocal progressive hepatic lesion, selective TACE directed against progressive lesion(s) (sdTACE) will be performed. RFA or MWA are permitted as alternative to TACE to treat one or more lesion that cannot be reasonably selectively targeted by TACE
Experimental: Atezo/Bev combined with TACE First TACE will be performed as selectively as possible against all viable tumor lesions. Atezo/Bev will be initiated within three days from TACE. Upon detection of at least one unequivocal progressive hepatic lesion, treatment with Atezo/Bev will be continued if RFA or MWA can be used to treat this/these progressive lesion.
Atezolizumab Injection, Bevacizumab Injection (Chemoembolisation (TACE)): Atezolizumab and Bevacizumab will be administered prior to or in combination with TACE
Quelle: ClinicalTrials.gov
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"Atezolizumab/Bevacizumab Followed by On-demand TACE or Initial Synchronous Treatment With TACE and Atezolizumab/Bevacizumab"
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