Atezolizumab/Bevacizumab Followed by On-demand TACE or Initial Synchronous Treatment With TACE and Atezolizumab/Bevacizumab
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Interventions
- Combination Product: Atezolizumab Injection, Bevacizumab Injection
- Registration Number
- NCT04224636
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 106
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Up-front Atezo/Bev, then TACE Atezolizumab Injection, Bevacizumab Injection 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 Atezo/Bev combined with TACE Atezolizumab Injection, Bevacizumab Injection 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.
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) 24 months Response is defined by RECIST 1.1 and mRECIST
- Secondary Outcome Measures
Name Time Method Median overall survival (mOS) 24 months Defined as the time from treatment initiation until death
24-months survival rate 24 months Percentage of patients alive after 24 months since randomization
Time to deterioration of liver function 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)
Disease control rate (DCR) 24 months Defined as the percentage of patients who have achieved complete response, partial response and stable disease
Time to first TACE (arm A) 24 months Defined as time from randomization to disease to the first TACE
Quality of life (QOL) 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
Time to untreatable progression 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
Time to stage-progression 24 months Defined as time from randomization to disease progression to BCLC C stage
Complete response rate (CRR) 24 months Defined by the percentage of patients with disappearance of tumor manifestation at radiological evaluation
Adverse Events 24 months Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Progression-free survival (PFS) 24 months Progression is defined according RECIST 1.1 and mRECIST
Trial Locations
- Locations (7)
Klinikum Rechts der Isar of the Technical University Munich
🇩🇪Munich, Germany
Würzburg University Hospital
🇩🇪Würzburg, Germany
University Hospital Regensburg
🇩🇪Regensburg, Germany
University of Bonn
🇩🇪Bonn, Germany
Hospital of the University of Munich
🇩🇪Munich, Germany
University Hospital Cologne
🇩🇪Köln, Germany
University Hospital Tübingen
🇩🇪Tübingen, Germany