A Randomized, 2-arm Non-comparative Phase II Study on the Efficacy of Atezolizumab and Roche Bevacizumab (Atezo/Bev) Followed by On-demand Selective TACE (sdTACE) Upon Detection of Disease Progression or of Initial Synchronous Treatment With TACE and Atezo/Bev on 24-months Survival Rate in the Treatment of Unresectable Hepatocellular Carcinoma Patients
Who is this study for? Adults with Hepatocellular Carcinoma
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
• HCC with histologically confirmed diagnosis
• Disease that is not amenable to curative surgical and/or local ablation but eligible for TACE
• ECOG Performance Status of 0 or 1
• Child-Pugh class A or B7
• Adequate hematologic and end-organ function
⁃ Negative HIV test at screening
Locations
Other Locations
Germany
University of Bonn
RECRUITING
Bonn
University Hospital Cologne
RECRUITING
Cologne
Hospital of the University of Munich
RECRUITING
Munich
Klinikum Rechts der Isar of the Technical University Munich
RECRUITING
Munich
University Hospital Regensburg
RECRUITING
Regensburg
University Hospital Tübingen
RECRUITING
Tübingen
Würzburg University Hospital
RECRUITING
Würzburg
Contact Information
Primary
Enrico De Toni, MD
enrico.detoni@med.uni-muenchen.de
+49 89 4400 0
Time Frame
Start Date:2020-06-10
Estimated Completion Date:2025-03-01
Participants
Target number of participants:106
Treatments
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.