This study will evaluate the efficacy and safety of atezolizumab plus bevacizumab combined with on-demand TACE compared to on-demand TACE alone in participants with hepatocellular carcinoma who are at high risk of poorer outcome following TACE treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
342
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until participant experience loss of clinical benefit as evaluated by the investigator or unacceptable toxicity or withdrawal of informed consent.
Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.
TACE will be performed by clinical demand.
TACE Progression-Free Survival (TACE PFS) as Determined by Investigator
TACE PFS is defined as the time from randomization to untreatable progression or TACE failure/refractoriness or any cause of death, whichever occurs first, as determined by the investigator (INV).
Time frame: Randomization to untreatable progression or TACE failure/refractoriness or death (up to approximately 46 months)
Overall Survival (OS)
Overall survival (OS) after enrollment is defined as the time from randomization to death from any cause.
Time frame: Randomization to death from any cause (up to approximately 94 months)
Time to Untreatable (unTACEable) Progression (TTUP) as Determined by Investigator
INV-assessed TTUP is defined as time from randomization to untreatable (unTACEable) progression, as determined by investigator.
Time frame: Randomization to untreatable (unTACEable) progression (up to approximately 46 months)
Time to Progression (TTP) as Determined by Investigator
INV-assessed TTP is defined as the time from randomization to unTACEable progression or TACE failure/refractoriness (as defined above), as determined by investigator.
Time frame: Randomization to unTACEable progression or TACE failure/refractoriness (up to approximately 46 months)
Time to Extrahepatic Spread (EHS) as Determined by Investigator
INV-assessed time to EHS is defined as the time from randomization to the first evidence of EHS, as determined by investigator.
Time frame: Randomization to first evidence of EHS (up to approximately 46 months)
Objective Response Rate (ORR), as Determined by Investigator
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Anhui Provincial Hospital
Anhui, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Beijing You An Hospital
Beijing, China
Beijing Tsinghua Changgung Hospital
Beijing, China
Hunan Cancer Hospital
Changsha, China
West China Hospital, Sichuan University
Chengdu, China
The First Affiliated Hospital, Chongqing Medical University
Chongqing, China
Southwest Hospital , Third Military Medical University
Chongqing, China
The 900th Hospital of PLA joint service support force
Fuzhou, China
...and 30 more locations
Objective response (OR) is defined as a complete or partial response, as determined by investigator.
Time frame: Randomization up to approximately 46 months
Duration of Responses (DOR) as Determined by Investigator
INV-assessed DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by INV.
Time frame: First occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first)(up to approximately 46 months)
Progression Free Survival (PFS)
Progression free survival (PFS) is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Time frame: Randomization to first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 94 monthsJ)
Time to Deterioration (TTD)
TTD is defined as the time from randomization to first deterioration in the patient-reported GHS/QoL, physical function, or role function scales of the EORTC QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.
Time frame: Randomization to first deterioration (up to approximately 94 months)
Percentage of Participants With Adverse Events
Time frame: Baseline up to approximately 94 months