A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma
A Phase III, Open-Label, Randomized Study of On-Demand TACE Combined With Atezolizumab Plus Bevacizumab (Atezo/Bev) or On-Demand TACE Alone in Patients With Untreated Heaptocellular Carcionma
1 other identifier
interventional
342
2 countries
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hepatocellular-carcinoma
Started Mar 2021
Longer than P75 for phase_3 hepatocellular-carcinoma
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2021
CompletedFirst Posted
Study publicly available on registry
January 15, 2021
CompletedStudy Start
First participant enrolled
March 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
April 29, 2026
April 1, 2026
7.9 years
January 14, 2021
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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).
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.
Randomization to death from any cause (up to approximately 94 months)
Secondary Outcomes (8)
Time to Untreatable (unTACEable) Progression (TTUP) as Determined by Investigator
Randomization to untreatable (unTACEable) progression (up to approximately 46 months)
Time to Progression (TTP) as Determined by Investigator
Randomization to unTACEable progression or TACE failure/refractoriness (up to approximately 46 months)
Time to Extrahepatic Spread (EHS) as Determined by Investigator
Randomization to first evidence of EHS (up to approximately 46 months)
Objective Response Rate (ORR), as Determined by Investigator
Randomization up to approximately 46 months
Duration of Responses (DOR) as Determined by Investigator
First occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first)(up to approximately 46 months)
- +3 more secondary outcomes
Study Arms (2)
Arm A: atezolizumab + bevacizumab + TACE
EXPERIMENTALParticipants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
Arm B: TACE alone
ACTIVE COMPARATORParticipants will receive on-demand transarterial chemoembolization.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of HCC by histology/ cytology or clinical criteria
- Eligible for TACE treatment
- No prior systemic therapy for HCC, especially immunotherapy
- No prior locoregional therapy to the target lesion(s)
- At least one measurable untreated lesion
- ECOG Performance Status of 0-1
- Child-Pugh class A
You may not qualify if:
- Evidence of Vp3/4 and hepatic vein tumor thrombus (HVTT)
- Evidence of extrahepatic spread (EHS)
- Being a candidate for curative treatments
- Any condition representing a contraindication to TACE as determined by the investigators
- Active or history of autoimmune disease or immune deficiency
- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding
- A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
- Evidence of bleeding diathesis or significant coagulopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Anhui Provincial Hospital
Anhui, 230001, China
Peking University First Hospital
Beijing, 100034, China
Peking University People's Hospital
Beijing, 100044, China
Beijing You An Hospital
Beijing, 100069, China
Beijing Tsinghua Changgung Hospital
Beijing, 102218, China
Hunan Cancer Hospital
Changsha, 410013, China
West China Hospital, Sichuan University
Chengdu, China
The First Affiliated Hospital, Chongqing Medical University
Chongqing, 400016, China
Southwest Hospital , Third Military Medical University
Chongqing, 400038, China
The 900th Hospital of PLA joint service support force
Fuzhou, 110016, China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, 350005, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, 350025, China
Sun Yet-sen University Cancer Center
Guangzhou, 510060, China
Nanfang Hospital, Southern Medical University
Guangzhou, 510515, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, 210029, China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021, China
The First Affiliate Hospital of Guangxi Medical University
Nanning, 530021, China
Fudan University Shanghai Cancer Center
Shanghai, 200120, China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200127, China
Zhongshan Hospital Fudan Unvierstiy
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, 110004, China
Tianjin Cancer Hospital
Tianjin, 300060, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Xi'an Inernational Medical Center Hospital
Xi'an, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Zhuhai People's Hospital
Zhuhai, 519099, China
Aichi Cancer Center
Aichi, 464-8681, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
Kurume University Hospital
Fukuoka, 830-0011, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Yokohama City University Medical Center
Kanagawa, 232-0024, Japan
Kanagawa Cancer Center
Kanagawa, 241-8515, Japan
Kitasato University Hospital
Kanagawa, 252-0375, Japan
The University of Osaka Hospital
Osaka, 565-0871, Japan
Kindai University Hospital
Osaka, 589-8511, Japan
Toranomon Hospital
Tokyo, 105-8470, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2021
First Posted
January 15, 2021
Study Start
March 12, 2021
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
February 1, 2029
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing