A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma

NCT04712643 · tracked via the Priya Life Science China tracker

Sponsor

Hoffmann-La Roche

Phase

Phase 3

Started

2021-03-12

Last updated

2026-07-29

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

AtezolizumabBecavizumabTransarterial chemoembolization (TACE)

Atezolizumab: 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.

Becavizumab: Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.

Transarterial chemoembolization (TACE): TACE will be performed by clinical demand.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

TACE Progression-Free Survival (TACE PFS) as Determined by Investigator — Randomization to untreatable progression or TACE failure/refractoriness or death (up to approximately 46 months)
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).
Overall Survival (OS) — Randomization to death from any cause (up to approximately 94 months)
Overall survival (OS) after enrollment is defined as the time from randomization to death from any cause.

Trial sites (40)

Facility	City	Region
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
The First Affiliated Hospital Of Fujian Medical University	Fuzhou	China
Fujian Cancer Hospital	Fuzhou	China
Mengchao Hepatobiliary Hospital Of Fujian Medical University	Fuzhou	China
Sun Yet-sen University Cancer Center	Guangzhou	China
Nanfang Hospital, Southern Medical University	Guangzhou	China
Zhejiang Cancer Hospital	Hangzhou	China
Harbin Medical University Cancer Hospital	Harbin	China
Jiangsu Cancer Hospital	Nanjing	China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)	Nanjing	China
Guangxi Cancer Hospital of Guangxi Medical University	Nanning	China
The First Affiliate Hospital of Guangxi Medical University	Nanning	China
Fudan University Shanghai Cancer Center	Shanghai	China
Renji Hospital Shanghai Jiaotong University School of Medicine	Shanghai	China
Zhongshan Hospital Fudan Unvierstiy	Shanghai	China
Shengjing Hospital of China Medical University	Shenyang	China
Tianjin Cancer Hospital	Tianjin	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	China
Zhuhai People's Hospital	Zhuhai	China
Aichi Cancer Center	Aichi	Japan
Chiba University Hospital	Chiba	Japan
Kurume University Hospital	Fukuoka	Japan
Hiroshima University Hospital	Hiroshima	Japan
Yokohama City University Medical Center	Kanagawa	Japan
Kanagawa Cancer Center	Kanagawa	Japan
Kitasato University Hospital	Kanagawa	Japan
The University of Osaka Hospital	Osaka	Japan
Kindai University Hospital	Osaka	Japan
Toranomon Hospital	Tokyo	Japan

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04712643 on ClinicalTrials.gov ↗ ← All trials in China