Clinical trial NCT04712643: A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2021-01-15
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: TACE Progression-Free Survival (TACE PFS) as Determined by Investigator
timeFrame: Randomization to untreatable progression or TACE failure/refractoriness or death (up to approximately 46 months)
measure: Overall Survival (OS)
timeFrame: Randomization to death from any cause (up to approximately 94 months)
Secondary outcomes:
measure: Time to Untreatable (unTACEable) Progression (TTUP) as Determined by Investigator
timeFrame: Randomization to untreatable (unTACEable) progression (up to approximately 46 months)
measure: Time to Progression (TTP) as Determined by Investigator
timeFrame: Randomization to unTACEable progression or TACE failure/refractoriness (up to approximately 46 months)
measure: Time to Extrahepatic Spread (EHS) as Determined by Investigator
timeFrame: Randomization to first evidence of EHS (up to approximately 46 months)
measure: Objective Response Rate (ORR), as Determined by Investigator
timeFrame: Randomization up to approximately 46 months
measure: Duration of Responses (DOR) as Determined by Investigator
timeFrame: First occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first)(up to approximately 46 months)
measure: Progression Free Survival (PFS)
timeFrame: Randomization to first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 94 monthsJ)
measure: Time to Deterioration (TTD)
timeFrame: Randomization to first deterioration (up to approximately 94 months)
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to approximately 94 months
Other outcomes:
Locations:
city: Anhui
country: China
facility: Anhui Provincial Hospital
city: Beijing City
country: China
facility: Peking University First Hospital
city: Beijing City
country: China
facility: Beijing Tsinghua Changgung Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Beijing You An Hospital
city: Changsha City
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: The First Affiliated Hospital, Chongqing Medical University
city: Chongqing
country: China
facility: Southwest Hospital , Third Military Medical University
city: Fuzhou City
country: China
facility: The First Affiliated Hospital Of Fujian Medical University
city: Fuzhou City
country: China
facility: Mengchao Hepatobiliary Hospital Of Fujian Medical University
city: Fuzhou
country: China
facility: The 900th Hospital of PLA joint service support force
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yet-sen University Cancer Center
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin City
country: China
facility: Harbin Medical University Cancer Hospital
city: Nanjing City
country: China
facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Nanning
country: China
facility: Guangxi Cancer Hospital of Guangxi Medical University
city: Nanning
country: China
facility: The First Affiliate Hospital of Guangxi Medical University
city: Shanghai City
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan Unvierstiy
city: ShenYang
country: China
facility: Shengjing Hospital of China Medical University
city: Tianjin City
country: China
facility: Tianjin Cancer Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xi'an
country: China
facility: Xi'an Inernational Medical Center Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhuhai
country: China
facility: Zhuhai People's Hospital
city: Aichi
country: Japan
facility: Aichi Cancer Center
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Kanagawa
country: Japan
facility: Yokohama City University Medical Center
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kanagawa
country: Japan
facility: Kitasato University Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Osaka
country: Japan
facility: Kindai University Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: