Back to resultsA Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma
Primary Purpose
Hepatocellular Carcinoma
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Becavizumab
Transarterial chemoembolization (TACE)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
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 macrovascular invasion (MVI)
- 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
Sites / Locations
- Peking University First Hospital
- Beijing You An Hospital; Digestive Dept
- Beijing Tsinghua Changgung Hospital
- Peking University People's Hospital
- Hunan Cancer Hospital
- Sichuan Cancer Hospital
- West China Hospital, Sichuan University; Surgical Oncology
- The First Affiliated Hospital, Chongqing Medical University
- Southwest Hospital , Third Military Medical University
- The First Affiliated Hospital Of Fujian Medical University
- Mengchao Hepatobiliary Hospital Of Fujian Medical University
- The 900th Hospital of PLA joint service support force
- Fujian Cancer Hospital
- The First Affiliated Hospital of Sun Yat-sen University
- Sun Yet-sen University Cancer Center
- Nanfang Hospital, Southern Medical University
- Harbin Medical University Cancer Hospital; internal medicine
- Anhui Provincial Hospital
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
- Jiangsu Cancer Hospital
- Guangxi Cancer Hospital of Guangxi Medical University
- The First Affiliate Hospital of Guangxi Medical University
- Zhongshan Hospital Fudan Unvierstiy
- Fudan University Shanghai Cancer Center
- Renji Hospital Shanghai Jiaotong University School of Medicine
- Shengjing Hospital of China Medical University
- Tianjin Cancer Hospital; Surgical Department
- The First Affiliated Hospital of Xi'an Jiaotong University; Hepatobiliary surgery Department
- Xi'an Inernational Medical Center Hospital
- Zhejiang Cancer Hospital
- Henan Cancer Hospital
- Zhuhai People's Hospital
- Aichi Cancer Center
- Chiba University Hospital
- Kurume University Hospital
- Hiroshima University Hospital
- Yokohama City University Medical Center
- Kanagawa Cancer Center
- Kitasato University Hospital
- Osaka University Hospital
- Kindai University Hospital
- Toranomon Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A: atezolizumab + bevacizumab + TACE
Arm B: TACE alone
Arm Description
Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
Participants will receive on-demand transarterial chemoembolization.
Outcomes
Primary Outcome Measures
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).
Overall Survival (OS)
Overall survival (OS) after enrollment is defined as the time from randomization to death from any cause.
Secondary Outcome Measures
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 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 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.
Objective Response Rate (ORR), as Determined by Investigator
Objective response (OR) is defined as a complete or partial response, as determined by investigator.
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 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.
Percentage of Participants With Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04712643
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 12, 2021 (Actual)
Primary Completion Date
February 28, 2029 (Anticipated)
Study Completion Date
February 28, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
342 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: atezolizumab + bevacizumab + TACE
Arm Type
Experimental
Arm Description
Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
Arm Title
Arm B: TACE alone
Arm Type
Active Comparator
Arm Description
Participants will receive on-demand transarterial chemoembolization.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Becavizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.
Intervention Type
Device
Intervention Name(s)
Transarterial chemoembolization (TACE)
Intervention Description
TACE will be performed by clinical demand.
Primary Outcome Measure Information:
Title
TACE Progression-Free Survival (TACE PFS) as Determined by Investigator
Description
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)
Title
Overall Survival (OS)
Description
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)
Secondary Outcome Measure Information:
Title
Time to Untreatable (unTACEable) Progression (TTUP) as Determined by Investigator
Description
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)
Title
Time to Progression (TTP) as Determined by Investigator
Description
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)
Title
Time to Extrahepatic Spread (EHS) as Determined by Investigator
Description
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)
Title
Objective Response Rate (ORR), as Determined by Investigator
Description
Objective response (OR) is defined as a complete or partial response, as determined by investigator.
Time Frame
Randomization up to approximately 46 months
Title
Duration of Responses (DOR) as Determined by Investigator
Description
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)
Title
Time to Deterioration (TTD)
Description
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)
Title
Percentage of Participants With Adverse Events
Time Frame
Baseline up to approximately 94 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing City
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing You An Hospital; Digestive Dept
City
Beijing City
ZIP/Postal Code
100069
Country
China
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing City
ZIP/Postal Code
102218
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha CITY
ZIP/Postal Code
410013
Country
China
Facility Name
Sichuan Cancer Hospital
City
Chengdu City
ZIP/Postal Code
610041
Country
China
Facility Name
West China Hospital, Sichuan University; Surgical Oncology
City
Chengdu City
ZIP/Postal Code
610041
Country
China
Facility Name
The First Affiliated Hospital, Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Southwest Hospital , Third Military Medical University
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
The First Affiliated Hospital Of Fujian Medical University
City
Fuzhou City
ZIP/Postal Code
350005
Country
China
Facility Name
Mengchao Hepatobiliary Hospital Of Fujian Medical University
City
Fuzhou City
ZIP/Postal Code
350025
Country
China
Facility Name
The 900th Hospital of PLA joint service support force
City
Fuzhou
ZIP/Postal Code
110016
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
ZIP/Postal Code
350014
Country
China
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou City
ZIP/Postal Code
510080
Country
China
Facility Name
Sun Yet-sen University Cancer Center
City
Guangzhou City
ZIP/Postal Code
510663
Country
China
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Harbin Medical University Cancer Hospital; internal medicine
City
Harbin City
ZIP/Postal Code
150081
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
ZIP/Postal Code
230001
Country
China
Facility Name
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
City
Nanjing City
ZIP/Postal Code
210029
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing City
ZIP/Postal Code
211100
Country
China
Facility Name
Guangxi Cancer Hospital of Guangxi Medical University
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
The First Affiliate Hospital of Guangxi Medical University
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
Zhongshan Hospital Fudan Unvierstiy
City
Shanghai City
ZIP/Postal Code
200032
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Facility Name
Renji Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai City
ZIP/Postal Code
200127
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
ShenYang
ZIP/Postal Code
110004
Country
China
Facility Name
Tianjin Cancer Hospital; Surgical Department
City
Tianjin City
ZIP/Postal Code
300060
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University; Hepatobiliary surgery Department
City
Xi'an
ZIP/Postal Code
710049
Country
China
Facility Name
Xi'an Inernational Medical Center Hospital
City
Xi'an
ZIP/Postal Code
710119
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
Zhuhai People's Hospital
City
Zhuhai
ZIP/Postal Code
519099
Country
China
Facility Name
Aichi Cancer Center
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Kurume University Hospital
City
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Kitasato University Hospital
City
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Learn more about this trial
A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma
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