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

April 28, 2026 updated by: Hoffmann-La Roche

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
342

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Anhui, China, 230001
        • Anhui Provincial Hospital
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, China, 102218
        • Beijing Tsinghua Changgung Hospital
      • Beijing, China, 100069
        • Beijing You An Hospital
      • Changsha, China, 410013
        • Hunan Cancer Hospital
      • Chengdu, China
        • West China Hospital, Sichuan University
      • Chongqing, China, 400016
        • The First Affiliated Hospital, Chongqing Medical University
      • Chongqing, China, 400038
        • Southwest Hospital , Third Military Medical University
      • Fuzhou, China, 350014
        • Fujian Cancer Hospital
      • Fuzhou, China, 110016
        • The 900th Hospital of PLA joint service support force
      • Fuzhou, China, 350005
        • The First Affiliated hospital of Fujian Medical University
      • Fuzhou, China, 350025
        • Mengchao Hepatobiliary Hospital Of Fujian Medical University
      • Guangzhou, China, 510060
        • Sun Yet-sen University Cancer Center
      • Guangzhou, China, 510515
        • Nanfang Hospital, Southern Medical University
      • Hangzhou, China, 310022
        • Zhejiang Cancer Hospital
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Nanjing, China, 210009
        • Jiangsu Cancer Hospital
      • Nanjing, China, 210029
        • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
      • Nanning, China, 530021
        • The First Affiliate Hospital of Guangxi Medical University
      • Nanning, China, 530021
        • Guangxi Cancer Hospital of Guangxi Medical University
      • Shanghai, China, 200120
        • Fudan University Shanghai Cancer Center
      • Shanghai, China, 200127
        • Renji Hospital Shanghai Jiaotong University School of Medicine
      • Shanghai, China
        • Zhongshan Hospital Fudan Unvierstiy
      • Shenyang, China, 110004
        • Shengjing Hospital Of China Medical University
      • Tianjin, China, 300060
        • Tianjin Cancer Hospital
      • Xi'an, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, China
        • Xi'an Inernational Medical Center Hospital
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital
      • Zhuhai, China, 519099
        • Zhuhai People's Hospital
  • Japan
      • Aichi, Japan, 464-8681
        • Aichi Cancer Center
      • Chiba, Japan, 260-8677
        • Chiba University Hospital
      • Fukuoka, Japan, 830-0011
        • Kurume University Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
      • Kanagawa, Japan, 252-0375
        • Kitasato University Hospital
      • Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
      • Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Osaka, Japan, 565-0871
        • The University of Osaka Hospital
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: atezolizumab + bevacizumab + TACE
Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
Drug: 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.
Other Names:
  • Tecentriq
Drug: Becavizumab
Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.
Other Names:
  • Avastin
Device: Transarterial chemoembolization (TACE)
TACE will be performed by clinical demand.
Active Comparator: Arm B: TACE alone
Participants will receive on-demand transarterial chemoembolization.
Device: Transarterial chemoembolization (TACE)
TACE will be performed by clinical demand.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
TACE Progression-Free Survival (TACE PFS) as Determined by Investigator
Time Frame: 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).
Randomization to untreatable progression or TACE failure/refractoriness or death (up to approximately 46 months)
Overall Survival (OS)
Time Frame: 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.
Randomization to death from any cause (up to approximately 94 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Untreatable (unTACEable) Progression (TTUP) as Determined by Investigator
Time Frame: Randomization to untreatable (unTACEable) progression (up to approximately 46 months)
INV-assessed TTUP is defined as time from randomization to untreatable (unTACEable) progression, as determined by investigator.
Randomization to untreatable (unTACEable) progression (up to approximately 46 months)
Time to Progression (TTP) as Determined by Investigator
Time Frame: Randomization to unTACEable progression or TACE failure/refractoriness (up to approximately 46 months)
INV-assessed TTP is defined as the time from randomization to unTACEable progression or TACE failure/refractoriness (as defined above), 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
Time Frame: Randomization to first evidence of EHS (up to approximately 46 months)
INV-assessed time to EHS is defined as the time from randomization to the first evidence of EHS, as determined by investigator.
Randomization to first evidence of EHS (up to approximately 46 months)
Objective Response Rate (ORR), as Determined by Investigator
Time Frame: Randomization up to approximately 46 months
Objective response (OR) is defined as a complete or partial response, as determined by investigator.
Randomization up to approximately 46 months
Duration of Responses (DOR) as Determined by Investigator
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)
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.
First occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first)(up to approximately 46 months)
Time to Deterioration (TTD)
Time Frame: Randomization to first deterioration (up to approximately 94 months)
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.
Randomization to first deterioration (up to approximately 94 months)
Percentage of Participants With Adverse Events
Time Frame: Baseline up to approximately 94 months
Baseline up to approximately 94 months
Progression Free Survival (PFS)
Time Frame: Randomization to first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 94 monthsJ)
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.
Randomization to first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 94 monthsJ)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML42612

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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