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Hepatocellular CarcinomaPhase 3NCT04712643

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

A Phase 3 study testing Atezolizumab, Becavizumab and Transarterial chemoembolization (TACE) in people with Hepatocellular Carcinoma, run by Hoffmann-La Roche at 40 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Atezolizumab, Becavizumab and Transarterial chemoembolization (TACE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
342 participants
Where
40 sitesin 2 countries
Study dates
12 Mar 2021to 1 Feb 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

40 sites in 2 countries.

40 sites in 2 countries

China30 sites

  • Anhui Provincial Hospital

    Anhui, 230001

  • Peking University First Hospital

    Beijing, 100034

  • Peking University People's Hospital

    Beijing, 100044

  • Beijing You An Hospital

    Beijing, 100069

  • Beijing Tsinghua Changgung Hospital

    Beijing, 102218

  • Hunan Cancer Hospital

    Changsha, 410013

  • West China Hospital, Sichuan University

    Chengdu

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016

  • Southwest Hospital , Third Military Medical University

    Chongqing, 400038

  • The 900th Hospital of PLA joint service support force

    Fuzhou, 110016

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, 350005

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • Mengchao Hepatobiliary Hospital Of Fujian Medical University

    Fuzhou, 350025

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

    Nanjing, 210029

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021

  • The First Affiliate Hospital of Guangxi Medical University

    Nanning, 530021

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200127

  • Zhongshan Hospital Fudan Unvierstiy

    Shanghai

  • Shengjing Hospital of China Medical University

    Shenyang, 110004

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • Xi'an Inernational Medical Center Hospital

    Xi'an

  • Henan Cancer Hospital

    Zhengzhou, 450008

  • Zhuhai People's Hospital

    Zhuhai, 519099

Other trials in China

Japan10 sites

  • Aichi Cancer Center

    Aichi, 464-8681

  • Chiba University Hospital

    Chiba, 260-8677

  • Kurume University Hospital

    Fukuoka, 830-0011

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Yokohama City University Medical Center

    Kanagawa, 232-0024

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Kitasato University Hospital

    Kanagawa, 252-0375

  • The University of Osaka Hospital

    Osaka, 565-0871

  • Kindai University Hospital

    Osaka, 589-8511

  • Toranomon Hospital

    Tokyo, 105-8470

Other trials in Japan

About this study

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

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.

Being tested
Atezolizumab, Becavizumab, Transarterial chemoembolization (TACE)
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    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.

  • BecavizumabDrug

    Also called Avastin

    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)Device

    TACE will be performed by clinical demand.

Study groups in NCT04712643
Study groupRoleWhat they receive
Arm A: atezolizumab + bevacizumab + TACEExperimentalParticipants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
Receives: Drug: Atezolizumab; Drug: Becavizumab; Device: Transarterial chemoembolization (TACE)
Arm B: TACE aloneActive comparatorParticipants will receive on-demand transarterial chemoembolization.
Receives: Device: Transarterial chemoembolization (TACE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Randomization to untreatable progression or TACE failure/refractoriness or death (up to approximately 46 months)

  2. Overall Survival (OS)

    Overall survival (OS) after enrollment is defined as the time from randomization to death from any cause.

    Measured: Randomization to death from any cause (up to approximately 94 months)

Secondary outcomes (8)

  1. 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.

    Measured: Randomization to untreatable (unTACEable) progression (up to approximately 46 months)

  2. 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.

    Measured: Randomization to unTACEable progression or TACE failure/refractoriness (up to approximately 46 months)

  3. 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.

    Measured: Randomization to first evidence of EHS (up to approximately 46 months)

  4. Objective Response Rate (ORR), as Determined by Investigator

    Objective response (OR) is defined as a complete or partial response, as determined by investigator.

    Measured: Randomization up to approximately 46 months

  5. 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.

    Measured: First occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first)(up to approximately 46 months)

  6. Progression Free Survival (PFS)

    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.

    Measured: Randomization to first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 94 monthsJ)

  7. 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.

    Measured: Randomization to first deterioration (up to approximately 94 months)

  8. Percentage of Participants With Adverse Events

    Measured: Baseline up to approximately 94 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start12 Mar 2021
  3. Primary completion1 Feb 2029 (estimated)
  4. Study completion1 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
342 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04712643
Sponsor's protocol ID
ML42612
Status last verified
Oct 2026
First submitted
14 Jan 2021
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Kudo M, Ogasawara S, Liu R, Gu S, Wang K, Zhao M, Hu H, Liu Z, Lin K, Liu J, Lin Z, Zhang Y, Peng T, Song J, Ueno M, Zhu J, Bai L, Tong L, Shi Y, Han G, Dong J. On-demand transarterial chemoembolisation combined with atezolizumab and bevacizumab in patients with untreated hepatocellular carcinoma (TALENTACE): a multicentre, randomised, open-label, phase 3 trial. Lancet Gastroenterol Hepatol. 2026 Aug 25:S2468-1253(26)00212-8. doi: 10.1016/S2468-1253(26)00212-8. Online ahead of print.

    PubMed 42641632

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab, Becavizumab and Transarterial chemoembolization (TACE) in people with Hepatocellular Carcinoma, run by Hoffmann-La Roche at 40 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in China, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04712643, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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