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NCT Number: NCT04712643

A Study of TACE Combined With Atezolizumab Plus Bevacizumab or 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anhui Provincial Hospital, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atezolizumab

Drug

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

Becavizumab

Drug

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

Transarterial chemoembolization (TACE)

Device

TACE will be performed by clinical demand.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Percentage of Participants With Adverse Events

    Time frame: Baseline up to approximately 94 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Jan 15, 2021
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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