Clinical Trials /

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

NCT04712643

Description:

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 unsuitable for curative therapy.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT04712643

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: ML42612
  • NCT ID: NCT04712643

Conditions

  • Hepatocellular Carcinoma

Interventions

DrugSynonymsArms
AtezolizumabTecentriqArm A: atezolizumab + bevacizumab + TACE
BecavizumabAvastinArm A: atezolizumab + bevacizumab + TACE

Purpose

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 unsuitable for curative therapy.

Trial Arms

NameTypeDescriptionInterventions
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.
  • Atezolizumab
  • Becavizumab
Arm B: TACE aloneActive ComparatorParticipants will receive on-demand transarterial chemoembolization.

    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
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:TACE Progression-Free Survival (TACE PFS) as Determined by IRC
    Time Frame:Randomization to untreatable progression or TACE failure/refractoriness or death (up to approximately 48 months)
    Safety Issue:
    Description:TACE PFS is defined as the time from randomization to untreatable progression or TACE failure/refractoriness and any cause of death, as determined by the independent review committee (IRC).

    Secondary Outcome Measures

    Measure:TACE PFS as Determined by Investigator
    Time Frame:Randomization to untreatable progression or TACE failure/refractoriness or death (up to approximately 48 months)
    Safety Issue:
    Description:TACE PFS as determined by the investigator.
    Measure:Time to Untreatable (unTACEable) Progression (TTUP)
    Time Frame:Randomization to Child-Pugh B8 or worse, intrahepatic tumor progression, with new lesions NOT defined as tumor progression, MVI or EHS (up to approximately 48 months)
    Safety Issue:
    Description:Time to untreatable (unTACEable) progression (TTUP) is defined as time from randomization to Child-Pugh B8 or worse, intrahepatic tumor progression, with new lesions NOT defined as tumor progression, MVI or EHS, as determined by the IRC and investigator.
    Measure:Time to Progression (TTP)
    Time Frame:Randomization to unTACEable progression or TACE failure/refractoriness (up to approximately 48 months)
    Safety Issue:
    Description:Time to progression (TTP) is defined as the time from randomization to unTACEable progression or TACE failure/refractoriness, as determined by the IRC and investigator.
    Measure:Time to Macrovascular Invasion (MVI)
    Time Frame:Ranodimzation to first evidence of MVI (up to approximately 48 months )
    Safety Issue:
    Description:Time to MVI is defined as the time from randomization to the first evidence of MVI, as determined by the IRC and investigator.
    Measure:Time to Extrahepatic Spread (EHS)
    Time Frame:Randomization to first evidence of EHS (up to approximately 48 months)
    Safety Issue:
    Description:Time to EHS is defined as the time from randomization to the first evidence of EHS, as determined by the IRC and investigator.
    Measure:Time to MVI/EHS
    Time Frame:Randomization to first evidence of MVI/EHS (up to approximately 48 months)
    Safety Issue:
    Description:Time to MVI/EHS is defined as the time from randomization to the first evidence of MVI/EHS (whichever occurs first), as determined by the IRC and investigator.
    Measure:Objective Response Rate (ORR)
    Time Frame:Randomization up to approximately 72 months
    Safety Issue:
    Description:Objective response rate (ORR) is defined as the percentage of participants who have a complete or partial response, as determined by the IRC and investigator.
    Measure:Duration of Responses (DOR)
    Time Frame:First occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first)(up to approximately 72 months)
    Safety Issue:
    Description:Duration of responses (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 the IRC and investigator.
    Measure:Time to Deterioration (TTD)
    Time Frame:Randomization to first deterioration (up to approximately 72 months)
    Safety Issue:
    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.
    Measure:Percentage of Participants With Adverse Events
    Time Frame:Baseline up to apporximately 72 months
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Hoffmann-La Roche

    Last Updated

    August 27, 2021