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A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma

NCT03778957

Description:

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
  • Official Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination With Either Durvalumab Monotherapy or Durvalumab Plus Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: D933GC00001
  • SECONDARY ID: 2018-002134-20
  • NCT ID: NCT03778957

Conditions

  • Hepatocellular Carcinoma

Interventions

DrugSynonymsArms
DurvalumabMEDI4736Arm A
BevacizumabAVASTINArm B

Purpose

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma

Detailed Description

      This is a randomized, double-blind, placebo-controlled, multi-center, global Phase III study
      to determine the efficacy and safety of transarterial chemoembolization (TACE) treatment in
      combination with durvalumab monotherapy or TACE given with durvalumab plus bevacizumab
      therapy compared to TACE therapy alone in patients with locoregional hepatocellular carcinoma
      not amenable to curative therapy
    

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalTransarterial Chemoembolization (TACE) in combination with Durvalumab
  • Durvalumab
Arm BExperimentalTransarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
  • Durvalumab
  • Bevacizumab
Arm CPlacebo ComparatorTransarterial Chemoembolization (TACE) in combination with Placebos

    Eligibility Criteria

            Key Inclusion Criteria:
    
              -  No evidence of extrahepatic disease on baseline imaging
    
              -  Disease not amenable to curative surgery or transplantation or curative ablation but
                 disease amenable to TACE
    
              -  Child-Pugh score class A to B7 and Eastern Cooperative Oncology Group (ECOG)
                 performance status of 0 or 1 at enrollment
    
              -  Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
    
              -  Adequate organ and marrow function
    
            Key Exclusion Criteria
    
              -  Any history of nephrotic or nephritic syndrome
    
              -  Clinically significant cardiovascular disease or history of arterioembolic event
                 including a stroke or myocardial infarction
    
              -  Any prior or current evidence of coagulopathy or bleeding diathesis or patients who
                 had any kind of surgery in the past 28 days
    
              -  History of abdominal fistula or GI perforation, non healed gastric ulcer that is
                 refractory to treatment, or active GI bleeding within 6 months prior to enrollment
    
              -  Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Progression Free Survival (PFS) for Arm A vs Arm C
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:PFS per Blinded Independent Central Review (BICR) assessment will be defined as the time from the date of randomization until the date of first objective disease progression or death

    Secondary Outcome Measures

    Measure:Progression Free Survival (PFS) for Arm B vs Arm C
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:PFS per Blinded Independent Central Review (BICR) assessment will be defined as the time from the date of randomization until the date of first objective disease progression or death
    Measure:Overall Survival (OS)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:OS is defined as the time from the date of randomization until death due to any cause
    Measure:Health status/quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-30)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:Collection of patient reported outcome (PRO) measures to assess time to deterioration in global health status/quality of life (QoL), functioning (physical) and symptoms
    Measure:Disease-related symptoms measured by European Organization for Research and Treatment of Cancer (EORTC) 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:Collection of patient reported outcome (PRO) measures to assess time to deterioration in symptoms

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:AstraZeneca

    Trial Keywords

    • Hepatocellular Carcinoma
    • TACE
    • Durvalumab
    • Bevacizumab
    • Liver Cancer

    Last Updated