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Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment

NCT03847428

Description:

A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT03847428

Trial Eligibility

Document

Title

  • Brief Title: Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
  • Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Clinical Trial IDs

  • ORG STUDY ID: D910DC00001
  • SECONDARY ID: 2018-004105-85
  • NCT ID: NCT03847428

Conditions

  • Hepatocellular Carcinoma

Interventions

DrugSynonymsArms
DurvalumabIMFINZIArm A
BevacizumabAVASTINArm A

Purpose

A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.

Detailed Description

      This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, global study
      to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab
      monotherapy or placebo as adjuvant therapy. This study will be conducted in patients with HCC
      who are at high risk of recurrence after curative hepatic resection or ablation.

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalDurvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W)
  • Durvalumab
  • Bevacizumab
Arm BExperimentalDurvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W)
  • Durvalumab
Arm CPlacebo ComparatorDurvalumab placebo (Q3W) + bevacizumab placebo (Q3W)

    Eligibility Criteria

            Inclusion Criteria:

          -  Histologically or cytologically (or radiologically for patients undergoing curative
             ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy
             (resection or ablation)

          -  Imaging to confirm disease-free status within 28 days prior to randomization

          -  ECOG 0-1 at enrolment

          -  Child-Pugh score of 5 or 6

          -  Adequate organ and marrow function.

        Exclusion Criteria:

          -  Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC

          -  Evidence of metastasis, macrovascular invasion or co-existing malignant disease on
             baseline imaging

          -  History of hepatic encephalopathy within 12 months prior to randomization

          -  Evidence, by Investigator assessment, of varices at risk of bleeding on upper
             endoscopy or contrast-enhanced cross-sectional imaging

          -  Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded

          -  Active co-infection with HBV and HDV.

          -  Receipt of prior systemic anticancer therapy for HCC

          -  Those on a waiting list for liver transplantation
    Maximum Eligible Age:150 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Recurrence-free survival (RFS) for Arm A vs Arm C
    Time Frame:Up to 49 months after first patient randomized
    Safety Issue:
    Description:RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.

    Secondary Outcome Measures

    Measure:Recurrence-free survival (RFS) Arm B vs Arm C
    Time Frame:Up to 49 months after first patient randomized
    Safety Issue:
    Description:RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
    Measure:Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C
    Time Frame:No timeframe
    Safety Issue:
    Description:OS is defined as the time from the date of randomization until death due to any cause
    Measure:Recurrence-free survival at 24 months (RFS24) and 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C
    Time Frame:At 24 and at 36 months
    Safety Issue:
    Description:Proportion of RFS at 24 months and at 36 months
    Measure:Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C
    Time Frame:Up to 49 months after first patient randomized
    Safety Issue:
    Description:TTR is defined as the time from the date of randomization until the date of disease recurrence
    Measure:Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C
    Time Frame:Up to 49 months after first patient randomized
    Safety Issue:
    Description:Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)

    Details

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

    Trial Keywords

    • Early stage HCC
    • Durvalumab
    • Bevacizumab
    • Liver Cancer

    Last Updated

    August 17, 2021