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

Part of paid clinical trials in Costa Mesa, California.

Sponsor
AstraZeneca
Study ID
NCT03778957
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 110 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab IV (intravenous)
  • Bevacizumab — DRUG
    Bevacizumab IV (intravenous)
  • Placebo — OTHER
    Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)
  • Transarterial Chemoembolization (TACE) — PROCEDURE
    TACE (chemo and embolic agent injection into the hepatic artery)

Study Details

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

Key Dates

Start date
Nov 30, 2018
Status verified
Apr 2026
Primary completion
Sep 11, 2023
Completion
Aug 31, 2026

Study Design

Enrollment
724 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Transarterial Chemoembolization (TACE) in combination with Durvalumab
  • Experimental: Arm B
    Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
  • Placebo Comparator: Arm C
    Transarterial Chemoembolization (TACE) in combination with Placebos

Primary Outcome Measure

Progression Free Survival (PFS) for Arm B vs Arm C [ Time Frame: Approximately 5 years ]

Locations (24)

FacilityCityStateZIPSite coordinators
Research SiteCosta MesaCalifornia92627-
Research SiteLa JollaCalifornia92093-0698-
Research SiteOrangeCalifornia92868-
Research SiteWashington D.C.District of Columbia20007-
Research SiteJacksonvilleFlorida32224-
Research SiteMiamiFlorida33136-
Research SiteHonoluluHawaii96819-
Research SiteChicagoIllinois60612-
Research SiteShreveportLouisiana71103-
Research SiteDetroitMichigan48201-
Research SiteRochesterMinnesota55905-0001-
Research SiteSt LouisMissouri63110-
Research SiteStony BrookNew York11794-
Research SiteCharlotteNorth Carolina28204-
Research SiteClevelandOhio44106-
Research SitePortlandOregon97213-
Research SitePittsburghPennsylvania15212-
Research SiteSioux FallsSouth Dakota57105-
Research SiteMemphisTennessee38104-
Research SiteDallasTexas75216-
Research SiteDallasTexas75235-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77090-
Research SiteMilwaukeeWisconsin53226-

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