A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma
This is a randomized, double-blind, placebo-controlled, multicenter, 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
724
Durvalumab IV (intravenous)
Bevacizumab IV (intravenous)
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)
Progression Free Survival (PFS) for Arm B vs Arm C
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
Time frame: Approximately 5 years
Progression Free Survival (PFS) for Arm A vs Arm C
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
Time frame: Approximately 5 years
Overall Survival (OS)
OS is defined as the time from the date of randomization until death due to any cause
Time frame: Approximately 5 years
Health status/quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30)
Collection of patient reported outcome (PRO) measures to assess time to deterioration in global health status/quality of life (QoL), functioning (physical) and symptoms
Time frame: Approximately 5 years
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)
Collection of patient reported outcome (PRO) measures to assess time to deterioration in symptoms
Time frame: Approximately 5 years
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TACE (chemo and embolic agent injection into the hepatic artery)
Research Site
Costa Mesa, California, United States
Research Site
La Jolla, California, United States
Research Site
Orange, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Chicago, Illinois, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Detroit, Michigan, United States
...and 156 more locations