Description:
A global study to evaluate transarterial chemoembolization (TACE) in combination with
durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma
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 (EMERALD-1)
Clinical Trial IDs
- ORG STUDY ID:
D933GC00001
- SECONDARY ID:
2018-002134-20
- NCT ID:
NCT03778957
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Durvalumab | MEDI4736 | Arm A |
Bevacizumab | AVASTIN | Arm 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, 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
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A | Experimental | Transarterial Chemoembolization (TACE) in combination with Durvalumab | |
Arm B | Experimental | Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab | |
Arm C | Placebo Comparator | Transarterial Chemoembolization (TACE) in combination with Placebos | |
Eligibility Criteria
Key Inclusion Criteria:
- No evidence of extrahepatic disease
- 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, unstable angina, cerebrovascular
accident, or transient ischemic attack within 6 months prior to randomization
- Any prior or current evidence of coagulopathy or bleeding diathesis or patients who
had any kind of surgery in the past 28 days (biopsies are exempt from this exclusion)
- 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: | 110 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary 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 |
Secondary 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 |
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-C30) |
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
August 17, 2021