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Monoclonal Antibodies
TARE + Durvalumab + Bevacizumab for Liver Cancer (EMERALD-Y90 Trial)
Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from first documented response until documented progression (approximately 3 years)
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see how well a combination of durvalumab and bevacizumab given through an IV works in participants with liver cancer that cannot be removed through surgery, and who have
Who is the study for?
This trial is for adults with unresectable liver cancer (HCC) who can undergo TARE, have a Child-Pugh score class A (indicating good liver function), no cancer outside the liver, at least one measurable tumor in the liver, and are generally in good health or only mildly ill. They must also meet specific criteria for lung safety during treatment and have enough healthy liver tissue.
What is being tested?
The study tests if combining Durvalumab (an IV drug) and Bevacizumab (another IV drug) after Transarterial Radioembolization (TARE using Yttrium 90 microspheres) improves outcomes for patients with HCC that cannot be surgically removed. The effectiveness and safety of this combination therapy are being evaluated.
What are the potential side effects?
Potential side effects include those related to Durvalumab such as immune-related reactions affecting various organs, infusion reactions, fatigue; Bevacizumab may cause bleeding, high blood pressure; TARE could lead to abdominal pain or fever post-procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from first documented response until documented progression (approximately 3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from first documented response until documented progression (approximately 3 years)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Duration of Response (DoR)
Number of participants with Adverse events (AEs)
Objective Response Rate (ORR)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Yttrium 90 glass microspheres TARE in combination with Durvalumab and BevacizumabExperimental Treatment3 Interventions
Participants will undergo Yttrium 90 glass microspheres TARE according to the dosimetry recommendation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3750
Bevacizumab
2013
Completed Phase 4
~5540
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,511 Total Patients Enrolled
1 Trials studying Liver Cancer
40 Patients Enrolled for Liver Cancer