A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE
EMERALD-Y90
Phase II Single-Arm Study of Durvalumab and Bevacizumab Following Transarterial Radioembolization Using Yttrium-90 Glass Microspheres (TheraSphere™) in Unresectable Hepatocellular Carcinoma Amenable to Locoregional Therapy
1 other identifier
interventional
58
1 country
21
Brief Summary
The purpose of this study is to measure the efficacy and safety of durvalumab intravenous (IV) solution plus bevacizumab IV solution after transarterial radioembolization (Yttrium 90 glass microspheres TARE) in participants with unresectable hepatocellular carcinoma (HCC) amenable to embolization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2024
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2023
CompletedFirst Posted
Study publicly available on registry
September 15, 2023
CompletedStudy Start
First participant enrolled
February 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
March 19, 2026
March 1, 2026
2.4 years
September 11, 2023
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS is defined as the time from Day 1 (day of TARE) until the date of progressive disease per modified Response Evaluation Criteria in Solid Tumors (mRECIST), as assessed by the investigator, or death due to any cause. It is measured to assess the efficacy of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy.
From Day 1 until date of progressive disease or death [Approximately 3 years]
Secondary Outcomes (4)
Number of participants with Adverse events (AEs)
From Screening (Day -28 to Day 1) until 90 days after the last dose of study drug
Objective Response Rate (ORR)
From Day 1 until progression, or the last evaluable assessment in the absence of progression (Approximately 3 years)
Overall Survival (OS)
Day 1 to 18 months or until death (Approximately 3 years)
Duration of Response (DoR)
Time from first documented response until documented progression (Approximately 3 years)
Study Arms (1)
Yttrium 90 glass microspheres TARE in combination with Durvalumab and Bevacizumab
EXPERIMENTALParticipants will undergo Yttrium 90 glass microspheres TARE according to the dosimetry recommendation.
Interventions
Durvalumab IV (intravenous)
Bevacizumab IV (intravenous)
Yttrium 90 glass microspheres will be administered
Eligibility Criteria
You may qualify if:
- Participants with confirmed unresectable HCC
- Participants with Lung dose threshold for Yttrium 90 glass microspheres of 30 Gy (equal or less than 30 Gy per treatment for glass) and an estimated Future liver remnant volume (FLRV) ≥ 30% of whole liver volume.
- Participants with more than 1 prior embolization are permitted if more than 12 months ago, for a different primary lesion, and FLR \> 30%.
- Participants with no evidence of extrahepatic disease on any available imaging
- Participants with one or more measurable lesions, unilobar disease for participants with segmental or right anterior/posterior portal vein invasion (Vp1/Vp2) and eligible for Yttrium 90 glass microspheres TARE.
- Participants having Child-Pugh score class A.
- Participants having ECOG performance status of 0 or 1 at enrollment
- Adequate organ and marrow function
You may not qualify if:
- Disease amenable to curative surgery, ablation or transplantation. Transplant patients are considered eligible if outside of Milan criteria and not currently listed for transplant.
- Participants co-infected with HBV and HDV
- Any history of nephrotic or nephritic syndrome.
- Clinically significant (eg, active) cardiovascular disease
- Participants with uncontrolled hypertension
- History of hepatic encephalopathy
- Known hereditary predisposition to bleeding or thrombosis; any prior or current evidence of bleeding diathesis.
- Receipt of more than 1 prior embolization (TACE or TARE) treatment/procedure
- Participant has received any prior anticancer systemic therapy for unresectable HCC.
- History of arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment.
- History of abdominal fistula or gastrointestinal (GI) perforation, non-healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (21)
Research Site
Aurora, Colorado, 80045, United States
Research Site
Gainesville, Florida, 32608, United States
Research Site
Orlando, Florida, 32804, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
Atlanta, Georgia, 30342, United States
Research Site
Chicago, Illinois, 60611, United States
Research Site
Boston, Massachusetts, 02118, United States
Research Site
Detroit, Michigan, 48201, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
Trenton, New Jersey, 08690, United States
Research Site
Buffalo, New York, 14263, United States
Research Site
New York, New York, 10029, United States
Research Site
Chapel Hill, North Carolina, 27599, United States
Research Site
Columbus, Ohio, 43210, United States
Research Site
Portland, Oregon, 97239, United States
Research Site
Philadelphia, Pennsylvania, 19107, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Charlottesville, Virginia, 22908, United States
Research Site
Seattle, Washington, 98195, United States
Research Site
Milwaukee, Wisconsin, 53215, United States
Research Site
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Pabon CM, Kumar-Sharma P, Spieler BO, Tuerff D, Datta J, Hosein PJ. Identifying Subsets of Patients with Non-immunogenic Gastrointestinal Cancers for Checkpoint Immunotherapy. Surg Oncol Clin N Am. 2026 Apr;35(2):347-365. doi: 10.1016/j.soc.2025.10.008. Epub 2026 Jan 14.
PMID: 41903993DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2023
First Posted
September 15, 2023
Study Start
February 13, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.