Hepatocellular Carcinoma (HCC)Phase 2EMERALD-Y90NCT06040099
A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE
A Phase 2 study testing Durvalumab, Bevacizumab and Transarterial Radioembolization (TARE) in people with Hepatocellular Carcinoma (HCC), run by AstraZeneca at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Durvalumab, Bevacizumab and Transarterial Radioembolization (TARE)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 21 sitesUnited States
- Study dates
- 13 Feb 2024to 27 May 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Atlanta, Georgia, 30342
Research Site
Aurora, Colorado, 80045
Research Site
Boston, Massachusetts, 02118
Research Site
Buffalo, New York, 14263
Research Site
Chapel Hill, North Carolina, 27599
Research Site
Charlottesville, Virginia, 22908
Research Site
Chicago, Illinois, 60611
Research Site
Columbus, Ohio, 43210
Research Site
Detroit, Michigan, 48201
Research Site
Gainesville, Florida, 32608
Research Site
Houston, Texas, 77030
Research Site
Milwaukee, Wisconsin, 53215
Research Site
Milwaukee, Wisconsin, 53226
Research Site
New York, New York, 10029
Research Site
Orlando, Florida, 32804
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Portland, Oregon, 97239
Research Site
Seattle, Washington, 98195
Research Site
St Louis, Missouri, 63110
Research Site
Trenton, New Jersey, 08690
About this study
Official title: 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
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.
Read the detailed description
A Phase II single-arm study conducted in participants with unresectable Hepatocellular carcinoma (HCC) eligible for embolization and not eligible for or who have declined treatment with resection and/or ablation or liver transplant.
Participants with previous Transarterial Chemoembolization (TACE) or TARE associated with the curative setting are permitted with a 6-month washout.
Approximately 120 participants with unresectable but amenable to locoregional therapy HCC eligible for embolization will be screened in the study at approximately 20 sites in the US to enroll approximately 60 participants.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Durvalumab, Bevacizumab, Transarterial Radioembolization (TARE)
- Keywords
- TARE, Durvalumab, Bevacizumab, Liver Cancer, Y90
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736, IMFINZI
Durvalumab IV (intravenous)
BevacizumabDrug
Also called AVASTIN, ZIRABEV
Bevacizumab IV (intravenous)
Transarterial Radioembolization (TARE)Procedure or surgery
Also called TheraSphere
Yttrium 90 glass microspheres will be administered
| Study group | Role | What they receive |
|---|---|---|
| Yttrium 90 glass microspheres TARE in combination with Durvalumab and Bevacizumab | Experimental | Participants will undergo Yttrium 90 glass microspheres TARE according to the dosimetry recommendation. Receives: Drug: Durvalumab; Drug: Bevacizumab; Procedure: Transarterial Radioembolization (TARE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 1 until date of progressive disease or death [Approximately 3 years]
Secondary outcomes (4)
Number of participants with Adverse events (AEs)
To assess the safety of the sequence of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy
Measured: From Screening (Day -28 to Day 1) until 90 days after the last dose of study drug
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a confirmed complete response or partial response, as determined by the investigator per mRECIST. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy.
Measured: From Day 1 until progression, or the last evaluable assessment in the absence of progression (Approximately 3 years)
Overall Survival (OS)
OS is defined as the time from the start of TARE until the date of death due to any cause. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy.
Measured: Day 1 to 18 months or until death (Approximately 3 years)
Duration of Response (DoR)
DoR is defined as the time from the date of first documented response (that is subsequently confirmed) until the date of documented progression per mRECIST as assessed by the investigator, or death due to any cause. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy.
Measured: Time from first documented response until documented progression (Approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start13 Feb 2024
- Primary completion30 Jun 2026
- Study completion27 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040099
- Sponsor's protocol ID
- D933GC00002
- Acronym
- EMERALD-Y90
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41903993