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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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)
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
Are there results?
Not yet: the study is under way

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
Show all 11Show fewer
  • 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

Other trials in United States

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.

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 groups in NCT06040099
Study groupRoleWhat they receive
Yttrium 90 glass microspheres TARE in combination with Durvalumab and BevacizumabExperimentalParticipants 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.

  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.

    Measured: From Day 1 until date of progressive disease or death [Approximately 3 years]

Secondary outcomes (4)

  1. 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

  2. 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)

  3. 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)

  4. 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.

  1. First posted15 Sep 2023
  2. Study start13 Feb 2024
  3. Primary completion30 Jun 2026
  4. Study completion27 May 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From Day 1 until date of progressive disease or death [Approximately 3 years]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06040099, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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