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Monoclonal Antibodies

Yttrium 90 glass microspheres TARE in combination with Durvalumab and 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

EMERALD-Y90 Trial 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.Check my eligibility

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.See study design

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.

EMERALD-Y90 Trial 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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first documented response until documented progression (approximately 3 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS)

Secondary outcome measures

Duration of Response (DoR)

Number of participants with Adverse events (AEs)

Objective Response Rate (ORR)

+1 more

EMERALD-Y90 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

~3870

Bevacizumab

2013

Completed Phase 4

~5280

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,272 Previous Clinical Trials

288,612,575 Total Patients Enrolled

2 Trials studying Liver Cancer

1,040 Patients Enrolled for Liver Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being admitted into this research trial?

"Indeed, the information available on clinicaltrials.gov indicates that this research is actively enrolling subjects. The trial was initially posted on February 13th, 2024 and last revised on March 6th of the same year. Recruitment aims to include a total of 100 participants from twelve different sites."

Answered by AI

Can participants aged 75 years and older be considered for inclusion in this study?

"To be eligible for this research study, participants must be at least 18 years old and no more than 130 years old."

Answered by AI

Is the enrollment process currently open for this clinical trial?

"Affirmative. The information on clinicaltrials.gov indicates that this current trial is actively seeking participants. It was first listed on February 13, 2024, with the latest update on March 6, 2024. This study aims to enroll a total of 100 individuals across a dozen sites."

Answered by AI

At how many distinct sites is this clinical trial being conducted?

"At the moment, enrollment is ongoing at 12 different research facilities. These sites are located in Aurora, Buffalo, Rochester, and a dozen more cities. Opting for the nearest site can lessen travel burdens once enrolled."

Answered by AI

Is it possible for me to enroll as a participant in this research study?

"This study aims to enroll 100 individuals aged between 18 and 130 with liver cancer. Noteworthy requirements include: maintaining Lung dose threshold for Yttrium 90 glass microspheres at or below 30 Gy per treatment, ensuring the Future Liver Remnant Volume (FLRV) is equal to or greater than 30% of total liver volume, having a Child-Pugh score class A, absence of extrahepatic disease on imaging studies, presence of one or more measurable lesions, unilobar disease in cases involving segmental or right anterior/posterior portal vein invasion (Vp1/Vp2) suitable for"

Answered by AI

Has the FDA sanctioned the usage of Yttrium 90 glass microspheres TARE alongside Durvalumab and Bevacizumab?

"Based on our assessment, the safety rating for utilizing Yttrium 90 glass microspheres TARE alongside Durvalumab and Bevacizumab is a 2. This evaluation stems from the fact that while there are some indications of its safety profile in this Phase 2 trial, data supporting efficacy remains lacking at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE

2024. "A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06040099.

All > Hcc > Hepatocellular Carcinoma