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Monoclonal Antibodies

TACE + Durvalumab + Bevacizumab for Liver Cancer (EMERALD-1 Trial)

Phase 3

Waitlist Available

Led By Bruno Sangro, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE

Child-Pugh score class A to B7 and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment

Must not have

Any history of nephrotic or nephritic syndrome

Clinically significant cardiovascular disease or history of arterioembolic event including a stroke or myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

Pivotal Trial

Summary

This trial will test TACE + durvalumab/bevacizumab to see if it's effective against locoregional HCC.

Who is the study for?

This trial is for adults with hepatocellular carcinoma (a type of liver cancer) that hasn't spread outside the liver and can't be treated with surgery or transplantation. Participants should have a certain level of liver function (Child-Pugh score class A to B7), an ECOG performance status of 0 or 1, and no recent significant cardiovascular issues, GI perforations, bleeding disorders, or major surgeries.

What is being tested?

The study tests if combining TACE—a procedure blocking blood flow to parts of the liver—with Durvalumab and Bevacizumab drugs improves outcomes in patients with localized liver cancer. Some participants will receive a placebo instead of these drugs as part of the study's comparison.

What are the potential side effects?

Possible side effects include immune-related reactions due to Durvalumab, high blood pressure from Bevacizumab, and typical chemotherapy effects like fatigue, nausea, decreased appetite. There may also be risks associated with TACE such as abdominal pain and fever.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition cannot be cured with surgery or transplantation, but can be treated with TACE.

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My liver function is moderately impaired, and I can care for myself but not do heavy physical work.

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My cancer has not spread outside my liver.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of kidney disorders.

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I haven't had a heart attack, stroke, or severe heart issues in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

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) for Arm B vs Arm C

Secondary study objectives

Disease-related symptoms measured by European Organization for Research and Treatment of Cancer (EORTC) 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18)

Health status/quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30)

Overall Survival (OS)

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