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Monoclonal Antibodies
TACE + Durvalumab + Bevacizumab for Liver Cancer (EMERALD-1 Trial)
Phase 3
Waitlist Available
Led By Riccardo Lencioni, MD FSIR EBIR
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights
EMERALD-1 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.Check my eligibility
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.See study design
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.
EMERALD-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition cannot be cured with surgery or transplantation, but can be treated with TACE.
Select...
My liver function is moderately impaired, and I can care for myself but not do heavy physical work.
Select...
My cancer has not spread outside my liver.
EMERALD-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
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) for Arm B vs Arm C
Secondary outcome measures
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)
+1 moreOther outcome measures
Immunogenicity of Durvalumab and Bevacizumab as measured by presence of anti-drug antibodies (ADAs)
Pharmacokinetics (PK) of Durvalumab and Bevacizumab as determined by peak serum concentrations
Safety of Durvalumab and Bevacizumab as evaluated by summary of adverse events by treatment arm and CTCAE grade
EMERALD-1 Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm BExperimental Treatment3 Interventions
Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
Group II: Arm AExperimental Treatment3 Interventions
Transarterial Chemoembolization (TACE) in combination with Durvalumab
Group III: Arm CPlacebo Group2 Interventions
Transarterial Chemoembolization (TACE) in combination with Placebos
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
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,265 Previous Clinical Trials
288,604,558 Total Patients Enrolled
2 Trials studying Liver Cancer
1,040 Patients Enrolled for Liver Cancer
Riccardo Lencioni, MD FSIR EBIRPrincipal InvestigatorUniversity of Pisa / Miami Cancer Institute
Bruno Sangro, MDPrincipal InvestigatorClinica Universidad de Navarra
3 Previous Clinical Trials
79 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of kidney disorders.My organs and bone marrow are working well.My condition cannot be cured with surgery or transplantation, but can be treated with TACE.I haven't had surgery in the last 28 days and don't have bleeding disorders.My liver function is moderately impaired, and I can care for myself but not do heavy physical work.I haven't had stomach or intestine issues like fistulas, unhealed ulcers, or bleeding in the last 6 months.I haven't had a heart attack, stroke, or severe heart issues in the last 6 months.My cancer has not spread outside my liver.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
- Group 3: Arm C
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
has the FDA cleared Transarterial Chemoembolization (TACE) for use?
"TACE has received a safety score of 3."
Answered by AI
What conditions has Transarterial Chemoembolization (TACE) been demonstrated to be effective for?
"Patients with recurrent platinum drug resistant primary peritoneal cancer, who have not received prior treatment and are eligible for Transarterial Chemoembolization (TACE), can be considered for this study."
Answered by AI
Are elderly patients welcome in this experiment?
"The age requirements to participate in this trial are that individuals must be at least 18 years old, and cannot be older than 110."
Answered by AI
If I qualify, may I take part in this research project?
"724 individuals aged 18-110 who have carcinoma are able to participate in this clinical trial. In order for patients to be eligible, they must meet the following conditions: their disease cannot be cured surgically or through transplantation/ablation, and it must be possible to treat with TACE; in addition, patients must have a Child-Pugh score of A or B7, an ECOG performance status of 0 or 1, and measurable disease by mRECIST criteria. Finally, participants must have adequate organ and marrow function."
Answered by AI
Are there other ongoing research projects that use Transarterial Chemoembolization (TACE)?
"There are presently 701 active clinical trials for Transarterial Chemoembolization (TACE), with 147 in Phase 3. The majority of these TACE studies are based out of New york City, although there are 30979 total locations running TACE trials."
Answered by AI
Are there any current vacancies for this clinical trial?
"The most recent information available on clinicaltrials.gov suggests that this particular study is no longer recruiting patients. Although, there are over 3000 other trials that are currently searching for candidates to participate."
Answered by AI
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