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Checkpoint Inhibitor

Immunotherapy + TACE +/- Lenvatinib for Liver Cancer (EMERALD-3 Trial)

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No evidence of extrahepatic disease
Child Pugh score class A
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights

EMERALD-3 Trial Summary

This trial will test a new combination therapy for liver cancer.

Who is the study for?
This trial is for adults with hepatocellular carcinoma (a type of liver cancer) that can't be removed by surgery but can be treated with TACE. Participants should have no cancer outside the liver, an ECOG performance status of 0 or 1 indicating they are fully active or restricted in physically strenuous activity only, and a Child Pugh score class A showing mild liver disease.Check my eligibility
What is being tested?
The study tests if combining TACE with durvalumab and tremelimumab, with or without lenvatinib, improves outcomes in patients with locoregional HCC. It's a global study assessing the effectiveness and safety of these therapies when used together.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs like the lungs or intestines, fatigue, skin rash, nausea, high blood pressure from lenvatinib; plus typical TACE side effects such as fever, abdominal pain, and loss of appetite.

EMERALD-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has not spread outside my liver.
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My liver function is good.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My condition cannot be cured with surgery or transplantation, but can be treated with TACE.

EMERALD-3 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS) for Arm A vs Arm C
Secondary outcome measures
Overall Survival (OS) for Arm A vs Arm C
Overall Survival (OS) for Arm B vs Arm C
Progression Free Survival (PFS) for Arm B vs Arm C

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

EMERALD-3 Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm BExperimental Treatment3 Interventions
Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)
Group II: Arm AExperimental Treatment4 Interventions
Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
Group III: Arm CActive Control1 Intervention
Transarterial Chemoembolization (TACE)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
2017
Completed Phase 2
~3380
Durvalumab
2017
Completed Phase 2
~3870
Lenvatinib
2005
Completed Phase 4
~2690

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,177 Total Patients Enrolled
2 Trials studying Liver Cancer
1,040 Patients Enrolled for Liver Cancer

Media Library

Durvalumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05301842 — Phase 3
Liver Cancer Research Study Groups: Arm A, Arm B, Arm C
Liver Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT05301842 — Phase 3
Durvalumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05301842 — Phase 3

Frequently Asked Questions

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

Does this test include people who are not yet 60 years old?

"Eligibility for this clinical trial includes patients between 18 and 120 years old. There are 84 trials for minors and 2654 for senior citizens."

Answered by AI

What is the official verdict from the FDA on Durvalumab?

"There is a solid body of evidence, from both Phase 3 clinical trials and additional research, suggesting that Durvalumab is a safe medication."

Answered by AI

Who does this research project target as test subjects?

"This study is looking for 525 participants that have liver carcinoma, are between 18 and 120 years old, and also meet the following requirements: no evidence of extrahepatic disease, disease not curable through surgery or transplant but treatable through TACE, Child Pugh score of A, ECOG performance status of 0 or 1, measurable disease by mRECIST criteria, and adequate organ and marrow function."

Answered by AI

Does this experiment still require more participants?

"That is accurate, the information available on clinicaltrials.gov does show that this study is still recruiting patients. This particular trial was first made public on March 28th, 2022 and the most recent update was on September 27th, 2022. In total, they are looking for 525 individuals to participate across 10 different sites."

Answered by AI

How many people are participating in this test to find out if the new medication is effective?

"Yes, the information on clinicaltrials.gov indicates that this clinical trial is currently seeking candidates. The trial was initially posted on 3/28/2022 and was last updated on 9/27/2022. The study is recruiting for 525 patients at 10 locations."

Answered by AI

Yes, the clinical trial is being run at multiple locations in Canada.

"To minimize participant burden, the team running this study has chosen to set up shop in 10 locations spread out over Baltimore, Montreal, Ottawa, and 10 other cities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC
2022. "Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05301842.
~322 spots leftby Dec 2025
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