Suspended

EMERALD-3A Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination With Tremelimumab ± Lenvatinib Given Concurrently With TACE Compared to TACE Alone in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-3)

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What is being tested

Tremelimumab

+ Durvalumab

+ Transarterial Chemoembolization (TACE)

DrugProcedure
Who is being recruted

Adenocarcinoma+8

+ Carcinoma

+ Digestive System Diseases

From 18 to 120 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 2022
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 28, 2022

Actual date on which the first participant was enrolled.

This is a Phase III, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, international study assessing the efficacy and safety of durvalumab + tremelimumab + TACE with or without lenvatinib compared with TACE alone in participants with locoregional HCC not amenable to curative therapy (eg, surgical resection, transplantation, or ablation).

Official TitleA Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination With Tremelimumab ± Lenvatinib Given Concurrently With TACE Compared to TACE Alone in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-3)
NCT05301842
Principal SponsorAstraZeneca
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

760 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsCarcinoma, HepatocellularLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and Epithelial

Criteria

6 inclusion criteria required to participate
No evidence of extrahepatic disease
Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE
Child Pugh score class A
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
Show More Criteria
5 exclusion criteria prevent from participating
History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardia arrhythmia
History of hepatic encephalopathy
Major portal vein thrombosis visible on baseline imaging
Uncontrolled arterial hypertension
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)

Group II

Experimental
Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)

Group III

Active Comparator
Transarterial Chemoembolization (TACE)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 171 locations

Suspended

Research Site

Birmingham, United StatesOpen Research Site in Google Maps
Suspended

Research Site

Mobile, United States
Suspended

Research Site

Yuma, United States
Suspended

Research Site

Glendale, United States
Suspended171 Study Centers