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Hepatocellular CarcinomaPhase 3EMERALD-1NCT03778957

A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma

A Phase 3 study testing Durvalumab, Bevacizumab and Transarterial Chemoembolization (TACE) in people with Hepatocellular Carcinoma, run by AstraZeneca at 166 sites in 18 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma Read more about this study

Who is it for?
Ages 18 to 110 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Durvalumab, Bevacizumab and Transarterial Chemoembolization (TACE)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
724 participants
Where
166 sitesin 18 countries
Study dates
30 Nov 2018to 31 Aug 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 to B7 and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
  • Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
  • Adequate organ and marrow function

Who cannot join

  • 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
  • Any prior or current evidence of coagulopathy or bleeding diathesis or patients who had any kind of surgery in the past 28 days (biopsies are exempt from this exclusion)
  • History of abdominal fistula or GI perforation, non healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
  • Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded

Trial locations and contacts

166 sites in 18 countries.

166 sites in 18 countries

China30 sites

  • Research Site

    Beijing, 100021

  • Research Site

    Beijing, 100036

  • Research Site

    Beijing, 100069

  • Research Site

    Beijing, 100730

  • Research Site

    Changchun, 130021

  • Research Site

    Changsha, 410013

  • Research Site

    Chengdu, 610041

  • Research Site

    Fuzhou, 350005

  • Research Site

    Fuzhou, 350025

  • Research Site

    Guangzhou, 510060

  • Research Site

    Guangzhou, 510080

  • Research Site

    Guangzhou, 510515

  • Research Site

    Hangzhou, 310022

  • Research Site

    Harbin, 150081

  • Research Site

    Hefei, 230001

  • Research Site

    Nanchang, 330006

  • Research Site

    Nanjing, 210002

  • Research Site

    Nanjing, 210009

  • Research Site

    Nantong, 226361

  • Research Site

    Neijiang, 641100

  • Research Site

    Shanghai, 200032

  • Research Site

    Shanghai, 201508

  • Research Site

    Shenyang, 110001

  • Research Site

    Shenzhen, 518053

  • Research Site

    Tianjin, 300170

  • Research Site

    Wuhan, 430010

  • Research Site

    Wuhan, 430079

  • Research Site

    Xi'an, 710061

  • Research Site

    Zhengzhou, 450008

  • Research Site

    Zhuhai, 519000

Other trials in China

United States24 sites

  • Research Site

    Charlotte, North Carolina, 28204

  • Research Site

    Chicago, Illinois, 60612

  • Research Site

    Cleveland, Ohio, 44106

  • Research Site

    Costa Mesa, California, 92627

  • Research Site

    Dallas, Texas, 75216

  • Research Site

    Dallas, Texas, 75235

  • Research Site

    Detroit, Michigan, 48201

  • Research Site

    Honolulu, Hawaii, 96819

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Houston, Texas, 77090

  • Research Site

    Jacksonville, Florida, 32224

  • Research Site

    La Jolla, California, 92093-0698

  • Research Site

    Memphis, Tennessee, 38104

  • Research Site

    Miami, Florida, 33136

  • Research Site

    Milwaukee, Wisconsin, 53226

  • Research Site

    Orange, California, 92868

  • Research Site

    Pittsburgh, Pennsylvania, 15212

  • Research Site

    Portland, Oregon, 97213

  • Research Site

    Rochester, Minnesota, 55905-0001

  • Research Site

    Shreveport, Louisiana, 71103

  • Research Site

    Sioux Falls, South Dakota, 57105

  • Research Site

    St Louis, Missouri, 63110

  • Research Site

    Stony Brook, New York, 11794

  • Research Site

    Washington D.C., District of Columbia, 20007

Other trials in United States

Japan16 sites

  • Research Site

    Bunkyō City, 113-8655

  • Research Site

    Chiba, 260-8677

  • Research Site

    Chūōku, 104-0045

  • Research Site

    Fukuoka, 810-8563

  • Research Site

    Hiroshima, 734-8551

  • Research Site

    Kurume-shi, 830-0011

  • Research Site

    Musashino-shi, 180-8610

  • Research Site

    Nagoya, 464-8681

  • Research Site

    Okayama, 700-8558

  • Research Site

    Osaka, 534-0021

  • Research Site

    Osaka, 545-8586

  • Research Site

    Osakasayama-shi, 589-8511

  • Research Site

    Sapporo, 006-8555

  • Research Site

    Shiwa-gun, 028-3695

  • Research Site

    Tsu, 514-8507

  • Research Site

    Yokohama, 241-8515

Other trials in Japan

India12 sites

  • Research Site

    Bangalore, 560068

  • Research Site

    Bengaluru, 560076

  • Research Site

    Hyderabad, 500004

  • Research Site

    Kolkata, 700054

  • Research Site

    Kolkata, 700160

  • Research Site

    Madurai, 625107

  • Research Site

    Mumbai, 400 012

  • Research Site

    Nashik, 422002

  • Research Site

    Pune, 411004

  • Research Site

    Surat, 395002

  • Research Site

    Vijayawada, 520002

  • Research Site

    Visakhapatnam, 530017

Other trials in India

Brazil10 sites

  • Research Site

    Barretos, 14784-400

  • Research Site

    Florianópolis, 88034-000

  • Research Site

    Porto Alegre, 90020-090

  • Research Site

    Porto Alegre, 90035-003

  • Research Site

    Porto Alegre, 91350-200

  • Research Site

    Rio de Janeiro, 20231-050

  • Research Site

    Santa Maria, 97015-450

  • Research Site

    São José do Rio Preto, 15090-000

  • Research Site

    São Paulo, 01323-903

  • Research Site

    Vitória, 29043-272

Other trials in Brazil

France9 sites

  • Research Site

    Bobigny, 93000

  • Research Site

    Clichy, 92210

  • Research Site

    Grenoble, 38043

  • Research Site

    Montpellier, 34295

  • Research Site

    Nice, 06202

  • Research Site

    Paris, 75651

  • Research Site

    Pessac, 33604

  • Research Site

    Toulouse, 31059

  • Research Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Mexico8 sites

  • Research Site

    Alc. Cuauhtémoc, 06100

  • Research Site

    Culiacán, 80230

  • Research Site

    Guadalajara, 44280

  • Research Site

    Mérida, 97134

  • Research Site

    México, 14080

  • Research Site

    Monterrey, 64460

  • Research Site

    Monterrey, 64710

  • Research Site

    Tuxtla Gutiérrez, 29090

Other trials in Mexico

Taiwan8 sites

  • Research Site

    Kaohsiung City, 833

  • Research Site

    Liou Ying Township, 736

  • Research Site

    Taichung, 404

  • Research Site

    Taichung, 40705

  • Research Site

    Tainan, 704

  • Research Site

    Taipei, 10002

  • Research Site

    Taipei, 11217

  • Research Site

    Taoyuan City, 333

Other trials in Taiwan

Australia7 sites

  • Research Site

    Benowa, 4217

  • Research Site

    Box Hill, 3128

  • Research Site

    Camperdown, 2050

  • Research Site

    Clayton, 3168

  • Research Site

    Herston, 4029

  • Research Site

    Liverpool, 2170

  • Research Site

    Melbourne, 3004

Other trials in Australia

Russia7 sites

  • Research Site

    Barnaul, 656049

  • Research Site

    Kazan', 420029

  • Research Site

    Moscow, 115478

  • Research Site

    Novosibirsk, 630007

  • Research Site

    Obninsk, 249031

  • Research Site

    Saint Petersburg, 197758

  • Research Site

    Yekaterinburg, 620905

Other trials in Russia

South Korea7 sites

  • Research Site

    Busan, 49241

  • Research Site

    Daegu, 41944

  • Research Site

    Goyang-si, 10408

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 03722

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 06351

Other trials in South Korea

Thailand7 sites

  • Research Site

    Bangkok, 10210

  • Research Site

    Bangkok, 10300

  • Research Site

    Bangkok, 10400

  • Research Site

    Chiang Mai, 50200

  • Research Site

    Hat Yai, 90110

  • Research Site

    Khon Kaen, 40002

  • Research Site

    Phisanulok, 65000

Other trials in Thailand

Canada5 sites

  • Research Site

    Montreal, Quebec, H2X 3E4

  • Research Site

    Montreal, Quebec, H4A 3J1

  • Research Site

    Ottawa, Ontario, K1H 8L6

  • Research Site

    Toronto, Ontario, M4N 3M5

  • Research Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Italy5 sites

  • Research Site

    Arezzo, 52100

  • Research Site

    Brescia, 25100

  • Research Site

    Milan, 20132

  • Research Site

    Milan, 20133

  • Research Site

    Pisa, 56124

Other trials in Italy

Spain4 sites

  • Research Site

    Córdoba, 14004

  • Research Site

    Madrid, 28007

  • Research Site

    Pamplona, 31008

  • Research Site

    San Sebastián(Guipuzcoa), 20014

Other trials in Spain

Vietnam4 sites

  • Research Site

    Hanoi, 100000

  • Research Site

    Hanoi, 123

  • Research Site

    Ho Chi Minh City, 700000

  • Research Site

    Ho Chi Minh City, 70000

Other trials in Vietnam

Hong Kong2 sites

  • Research Site

    Hong Kong, 999077

  • Research Site

    Shatin, 00000

Other trials in Hong Kong

Singapore1 site

  • Research Site

    Singapore, 168583

Other trials in Singapore

About this study

Official title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination With Either Durvalumab Monotherapy or Durvalumab Plus Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1)

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma

Read the detailed description

This is a randomized, double-blind, placebo-controlled, multicenter, global Phase III study to determine the efficacy and safety of transarterial chemoembolization (TACE) treatment in combination with durvalumab monotherapy or TACE given with durvalumab plus bevacizumab therapy compared to TACE therapy alone in patients with locoregional hepatocellular carcinoma not amenable to curative therapy

Being tested
Durvalumab, Bevacizumab, Placebo, Transarterial Chemoembolization (TACE)
Keywords
Hepatocellular Carcinoma, TACE, Durvalumab, Bevacizumab, Liver Cancer
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabDrug

    Also called MEDI4736

    Durvalumab IV (intravenous)

  • BevacizumabDrug

    Also called AVASTIN

    Bevacizumab IV (intravenous)

  • PlaceboOther

    Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)

  • Transarterial Chemoembolization (TACE)Procedure or surgery

    TACE (chemo and embolic agent injection into the hepatic artery)

Study groups in NCT03778957
Study groupRoleWhat they receive
Arm AExperimentalTransarterial Chemoembolization (TACE) in combination with Durvalumab
Receives: Drug: Durvalumab; Other: Placebo; Procedure: Transarterial Chemoembolization (TACE)
Arm BExperimentalTransarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
Receives: Drug: Durvalumab; Drug: Bevacizumab; Procedure: Transarterial Chemoembolization (TACE)
Arm CPlacebo comparatorTransarterial Chemoembolization (TACE) in combination with Placebos
Receives: Other: Placebo; Procedure: Transarterial Chemoembolization (TACE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) for Arm B vs Arm C

    PFS per Blinded Independent Central Review (BICR) assessment will be defined as the time from the date of randomization until the date of first objective disease progression or death

    Measured: Approximately 5 years

Secondary outcomes (4)

  1. Progression Free Survival (PFS) for Arm A vs Arm C

    PFS per Blinded Independent Central Review (BICR) assessment will be defined as the time from the date of randomization until the date of first objective disease progression or death

    Measured: Approximately 5 years

  2. Overall Survival (OS)

    OS is defined as the time from the date of randomization until death due to any cause

    Measured: Approximately 5 years

  3. 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)

    Collection of patient reported outcome (PRO) measures to assess time to deterioration in global health status/quality of life (QoL), functioning (physical) and symptoms

    Measured: Approximately 5 years

  4. 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)

    Collection of patient reported outcome (PRO) measures to assess time to deterioration in symptoms

    Measured: Approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2018
  2. Study start30 Nov 2018
  3. Primary completion11 Sep 2023
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
724 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03778957
Sponsor's protocol ID
D933GC00001
Other IDs
2023-509053-32-00, 2018-002134-20, 2018, 2023
Acronym
EMERALD-1
Status last verified
Jul 2026
First submitted
28 Nov 2018
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Publications

  • Sangro B, Kudo M, Erinjeri JP, Qin S, Ren Z, Chan SL, Arai Y, Heo J, Mai A, Escobar J, Lopez Chuken YA, Yoon JH, Tak WY, Breder VV, Suttichaimongkol T, Bouattour M, Lin SM, Peron JM, Nguyen QT, Yan L, Chiu CF, Santos FA, Veluvolu A, Thungappa SC, Matos M, Zotkiewicz M, Udoye SI, Kurland JF, Cohen GJ, Lencioni R; EMERALD-1 Investigators. Durvalumab with or without bevacizumab with transarterial chemoembolisation in hepatocellular carcinoma (EMERALD-1): a multiregional, randomised, double-blind, placebo-controlled, phase 3 study. Lancet. 2025 Jan 18;405(10474):216-232. doi: 10.1016/S0140-6736(24)02551-0. Epub 2025 Jan 8.

    PubMed 39798579

  • Kloeckner R, Galle PR, Bruix J. Local and Regional Therapies for Hepatocellular Carcinoma. Hepatology. 2021 Jan;73 Suppl 1:137-149. doi: 10.1002/hep.31424. Epub 2020 Nov 6. No abstract available.

    PubMed 32557715

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Durvalumab, Bevacizumab and Transarterial Chemoembolization (TACE) in people with Hepatocellular Carcinoma, run by AstraZeneca at 166 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in China, United States, Japan, India, Brazil and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) for Arm B vs Arm C (time frame: Approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03778957, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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