A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
EMERALD-1
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)
3 other identifiers
interventional
724
18 countries
166
Brief Summary
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hepatocellular-carcinoma
Started Nov 2018
Longer than P75 for phase_3 hepatocellular-carcinoma
166 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2018
CompletedStudy Start
First participant enrolled
November 30, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedApril 15, 2026
April 1, 2026
4.8 years
November 28, 2018
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Approximately 5 years
Secondary Outcomes (4)
Progression Free Survival (PFS) for Arm A vs Arm C
Approximately 5 years
Overall Survival (OS)
Approximately 5 years
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)
Approximately 5 years
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)
Approximately 5 years
Other Outcomes (3)
Safety of Durvalumab and Bevacizumab as evaluated by summary of adverse events by treatment arm and CTCAE grade
Approximately 5 years
Immunogenicity of Durvalumab and Bevacizumab as measured by presence of anti-drug antibodies (ADAs)
Approximately 5 years
Pharmacokinetics (PK) of Durvalumab and Bevacizumab as determined by peak serum concentrations
Approximately 5 years
Study Arms (3)
Arm A
EXPERIMENTALTransarterial Chemoembolization (TACE) in combination with Durvalumab
Arm B
EXPERIMENTALTransarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
Arm C
PLACEBO COMPARATORTransarterial Chemoembolization (TACE) in combination with Placebos
Interventions
TACE (chemo and embolic agent injection into the hepatic artery)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (166)
Research Site
Costa Mesa, California, 92627, United States
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La Jolla, California, 92093-0698, United States
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Orange, California, 92868, United States
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Washington D.C., District of Columbia, 20007, United States
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Jacksonville, Florida, 32224, United States
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Miami, Florida, 33136, United States
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Honolulu, Hawaii, 96819, United States
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Chicago, Illinois, 60612, United States
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Shreveport, Louisiana, 71103, United States
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Detroit, Michigan, 48201, United States
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Rochester, Minnesota, 55905-0001, United States
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St Louis, Missouri, 63110, United States
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Stony Brook, New York, 11794, United States
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Charlotte, North Carolina, 28204, United States
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Cleveland, Ohio, 44106, United States
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Portland, Oregon, 97213, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Sioux Falls, South Dakota, 57105, United States
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Memphis, Tennessee, 38104, United States
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Dallas, Texas, 75216, United States
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Dallas, Texas, 75235, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77090, United States
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Milwaukee, Wisconsin, 53226, United States
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Benowa, 4217, Australia
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Box Hill, 3128, Australia
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Camperdown, 2050, Australia
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Clayton, 3168, Australia
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Herston, 4029, Australia
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Liverpool, 2170, Australia
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Melbourne, 3004, Australia
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Barretos, 14784-400, Brazil
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Florianópolis, 88034-000, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90035-003, Brazil
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Porto Alegre, 91350-200, Brazil
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Rio de Janeiro, 20231-050, Brazil
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Santa Maria, 97015-450, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01323-903, Brazil
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Vitória, 29043-272, Brazil
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Beijing, 100021, China
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Beijing, 100036, China
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Beijing, 100069, China
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Beijing, 100730, China
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Changchun, 130021, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Fuzhou, 350005, China
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Fuzhou, 350025, China
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Guangzhou, 510060, China
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Guangzhou, 510080, China
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Guangzhou, 510515, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230001, China
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Nanchang, 330006, China
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Nanjing, 210002, China
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Nanjing, 210009, China
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Nantong, 226361, China
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Neijiang, 641100, China
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Shanghai, 200032, China
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Shanghai, 201508, China
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Shenyang, 110001, China
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Shenzhen, 518053, China
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Tianjin, 300170, China
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Wuhan, 430010, China
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Wuhan, 430079, China
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Xi'an, 710061, China
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Zhengzhou, 450008, China
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Zhuhai, 519000, China
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Bobigny, 93000, France
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Clichy, 92210, France
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Grenoble, 38043, France
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Montpellier, 34295, France
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Nice, 06202, France
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Paris, 75651, France
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Pessac, 33604, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54511, France
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Hong Kong, 999077, Hong Kong
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Shatin, 00000, Hong Kong
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Bangalore, 560068, India
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Bengaluru, 560076, India
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Hyderabad, 500004, India
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Kolkata, 700054, India
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Kolkata, 700160, India
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Madurai, 625107, India
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Mumbai, 400 012, India
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Nashik, 422002, India
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Pune, 411004, India
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Surat, 395002, India
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Vijayawada, 520002, India
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Visakhapatnam, 530017, India
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Arezzo, 52100, Italy
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Brescia, 25100, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Pisa, 56124, Italy
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Bunkyō City, 113-8655, Japan
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Chiba, 260-8677, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 810-8563, Japan
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Hiroshima, 734-8551, Japan
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Kurume-shi, 830-0011, Japan
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Musashino-shi, 180-8610, Japan
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Nagoya, 464-8681, Japan
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Okayama, 700-8558, Japan
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Osaka, 534-0021, Japan
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Osaka, 545-8586, Japan
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Osakasayama-shi, 589-8511, Japan
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Sapporo, 006-8555, Japan
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Shiwa-gun, 028-3695, Japan
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Tsu, 514-8507, Japan
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Yokohama, 241-8515, Japan
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Alc. Cuauhtémoc, 06100, Mexico
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Culiacán, 80230, Mexico
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Guadalajara, 44280, Mexico
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Mérida, 97134, Mexico
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México, 14080, Mexico
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Monterrey, 64460, Mexico
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Monterrey, 64710, Mexico
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Tuxtla Gutiérrez, 29090, Mexico
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Barnaul, 656049, Russia
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Kazan', 420029, Russia
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Moscow, 115478, Russia
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Novosibirsk, 630007, Russia
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Obninsk, 249031, Russia
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Saint Petersburg, 197758, Russia
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Yekaterinburg, 620905, Russia
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Singapore, 168583, Singapore
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Busan, 49241, South Korea
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Daegu, 41944, South Korea
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Goyang-si, 10408, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Córdoba, 14004, Spain
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Madrid, 28007, Spain
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Pamplona, 31008, Spain
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San Sebastián(Guipuzcoa), 20014, Spain
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Kaohsiung City, 833, Taiwan
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Liou Ying Township, 736, Taiwan
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Taichung, 404, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10300, Thailand
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Bangkok, 10400, Thailand
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Chiang Mai, 50200, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Phisanulok, 65000, Thailand
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Hanoi, 100000, Vietnam
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Hanoi, 123, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
Related Publications (2)
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.
PMID: 39798579DERIVEDKloeckner 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.
PMID: 32557715DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno Sangro, MD
Clinica Universidad de Navarra
- PRINCIPAL INVESTIGATOR
Riccardo Lencioni, MD FSIR EBIR
University of Pisa / Miami Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2018
First Posted
December 19, 2018
Study Start
November 30, 2018
Primary Completion
September 11, 2023
Study Completion (Estimated)
August 31, 2026
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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.