A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1)
July 13, 2026 updated by: AstraZeneca
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
724
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Benowa, Australia, 4217
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Box Hill, Australia, 3128
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Camperdown, Australia, 2050
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Clayton, Australia, 3168
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Herston, Australia, 4029
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Liverpool, Australia, 2170
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Melbourne, Australia, 3004
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Barretos, Brazil, 14784-400
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Florianópolis, Brazil, 88034-000
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Porto Alegre, Brazil, 90035-003
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Porto Alegre, Brazil, 91350-200
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Porto Alegre, Brazil, 90020-090
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Rio de Janeiro, Brazil, 20231-050
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Santa Maria, Brazil, 97015-450
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São José do Rio Preto, Brazil, 15090-000
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São Paulo, Brazil, 01323-903
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Vitória, Brazil, 29043-272
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M5G 2M9
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Toronto, Ontario, Canada, M4N 3M5
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
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Montreal, Quebec, Canada, H2X 3E4
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Beijing, China, 100021
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Beijing, China, 100730
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Beijing, China, 100036
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Beijing, China, 100069
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Changchun, China, 130021
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Changsha, China, 410013
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Chengdu, China, 610041
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Fuzhou, China, 350025
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Fuzhou, China, 350005
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Guangzhou, China, 510080
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Guangzhou, China, 510060
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Guangzhou, China, 510515
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Hangzhou, China, 310022
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Harbin, China, 150081
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Hefei, China, 230001
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Nanchang, China, 330006
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Nanjing, China, 210002
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Nanjing, China, 210009
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Nantong, China, 226361
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Neijiang, China, 641100
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Shanghai, China, 200032
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Shanghai, China, 201508
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Shenyang, China, 110001
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Shenzhen, China, 518053
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Tianjin, China, 300170
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Wuhan, China, 430079
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Wuhan, China, 430010
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Xi'an, China, 710061
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Zhengzhou, China, 450008
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Zhuhai, China, 519000
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Bobigny, France, 93000
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Clichy, France, 92210
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Grenoble, France, 38043
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Montpellier, France, 34295
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Nice, France, 06202
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Paris, France, 75651
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Pessac, France, 33604
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Toulouse, France, 31059
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Vandœuvre-lès-Nancy, France, 54511
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Hong Kong, Hong Kong, 999077
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Shatin, Hong Kong, 00000
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Bangalore, India, 560068
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Bengaluru, India, 560076
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Hyderabad, India, 500004
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Kolkata, India, 700160
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Kolkata, India, 700054
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Madurai, India, 625107
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Mumbai, India, 400 012
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Nashik, India, 422002
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Pune, India, 411004
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Surat, India, 395002
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Vijayawada, India, 520002
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Visakhapatnam, India, 530017
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Arezzo, Italy, 52100
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Brescia, Italy, 25100
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Milan, Italy, 20132
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Milan, Italy, 20133
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Pisa, Italy, 56124
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Bunkyō City, Japan, 113-8655
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Chiba, Japan, 260-8677
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Chūōku, Japan, 104-0045
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Fukuoka, Japan, 810-8563
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Hiroshima, Japan, 734-8551
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Kurume-shi, Japan, 830-0011
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Musashino-shi, Japan, 180-8610
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Nagoya, Japan, 464-8681
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Okayama, Japan, 700-8558
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Osaka, Japan, 545-8586
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Osaka, Japan, 534-0021
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Osakasayama-shi, Japan, 589-8511
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Sapporo, Japan, 006-8555
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Shiwa-gun, Japan, 028-3695
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Tsu, Japan, 514-8507
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Yokohama, Japan, 241-8515
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Alc. Cuauhtémoc, Mexico, 06100
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Culiacán, Mexico, 80230
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Guadalajara, Mexico, 44280
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Monterrey, Mexico, 64460
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Monterrey, Mexico, 64710
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Mérida, Mexico, 97134
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México, Mexico, 14080
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Tuxtla Gutiérrez, Mexico, 29090
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Barnaul, Russia, 656049
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Kazan', Russia, 420029
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Moscow, Russia, 115478
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Novosibirsk, Russia, 630007
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Obninsk, Russia, 249031
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Saint Petersburg, Russia, 197758
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Yekaterinburg, Russia, 620905
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Singapore, Singapore, 168583
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Busan, South Korea, 49241
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Daegu, South Korea, 41944
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Goyang-si, South Korea, 10408
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Seoul, South Korea, 03080
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Seoul, South Korea, 03722
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Seoul, South Korea, 05505
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Seoul, South Korea, 06351
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Córdoba, Spain, 14004
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Madrid, Spain, 28007
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Pamplona, Spain, 31008
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San Sebastián(Guipuzcoa), Spain, 20014
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Kaohsiung City, Taiwan, 833
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Liou Ying Township, Taiwan, 736
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Taichung, Taiwan, 40705
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Taichung, Taiwan, 404
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Tainan, Taiwan, 704
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 11217
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Taoyuan City, Taiwan, 333
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Bangkok, Thailand, 10210
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Bangkok, Thailand, 10300
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Bangkok, Thailand, 10400
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Chiang Mai, Thailand, 50200
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Hat Yai, Thailand, 90110
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Khon Kaen, Thailand, 40002
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Phisanulok, Thailand, 65000
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California
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Costa Mesa, California, United States, 92627
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La Jolla, California, United States, 92093-0698
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Orange, California, United States, 92868
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District of Columbia
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Washington D.C., District of Columbia, United States, 20007
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Florida
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Jacksonville, Florida, United States, 32224
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Miami, Florida, United States, 33136
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Hawaii
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Honolulu, Hawaii, United States, 96819
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Illinois
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Chicago, Illinois, United States, 60612
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Louisiana
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Shreveport, Louisiana, United States, 71103
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Michigan
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Detroit, Michigan, United States, 48201
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Minnesota
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Rochester, Minnesota, United States, 55905-0001
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Missouri
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St Louis, Missouri, United States, 63110
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New York
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Stony Brook, New York, United States, 11794
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North Carolina
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Charlotte, North Carolina, United States, 28204
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Ohio
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Cleveland, Ohio, United States, 44106
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Oregon
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Portland, Oregon, United States, 97213
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15212
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
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Tennessee
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Memphis, Tennessee, United States, 38104
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Texas
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Dallas, Texas, United States, 75235
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Dallas, Texas, United States, 75216
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77090
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
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Hanoi, Vietnam, 100000
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Hanoi, Vietnam, 123
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Ho Chi Minh City, Vietnam, 700000
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Ho Chi Minh City, Vietnam, 70000
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 110 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria:
- 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
Key Exclusion Criteria
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm A
Transarterial Chemoembolization (TACE) in combination with Durvalumab
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Durvalumab IV (intravenous)
Other Names:
TACE (chemo and embolic agent injection into the hepatic artery)
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)
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Experimental: Arm B
Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
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Durvalumab IV (intravenous)
Other Names:
TACE (chemo and embolic agent injection into the hepatic artery)
Bevacizumab IV (intravenous)
Other Names:
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Placebo Comparator: Arm C
Transarterial Chemoembolization (TACE) in combination with Placebos
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TACE (chemo and embolic agent injection into the hepatic artery)
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Progression Free Survival (PFS) for Arm B vs Arm C
Time Frame: Approximately 5 years
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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
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Approximately 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Progression Free Survival (PFS) for Arm A vs Arm C
Time Frame: Approximately 5 years
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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
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Approximately 5 years
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Overall Survival (OS)
Time Frame: Approximately 5 years
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OS is defined as the time from the date of randomization until death due to any cause
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Approximately 5 years
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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)
Time Frame: Approximately 5 years
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Collection of patient reported outcome (PRO) measures to assess time to deterioration in global health status/quality of life (QoL), functioning (physical) and symptoms
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Approximately 5 years
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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)
Time Frame: Approximately 5 years
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Collection of patient reported outcome (PRO) measures to assess time to deterioration in symptoms
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Approximately 5 years
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Safety of Durvalumab and Bevacizumab as evaluated by summary of adverse events by treatment arm and CTCAE grade
Time Frame: Approximately 5 years
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Approximately 5 years
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Immunogenicity of Durvalumab and Bevacizumab as measured by presence of anti-drug antibodies (ADAs)
Time Frame: Approximately 5 years
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Approximately 5 years
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Pharmacokinetics (PK) of Durvalumab and Bevacizumab as determined by peak serum concentrations
Time Frame: Approximately 5 years
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Approximately 5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bruno Sangro, MD, Clinica Universidad de Navarra
- Principal Investigator: Riccardo Lencioni, MD FSIR EBIR, University of Pisa / Miami Cancer Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2018
Primary Completion (Actual)
September 11, 2023
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
November 28, 2018
First Submitted That Met QC Criteria
December 17, 2018
First Posted (Actual)
December 19, 2018
Study Record Updates
Last Update Posted (Actual)
July 15, 2026
Last Update Submitted That Met QC Criteria
July 13, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Digestive System Neoplasms
- Digestive System Diseases
- Liver Diseases
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Carcinoma
- Carcinoma, Hepatocellular
- Liver Neoplasms
- Amino Acids, Peptides, and Proteins
- Proteins
- Antibodies, Monoclonal, Humanized
- Antibodies, Monoclonal
- Antibodies
- Immunoglobulins
- Immunoproteins
- Blood Proteins
- Serum Globulins
- Globulins
- Bevacizumab
- durvalumab
Other Study ID Numbers
- D933GC00001
- 2018-002134-20 (EudraCT Number)
- 2023-509053-32-00 (Registry Identifier: CTIS (EU))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.