Hepatocellular CarcinomaPhase 3EMERALD-2NCT03847428
Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
A Phase 3 study testing Durvalumab and Bevacizumab in people with Hepatocellular Carcinoma, run by AstraZeneca at 217 sites in 24 countries.
Trial summary
A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence. Read more about this study
- Who is it for?
- Ages 18 to 150 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Durvalumab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 908 participants
- Where
- 217 sitesin 24 countries
- Study dates
- 29 Apr 2019to 27 Jul 2026
- Phase
- Phase 3
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 150 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
- Imaging to confirm disease-free status within 28 days prior to randomization
- ECOG 0-1 at enrolment
- Child-Pugh score of 5 or 6
- Adequate organ and marrow function.
Who cannot join
- Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
- Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging
- History of hepatic encephalopathy within 12 months prior to randomization
- Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging
- Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
- Active co-infection with HBV and HDV.
- Receipt of prior systemic anticancer therapy for HCC
- Those on a waiting list for liver transplantation
Trial locations and contacts
217 sites in 24 countries.
217 sites in 24 countries
United States34 sites
Research Site
Albuquerque, New Mexico, 87109
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Birmingham, Alabama, 35233
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Chicago, Illinois, 60637
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Cleveland, Ohio, 44106
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Costa Mesa, California, 92627
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Dallas, Texas, 75216
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Detroit, Michigan, 48201
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Durham, North Carolina, 27710
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Grand Rapids, Michigan, 49503
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Honolulu, Hawaii, 96819
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Knoxville, Tennessee, 37916
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La Jolla, California, 92093-0698
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Long Beach, California, 90806
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Louisville, Kentucky, 40206
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Madison, Wisconsin, 53715
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Memphis, Tennessee, 38104
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Miami, Florida, 33176
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Mobile, Alabama, 36604
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New Brunswick, New Jersey, 08903
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New York, New York, 10021
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Omaha, Nebraska, 68198
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Orange, California, 92868
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Philadelphia, Pennsylvania, 19104
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Phoenix, Arizona, 85054
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Pittsburgh, Pennsylvania, 15212
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Rochester, Minnesota, 55905
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Sacramento, California, 95817
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Shreveport, Louisiana, 71103
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Spartanburg, South Carolina, 29303
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Stony Brook, New York, 11794
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Tampa, Florida, 33606
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Washington D.C., District of Columbia, 20007
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Westwood, Kansas, 66205
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Winston-Salem, North Carolina, 27157
Japan31 sites
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Bunkyō City, 113-8655
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Fukuoka, 810-8563
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Gifu, 500-8513
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Hiroshima, 734-8551
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Kōtoku, 135-8550
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Kumamoto, 860-8556
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Kurume-shi, 830-0011
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Kyoto, 606-8507
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Kyoto, 612-8555
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Matsuyama, 790-8524
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Mitaka-shi, 181-8611
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Musashino-shi, 180-8610
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Nagasaki, 852-8501
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Nagoya, 466-8560
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Nagoya, 467-8602
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Osaka, 534-0021
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Osaka, 541-8567
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Osaka, 543-8555
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Osakasayama-shi, 589-8511
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Sapporo, 006-8555
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Sapporo, 060-0033
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Sendai, 980-0872
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Shinagawa-ku, 142-8666
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Shinjuku-ku, 160-0023
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Shinjuku-ku, 162-8655
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Shiwa-gun, 028-3695
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Takasaki-shi, 370-0829
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Tsu, 514-8507
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Wakayama, 641-8510
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Yokohama, 241-8515
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Yokohama, 245-8575
China28 sites
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Beijing, 100021
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Beijing, 100142
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Beijing, 100730
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Bengbu, 233004
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Changchun, 130021
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Changsha, 410013
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Chengdu, 610041
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Fuzhou, 350005
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Guangzhou, 510000
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Guangzhou, 510080
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Guangzhou, 510515
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Hangzhou, 310003
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Hangzhou, 310016
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Hangzhou, 310022
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Harbin, 150049
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Hefei, 230001
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Hohhot, 010010
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Nanjing, 2100008
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Nanjing, 210002
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Ningbo, 315100
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Shanghai, 200032
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Shanghai, 201114
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Shanghai, 201318
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Tianjin, 300170
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Ürümqi, 830000
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Wuhan, 430079
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Xi'an, 710061
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Zhengzhou, 450052
France11 sites
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Amiens, 88054
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Angers, 49933
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Besançon, 25000
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Clichy, 92110
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Dijon, 21079
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Nantes, 44093
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Nice, 06200
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Paris, 75571
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Pessac, 33604
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Toulouse, 31059
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Tours, 37049
Germany10 sites
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Berlin, 13353
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Bonn, 53105
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Chemnitz, 09116
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Cologne, 50937
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Freiburg im Breisgau, 79106
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Heidelberg, 69120
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Leipzig, 04103
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Lübeck, 23538
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München, 81377
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Tübingen, 72076
Brazil8 sites
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Florianópolis, 88034-000
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Porto Alegre, 90020-090
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Porto Alegre, 90035-003
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Rio de Janeiro, 20231-050
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Santa Maria, 97015-450
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Santo André, 09060-870
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São José do Rio Preto, 15090-000
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Vitória, 29043-272
Egypt8 sites
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Alexandria, 21131
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Asyut, 71511
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Cairo, 11451
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Cairo, 11588
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Cairo, 11796
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Dakahlia, 35516
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New Cairo, 11566
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Shebeen El Kom, 32511
India8 sites
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Bangalore, 560027
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Bangalore, 560092
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Hyderabad, 500032
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Kolkata, 700160
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Mumbai, 400012
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New Delhi, 110017
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New Delhi, 110076
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New Delhi, 110085
Russia8 sites
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Barnaul, 656049
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Moscow, 119421
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Moscow, 125284
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Obninsk, 249031
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Saint Petersburg, 197022
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Saint Petersburg, 197044
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Saint Petersburg, 197758
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Yekaterinburg, 620905
Thailand8 sites
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Bangkok, 10210
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Bangkok, 10300
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Bangkok, 10330
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Bangkok, 10700
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Chiang Mai, 50200
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Hat Yai, 90110
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Khon Kaen, 40002
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Pathum Thani, 12120
Italy7 sites
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Bologna, 40138
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Milan, 20132
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Milan, 20162
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Naples, 80131
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Roma, 00168
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Tricase, Lecce, 73039
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Verona, 37134
Canada6 sites
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Hamilton, Ontario, L8V 5C2
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Kingston, Ontario, K7L 2V7
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Ottawa, Ontario, K1H 8L6
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Québec, Quebec, G1R 2J6
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Toronto, Ontario, M4N 3M5
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Toronto, Ontario, M5G 2M9
Hong Kong6 sites
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Hong Kong, 0000
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Hong Kong, 150001
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Hong Kong, 999077
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Hong Kong
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Kwai Chung, 999077
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Shatin, 00000
South Korea6 sites
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Busan, 49241
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Daegu, 41944
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Seoul, 03080
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Seoul, 03722
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Seoul, 05505
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Seoul, 06351
Taiwan6 sites
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Changhua, 500
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Tainan, 710
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Taipei, 10002
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Taipei, 11217
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Taoyuan City, 333
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Yunlin, 640
Turkey (Türkiye)5 sites
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Ankara, 06100
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Ankara, 6200
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Istanbul, 34098
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Izmir, 35100
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Malatya, 44100
Vietnam5 sites
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Hanoi, 100000
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Hanoi, 123
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Ho Chi Minh City, 700000
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Ho Chi Minh City
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Hochiminh, 70000
Australia4 sites
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Kogarah, 2217
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Melbourne, 3004
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Nedlands, 6009
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Westmead, 2145
Peru4 sites
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Lima, LIMA 31
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Lima, LIMA 34
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Lima, LIMA 41
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San Isidro, 27
Poland4 sites
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Bydgoszcz, 85-796
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Gdansk, 80-952
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Poznan, 61-866
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Warsaw, 02-034
Austria3 sites
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Innsbruck, 6020
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Linz, 4010
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Sankt Pölten, 3100
Philippines3 sites
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City of Muntinlupa, 1780
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Manila, 1000
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Pasig, 1605
Singapore3 sites
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Singapore, 119074
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Singapore, 308433
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Singapore, 329563
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.
Read the detailed description
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab monotherapy or placebo as adjuvant therapy. This study will be conducted in patients with HCC who are at high risk of recurrence after curative hepatic resection or ablation.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Durvalumab, Bevacizumab, Placebo
- Keywords
- Early stage HCC, 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 IMFINZI
Durvalumab IV (intravenous)
BevacizumabDrug
Also called AVASTIN
Bevacizumab IV (intravenous)
PlaceboOther
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous) or Dextrose for Durvalumab masking
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W) Receives: Drug: Durvalumab; Drug: Bevacizumab |
| Arm B | Experimental | Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W) Receives: Drug: Durvalumab; Other: Placebo |
| Arm C | Placebo comparator | Durvalumab placebo (Q3W) + bevacizumab placebo (Q3W) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival (RFS) for Arm A vs Arm C
RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
Measured: Up to 49 months after first patient randomized
Secondary outcomes (5)
Recurrence-free survival (RFS) Arm B vs Arm C
RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
Measured: Up to 49 months after first patient randomized
Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C
OS is defined as the time from the date of randomization until death due to any cause
Measured: No timeframe
Recurrence-free survival at 24 months (RFS24) and 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C
Proportion of RFS at 24 months and at 36 months
Measured: At 24 and at 36 months
Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C
TTR is defined as the time from the date of randomization until the date of disease recurrence
Measured: Up to 49 months after first patient randomized
Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C
Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)
Measured: Up to 49 months after first patient randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start29 Apr 2019
- Primary completion15 May 2026
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 908 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jia Fan, PhD, Principal investigator, Liver Cancer Institute Zhongshan Hospital, Fudan UniversityJennifer Knox, MD, Principal investigator, Solid Tumor Medical Oncology Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847428
- Sponsor's protocol ID
- D910DC00001
- Other IDs
- 2023-507689-26-00, 2018-004105-85, 2018, 2023
- Acronym
- EMERALD-2
- Status last verified
- Oct 2026
- First submitted
- 18 Feb 2019
- Last updated
- 8 Oct 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