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Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Sponsor: AstraZeneca
Summary
This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy
Official title: A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
1324
Start Date
2017-10-11
Completion Date
2026-08-27
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Durvalumab
Durvalumab IV (intravenous infusion).
Tremelimumab (Regimen 1)
Tremelimumab IV (intravenous infusion).
Tremelimumab (Regimen 2)
Tremelimumab IV (intravenous infusion).
Sorafenib
Sorafenib, as per standard of care
Durvalumab (Regimen 1)
Durvalumab IV (intravenous infusion).
Durvalumab (Regimen 2)
Durvalumab IV (intravenous infusion).
Locations (160)
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Los Angeles, California, United States
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Orange, California, United States
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San Francisco, California, United States
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Washington D.C., District of Columbia, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Westwood, Kansas, United States
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Baltimore, Maryland, United States
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Ann Arbor, Michigan, United States
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Rochester, Minnesota, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Murray, Utah, United States
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Barretos, Brazil
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Curitiba, Brazil
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Florianópolis, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Beijing, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Dalian, China
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Fuzhou, China
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Guangzhou, China
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Hangzhou, China
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Harbin, China
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Hefei, China
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Nanchang, China
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Nanjing, China
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Nanning, China
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Shanghai, China
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Suzhou, China
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Wuhan, China
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Xi'an, China
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Zhengzhou, China
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Clichy, France
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Lille, France
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Marseille, France
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Montpellier, France
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Nancy, France
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Nantes, France
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Nice, France
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Pessac, France
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Poitiers, France
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Reims, France
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Rouen, France
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Saint-Etienne, France
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Toulouse, France
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Villejuif, France
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Aachen, Germany
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Cologne, Germany
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Essen, Germany
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Hanover, Germany
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Heidelberg, Germany
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Leipzig, Germany
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Mainz, Germany
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München, Germany
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Tübingen, Germany
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Ulm, Germany
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Hong Kong, Hong Kong
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Bangalore, India
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Bhubneshwar, India
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Chennai, India
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Hubli, India
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Hyderabad, India
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Karmsad, India
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Mumbai, India
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Nashik, India
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New Delhi, India
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Benevento, Italy
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Meldola, Italy
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Milan, Italy
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Naples, Italy
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Perugia, Italy
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Pisa, Italy
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Roma, Italy
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Rozzano, Italy
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Bunkyoku, Japan
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Chiba, Japan
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Fukuoka, Japan
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Hiroshima, Japan
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Iizuka, Japan
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Kanazawa, Japan
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Kōtoku, Japan
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Kumamoto, Japan
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Kurume, Japan
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Matsuyama, Japan
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Mitakashi, Japan
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Musashino, Japan
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Nagoya, Japan
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Okayama, Japan
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Osaka, Japan
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Ōgaki, Japan
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Ōsaka-sayama, Japan
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Saga, Japan
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Sapporo, Japan
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Shiwa, Japan
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Suntogun, Japan
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Tsu, Japan
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Yokohama, Japan
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Moscow, Russia
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Murmansk, Russia
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Nizhny Novgorod, Russia
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Novosibirsk, Russia
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Obninsk, Russia
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Omsk, Russia
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Saint Petersburg, Russia
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Ufa, Russia
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Ilsan, Gyeonggi-do, South Korea
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Seongnam-si, Gyeonggi-do, South Korea
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Busan, South Korea
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Daegu, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Madrid, Spain
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Oviedo, Spain
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Pamplona Madrid, Spain
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Santander, Spain
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Chiayi City, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Chang Mai, Thailand
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Khon Kaen, Thailand
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Phitsanulok, Thailand
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Songkhla, Thailand
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Dnipro, Ukraine
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IvanoFrankivsk, Ukraine
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Kharkiv, Ukraine
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Kropyvnitskyi, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Uzhhorod, Ukraine
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Hanoi, Vietnam
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Hochiminh, Vietnam