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Brief Title: Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
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
Study ID: NCT03298451
Brief 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
Detailed Description: The study population includes patients 18 years of age or older with advanced HCC, Barcelona Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh A classification liver disease. Patients must not have received any prior systemic therapy for unresectable HCC. Patients in all treatment arms may continue receiving their originally assigned treatment, at the Investigator's discretion, until progression Patients in all arms with confirmed PD who, in the Investigator's opinion, continue to receive benefit from their assigned treatment and meet the criteria for treatment in the setting of PD may continue to receive their assigned treatment. If a patient discontinues study drug(s) due to disease progression, the patient will enter survival follow-up. Patients who have discontinued treatment due to toxicity or symptomatic deterioration or who have commenced subsequent anticancer therapy, will have tumor assessments until confirmed PD and will be followed for survival
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Los Angeles, California, United States
Research Site, Orange, California, United States
Research Site, San Francisco, California, United States
Research Site, Washington, District of Columbia, United States
Research Site, Fort Myers, Florida, United States
Research Site, Jacksonville, Florida, United States
Research Site, Westwood, Kansas, United States
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Research Site, Murray, Utah, United States
Research Site, Barretos, , Brazil
Research Site, Curitiba, , Brazil
Research Site, Florianopolis, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Rio de Janeiro, , Brazil
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Research Site, Calgary, Alberta, Canada
Research Site, Edmonton, Alberta, Canada
Research Site, Hamilton, Ontario, Canada
Research Site, Kingston, Ontario, Canada
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Research Site, Montreal, Quebec, Canada
Research Site, Quebec City, Quebec, Canada
Research Site, Sherbrooke, Quebec, Canada
Research Site, Beijing, , China
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Research Site, Dalian, , China
Research Site, Fuzhou, , China
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Research Site, Hefei, , China
Research Site, Nanchang, , China
Research Site, Nanjing, , China
Research Site, Nanning, , China
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Research Site, Xian, , China
Research Site, Zhengzhou, , China
Research Site, Clichy, , France
Research Site, Lile, , France
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Research Site, Saint-Etienne, , France
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Research Site, Hannover, , Germany
Research Site, Heidelberg, , Germany
Research Site, Koeln, , Germany
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Research Site, Muenchen, , Germany
Research Site, Tuebingen, , Germany
Research Site, Ulm, , Germany
Research Site, Hong Kong, , Hong Kong
Research Site, Bangalore, , India
Research Site, Bhubneshwar, , India
Research Site, Chennai, , India
Research Site, Hubli, , India
Research Site, Hyderabad, , India
Research Site, Karmsad, , India
Research Site, Mumbai, , India
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Research Site, Benevento, , Italy
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Research Site, Rozzano, , Italy
Research Site, Bunkyoku, , Japan
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Research Site, Fukuoka, , Japan
Research Site, Hiroshima, , Japan
Research Site, Iizuka, , Japan
Research Site, Kanazawa, , Japan
Research Site, Kotoku, , Japan
Research Site, Kumamoto, , Japan
Research Site, Kurume, , Japan
Research Site, Matsuyama, , Japan
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Research Site, Okayama, , Japan
Research Site, Osaka Sayama, , Japan
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Research Site, Suntogun, , Japan
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Research Site, Yokohama, , Japan
Research Site, Ilsan, Gyeonggi-do, Korea, Republic of
Research Site, Seongnam-si, Gyeonggi-do, Korea, Republic of
Research Site, Busan, , Korea, Republic of
Research Site, Daegu, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
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Research Site, Moscow, , Russian Federation
Research Site, Murmansk, , Russian Federation
Research Site, Nizhniy Novgorod, , Russian Federation
Research Site, Novosibirsk, , Russian Federation
Research Site, Obninsk, , Russian Federation
Research Site, Omsk, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Ufa, , Russian Federation
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Oviedo, , Spain
Research Site, Pamplona Madrid, , Spain
Research Site, Santander, , Spain
Research Site, Chiayi, , Taiwan
Research Site, Kaohsiung, , Taiwan
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Research Site, Taipei, , Taiwan
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Research Site, Bangkok, , Thailand
Research Site, Chang Mai, , Thailand
Research Site, Khon Kaen, , Thailand
Research Site, Phitsanulok, , Thailand
Research Site, Songkhla, , Thailand
Research Site, Dnipro, , Ukraine
Research Site, IvanoFrankivsk, , Ukraine
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Research Site, Kropyvnitskyi, , Ukraine
Research Site, Kyiv, , Ukraine
Research Site, Lviv, , Ukraine
Research Site, Odesa, , Ukraine
Research Site, Uzhgorod, , Ukraine
Research Site, Hanoi, , Vietnam
Research Site, Hochiminh, , Vietnam