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Spots Global Cancer Trial Database for Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

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Trial Identification

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

Study Description

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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Research Site, Baltimore, Maryland, United States

Research Site, Ann Arbor, Michigan, United States

Research Site, Rochester, Minnesota, United States

Research Site, New York, New York, United States

Research Site, Charlotte, North Carolina, United States

Research Site, Portland, Oregon, United States

Research Site, Pittsburgh, Pennsylvania, United States

Research Site, Dallas, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Houston, Texas, United States

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

Research Site, Sao Paulo, , Brazil

Research Site, Calgary, Alberta, Canada

Research Site, Edmonton, Alberta, Canada

Research Site, Hamilton, Ontario, Canada

Research Site, Kingston, Ontario, Canada

Research Site, London, Ontario, Canada

Research Site, Toronto, Ontario, Canada

Research Site, Montreal, Quebec, Canada

Research Site, Quebec City, Quebec, Canada

Research Site, Sherbrooke, Quebec, Canada

Research Site, Beijing, , China

Research Site, Changchun, , China

Research Site, Changsha, , China

Research Site, Chengdu, , China

Research Site, Dalian, , China

Research Site, Fuzhou, , China

Research Site, Guangzhou, , China

Research Site, Hangzhou, , China

Research Site, Harbin, , China

Research Site, Hefei, , China

Research Site, Nanchang, , China

Research Site, Nanjing, , China

Research Site, Nanning, , China

Research Site, Shanghai, , China

Research Site, Suzhou, , China

Research Site, Wuhan, , China

Research Site, Xian, , China

Research Site, Zhengzhou, , China

Research Site, Clichy, , France

Research Site, Lile, , France

Research Site, Marseille, , France

Research Site, Montpellier, , France

Research Site, Nancy, , France

Research Site, Nantes, , France

Research Site, Nice, , France

Research Site, Pessac, , France

Research Site, Poitiers, , France

Research Site, Reims, , France

Research Site, Rouen, , France

Research Site, Saint-Etienne, , France

Research Site, Toulouse, , France

Research Site, Villejuif, , France

Research Site, Aachen, , Germany

Research Site, Essen, , Germany

Research Site, Hannover, , Germany

Research Site, Heidelberg, , Germany

Research Site, Koeln, , Germany

Research Site, Leipzig, , Germany

Research Site, Mainz, , Germany

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

Research Site, Nashik, , India

Research Site, New Delhi, , India

Research Site, Benevento, , Italy

Research Site, Meldola, , Italy

Research Site, Milano, , Italy

Research Site, Napoli, , Italy

Research Site, Perugia, , Italy

Research Site, Pisa, , Italy

Research Site, Roma, , Italy

Research Site, Rozzano, , Italy

Research Site, Bunkyoku, , Japan

Research Site, Chiba, , Japan

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

Research Site, Mitakashi, , Japan

Research Site, Musashino, , Japan

Research Site, Nagoya, , Japan

Research Site, Ogaki, , Japan

Research Site, Okayama, , Japan

Research Site, Osaka Sayama, , Japan

Research Site, Osaka, , Japan

Research Site, Saga, , Japan

Research Site, Sapporo, , Japan

Research Site, Shiwa, , Japan

Research Site, Suntogun, , Japan

Research Site, Tsu, , Japan

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

Research Site, Seoul, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

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

Research Site, Taichung, , Taiwan

Research Site, Tainan, , Taiwan

Research Site, Taipei, , Taiwan

Research Site, Taoyuan, , Taiwan

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

Research Site, Kharkiv, , Ukraine

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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