Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Launched by ASTRAZENECA · Sep 26, 2017
Trial Information
Current as of May 21, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness and safety of two treatments, durvalumab plus tremelimumab, compared to another medication called sorafenib for patients with advanced liver cancer, specifically hepatocellular carcinoma (HCC). The trial aims to find out which treatment works better for people who have not received any prior systemic therapy and are not suitable for other local treatments.
To be eligible for this study, participants must have a confirmed diagnosis of HCC and meet certain criteria, including being in specific stages of the disease (B or C) and having a good overall health status. Participants can expect to receive either the combination treatment or sorafenib and will be monitored closely for their health and response to the therapy. It's important to know that this trial is currently active but not recruiting new patients. It focuses on individuals aged 65 and older who have not had any previous systemic therapy for their liver cancer.
Gender
ALL
Eligibility criteria
- • Inclusion criteria
- • HCC based on histopathological confirmation
- • No prior systemic therapy for HCC
- • Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C
- • Child-Pugh Score class A
- • ECOG performance status of 0 or 1 at enrollment
- • Exclusion criteria
- • Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
- • Clinically meaningful ascites
- • Main portal vein tumor thrombosis
- • Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
- • HBV and HVC co-infection, or HBV and Hep D co-infection
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Washington, District Of Columbia, United States
Rochester, Minnesota, United States
Houston, Texas, United States
Montpellier, , France
Essen, , Germany
Mainz, , Germany
Curitiba, , Brazil
Porto Alegre, , Brazil
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Beijing, , China
Shanghai, , China
Toulouse, , France
Heidelberg, , Germany
Leipzig, , Germany
Hong Kong, , Hong Kong
Moscow, , Russian Federation
Barcelona, , Spain
Madrid, , Spain
Taichung, , Taiwan
Taipei, , Taiwan
Ulm, , Germany
Dallas, Texas, United States
Los Angeles, California, United States
Guangzhou, , China
Nantes, , France
Napoli, , Italy
Roma, , Italy
Clichy, , France
Lyon, , France
Nizhniy Novgorod, , Russian Federation
Obninsk, , Russian Federation
Saint Petersburg, , Russian Federation
Aachen, , Germany
Kanpur, , India
Barretos, , Brazil
Florianopolis, , Brazil
Hannover, , Germany
Bangalore, , India
New Delhi, , India
Perugia, , Italy
Pisa, , Italy
Oviedo, , Spain
Nice, , France
Santander, , Spain
Kharkiv, , Ukraine
Lviv, , Ukraine
Poitiers, , France
Kyiv, , Ukraine
Uzhgorod, , Ukraine
Benevento, , Italy
Rozzano, , Italy
Chiayi, , Taiwan
Taoyuan, , Taiwan
Chennai, , India
Bangkok, , Thailand
Pessac, , France
Portland, Oregon, United States
Mumbai, , India
Chiba, , Japan
Fukuoka, , Japan
Kumamoto, , Japan
Osaka, , Japan
Novosibirsk, , Russian Federation
Matsuyama, , Japan
Nagoya, , Japan
Sapporo, , Japan
Kaohsiung, , Taiwan
Tainan, , Taiwan
Villejuif, , France
Khon Kaen, , Thailand
Hanoi, , Vietnam
Hyderabad, , India
Kanazawa, , Japan
Okayama, , Japan
Hiroshima, , Japan
Hamilton, Ontario, Canada
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Marseille, , France
Milano, , Italy
Muenchen, , Germany
Tuebingen, , Germany
Reims, , France
Kingston, Ontario, Canada
Nanjing, , China
Wuhan, , China
Nancy, , France
Orange, California, United States
Chengdu, , China
Hangzhou, , China
Dalian, , China
Fuzhou, , China
Kurume, , Japan
Yokohama, , Japan
Sherbrooke, Quebec, Canada
Nanning, , China
Ann Arbor, Michigan, United States
Koeln, , Germany
Omsk, , Russian Federation
Ufa, , Russian Federation
Nashik, , India
Murmansk, , Russian Federation
Changchun, , China
Meldola, , Italy
Ludhiana, , India
New York, New York, United States
Murray, Utah, United States
Hefei, , China
Phitsanulok, , Thailand
Jacksonville, Florida, United States
Baltimore, Maryland, United States
Zhengzhou, , China
Westwood, Kansas, United States
Saint Etienne, , France
Saga, , Japan
Pittsburgh, Pennsylvania, United States
Changsha, , China
Suzhou, , China
Busan, , Korea, Republic Of
Nanchang, , China
Odesa, , Ukraine
Xian, , China
Hubli, , India
Harbin, , China
Hochiminh, , Vietnam
Songkhla, , Thailand
Seoul, , Korea, Republic Of
Iizuka, , Japan
Charlotte, North Carolina, United States
Daegu, , Korea, Republic Of
Rouen, , France
San Francisco, California, United States
Fort Myers, Florida, United States
Montreal, Quebec, Canada
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Seoul, , Korea, Republic Of
Quebec City, Quebec, Canada
Neijiang, , China
Yibin, , China
Lile, , France
Bhubneshwar, , India
Karmsad, , India
Rozzano (Mi), , Italy
Bunkyoku, , Japan
Kotoku, , Japan
Mitakashi, , Japan
Musashino, , Japan
Ogaki, , Japan
Osaka Sayama, , Japan
Shiwa, , Japan
Suntogun, , Japan
Tsu, , Japan
Ilsan, Gyeonggi Do, Korea, Republic Of
Pamplona Madrid, , Spain
Chang Mai, , Thailand
Dnipro, , Ukraine
Ivanofrankivsk, , Ukraine
Kropyvnitskyi, , Ukraine
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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