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Search / Trial NCT03298451

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

Hepatocellular Carcinoma Non Resectable

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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