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378 : A phase 3 randomized, double-blind, placebo-controlled study of durvalumab in combination with gemcitabine plus cisplatin (GemCis) in patients (pts) with advanced biliary tract cancer (BTC): TOPAZ-1.

Researchers

Presenter

  • Do-Youn Oh

Principal Investigators

  • Shukui Qin

  • Li-Tzong Chen

  • Takuji Okusaka

  • Arndt Vogel

  • Jin Won Kim

  • Thatthan Suksombooncharoen

  • Myung Ah Lee

  • Masayuki Kitano

  • Howard A. Burris III

  • Mohamed Bouattour

  • Suebpong Tanasanvimon

  • Renata Zaucha

  • Antonio Avallone

  • Juan Cundom

  • Nana Rokutanda

  • Julia Xiong

  • Gordon Cohen

  • Juan W. Valle

Medical Centers

  • Rheumatology, Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea,

  • Georgetown University, Washington, DC

  • Cancer Center of Jinling Hospital, Nanjing, China

  • National Institute of Cancer Research, Miaoli, Taiwan

  • Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan

  • Hannover Medical School, Hannover, Germany

  • Pediatrics, Seoul National University Bundang Hospital, Gyeonggi-do, Korea

  • Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand

  • Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea,

  • Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan

  • Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN

  • AP‐HP Hôpital Beaujon, Paris, France

  • Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand

  • Medical University of Gdansk, Gdansk, Poland

  • Istituto Nazionale Tumori Fondazione G. Pascale, Naples, Italy

  • Instituo de Investigaciones Cardiologicas UBA, Buenos Aires, Argentina

  • AstraZeneca, Gaithersburg, MD

  • AstraZeneca, Boston, MA

  • University of Manchester and The Christie NHS FT, Manchester, United Kingdom

Locations

  • Republic of South Korea

  • United States

  • China

  • Taiwan

  • Japan

  • Germany

  • Thailand

  • France

  • Poland

  • Italy

  • Argentina

  • United Kingdom

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Advanced biliary tract carcinoma

  • Extrahepatic cholangiocarcinoma

  • Gallbladder cancer

  • Solid malignancies

Biomarkers

  • N/A

Drug/Treatment

  • Gemcitabine

  • Durvalumab

  • Cisplatin

Outcome

  • N/A

Study Design

  • Randomized

  • Placebo Control

  • Double Blind/Blinded

  • Controlled

Phase

  • III

Study Id's

  • NCT03875235

Sponsors

  • N/A

Result

  • N/A

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