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Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
Sponsor: AstraZeneca
Summary
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).
Official title: A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
640
Start Date
2020-10-19
Completion Date
2026-06-02
Last Updated
2026-01-29
Healthy Volunteers
No
Conditions
Interventions
Durvalumab
Durvalumab intravenous infusion
Placebo
Durvalumab matching placebo for intravenous infusion
cisplatin + fluorouracil
cisplatin + fluorouracil, as per Standard of Care
cisplatin + capecitabine
cisplatin + capecitabine, as per Standard of Care
Radiation
50-64Gy in total
Locations (133)
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Atlanta, Georgia, United States
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Louisville, Kentucky, United States
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Dallas, Texas, United States
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Fairfax, Virginia, United States
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Morgantown, West Virginia, United States
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Brussels, Belgium
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Charleroi, Belgium
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Liège, Belgium
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Namur, Belgium
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Barretos, Brazil
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Fortaleza, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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São José do Rio Preto, Brazil
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Vitória, Brazil
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Barrie, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Anyang, China
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Beijing, China
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Beijing, China
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Bengbu, China
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Changsha, China
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Changzhi, China
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Chengdu, China
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Chongqing, China
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Fuzhou, China
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Fuzhou, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Hefei, China
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Huai'an, China
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Jieyang, China
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Jinan, China
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Kunming, China
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Liangyugang, China
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Nantong, China
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Qingdao, China
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Quanzhou, China
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Shenzhen, China
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Tianjin, China
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Xi'an, China
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Xuzhou, China
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Yangzhou, China
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Zhengzhou, China
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Zhenjiang, China
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Besançon, France
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Lille, France
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Lyon, France
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Montpellier, France
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Reims, France
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Rouen, France
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Strasbourg, France
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Villejuif, France
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Bunkyō City, Japan
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Chūōku, Japan
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Hidaka-shi, Japan
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Hirakata-shi, Japan
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Hiroshima, Japan
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Kashiwa, Japan
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Kitaadachi-gun, Japan
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Kōtoku, Japan
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Kumamoto, Japan
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Maebashi, Japan
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Matsuyama, Japan
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Niigata, Japan
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Okayama, Japan
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Osaka, Japan
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Osaka, Japan
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Ota-shi, Japan
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Sendai, Japan
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Shinagawa-ku, Japan
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Yokohama, Japan
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Yokohama, Japan
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Chihuahua City, Mexico
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Cuernavaca, Mexico
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Mérida, Mexico
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Monterrey, Mexico
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Veracruz, Mexico
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Siedlce, Poland
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Warsaw, Poland
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Chelyabinsk, Russia
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Krasnodar, Russia
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Moscow, Russia
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Obninsk, Russia
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Saint Petersburg, Russia
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Tyumen, Russia
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Ufa, Russia
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Yekaterinburg, Russia
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Daegu, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Barcelona, Spain
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Córdoba, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Pamplona, Spain
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Santander, Spain
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Zaragoza, Spain
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Changhua, Taiwan
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Kaohsiung City, Taiwan
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Kaohsiung City, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Bangkok, Thailand
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Bangkok, Thailand
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Bangkok, Thailand
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Chanthaburi, Thailand
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Chiang Mai, Thailand
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Hat Yai, Thailand
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Khon Kaen, Thailand
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Ankara, Turkey (Türkiye)
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Diyarbakır, Turkey (Türkiye)
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Erzurum, Turkey (Türkiye)
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Goztepe Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Van, Turkey (Türkiye)
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam