Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
NCT ID: NCT04550260
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
640 participants
INTERVENTIONAL
2020-10-19
2026-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1: Durvalumab + definitive CRT
Durvalumab + concurrent chemoradiation
Durvalumab
Durvalumab 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
Arm 2: Placebo + definitive CRT
Placebo + concurrent chemoradiation
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed esophageal squamous cell carcinoma, and present with locally advanced disease (Stage II-IVA).
* Unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy.
* Patients with at least an evaluable lesion per RECIST 1.1.
* Mandatory provision of available tumor tissue for PD-L1 expression analysis.
* ECOG PS 0 or 1.
* Adequate organ and marrow function.
* Life expectancy of more than 3 months.
Exclusion Criteria
* Prior anti-cancer treatment for ESCC.
* Patient with a great risk of perforation and massive bleeding.
* History of allogeneic organ transplantation.
* Active or prior documented autoimmune or inflammatory disorders.
* Uncontrolled intercurrent illness.
* History of another primary malignancy.
* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Luhua Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital of Chinese Academy of Medical Science
Nabil Saba, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Hematology and Medical Oncology, Emory University
Locations
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Research Site
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 City, , 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)
Research Site
Van, , Turkey (Türkiye)
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Hanoi, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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2020-001001-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D910SC00001
Identifier Type: -
Identifier Source: org_study_id
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