Esophageal Cancer Clinical Trial
Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
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).
Full Description
Approximately 600 patients with locally advanced, unresectable ESCC (AJCC 8th cStage II-IVA) will be randomized in a 2:1 ratio to receive either durvalumab + dCRT or placebo + dCRT. The primary objectives of this study are to assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in terms of progression free survival (PFS, per RECIST 1.1 as assessed by BICR) in all randomized patients (intent-to-treat [ITT] population) and PFS in patients with immunotherapy-drugs-are-boosting-survival/" >PD-L1 high tumors (PD-L1 High population).
Eligibility Criteria
Inclusion Criteria:
18 years or older at the time of signing the ICF.
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:
Histologically or cytologically confirmed small cell esophageal carcinoma, esophageal adenocarcinoma or other mixed carcinoma.
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.
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There are 155 Locations for this study
Tucson Arizona, 85719, United States
Palm Springs California, 92262, United States
Washington District of Columbia, 20007, United States
Atlanta Georgia, 30308, United States
Louisville Kentucky, 40217, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48201, United States
Rochester New York, 14642, United States
Memphis Tennessee, 38104, United States
Dallas Texas, 75235, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Morgantown West Virginia, 26506, United States
Brussel , 1090, Belgium
Charleroi , 6000, Belgium
Gent , 9000, Belgium
Liège , 4000, Belgium
Namur , 5000, Belgium
Barretos , 14784, Brazil
Fortaleza , 60430, Brazil
Porto Alegre , 90050, Brazil
Porto Alegre , 91350, Brazil
Rio de Janeiro , 20231, Brazil
Sao Paulo , 04543, Brazil
São José do Rio Preto , 15090, Brazil
São Paulo , 04038, Brazil
Vitoria , 29043, Brazil
Barrie Ontario, L4M 6, Canada
Oshawa Ontario, L1G 2, Canada
Sudbury Ontario, P3E 5, Canada
Anyang , 45500, China
Beijing , 10002, China
Beijing , 10003, China
Bengbu , 23306, China
Changsha , 41001, China
Changzhi , 46000, China
Chengdu , 61004, China
Chongqing , 40003, China
Fuzhou , 35000, China
Fuzhou , 35001, China
Guangzhou , 51000, China
Guangzhou , 51006, China
Guangzhou , 51006, China
Hangzhou , 31005, China
Hangzhou , , China
Hefei , 23003, China
Huai'an , 22330, China
Jieyang , 52200, China
Jinan , 25011, China
Kunming , 65011, China
Liangyugang , 22200, China
Lu'an , 23700, China
Nanjing , 21000, China
Nantong , 22636, China
Qingdao , 26604, China
Quanzhou , 36200, China
Shenzhen , 51811, China
Shijiazhuang , 05002, China
Tianjin , 30006, China
Xi'an , 71006, China
Xuzhou , 22100, China
Xuzhou , 22100, China
Yangzhou , 22500, China
Zhengzhou , 45000, China
Zhengzhou , 45000, China
Zhenjiang , 21200, China
BESANCON Cedex , 25030, France
Lille , 59000, France
Lyon , 69008, France
Montpellier , 34070, France
Reims , 51100, France
Rouen Cedex , 76031, France
Strasbourg , 67033, France
Villejuif Cedex , 94805, France
Bunkyo-ku , 113-8, Japan
Chuo-ku , 104-0, Japan
Hidaka-shi , 350-1, Japan
Hirakata-shi , 573-1, Japan
Hiroshima-shi , 730-8, Japan
Kashiwa , 277-8, Japan
Kitaadachi-gun , 362-0, Japan
Koto-ku , 135-8, Japan
Kumamoto-shi , 860-8, Japan
Maebashi-shi , 371-8, Japan
Niigata-shi , 951-8, Japan
Okayama-shi , 700-8, Japan
Osaka-shi , 541-8, Japan
Osaka-shi , 545-8, Japan
Ota-shi , 373-8, Japan
Sendai-shi , 980-8, Japan
Shinagawa-ku , 142-8, Japan
Yokohama-shi , 232-0, Japan
Yokohama-shi , 241-8, Japan
Daegu , 41404, Korea, Republic of
Seoul , 06273, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 08308, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Suwon , 16247, Korea, Republic of
Chihuahua , 31210, Mexico
Cuernavaca , 62290, Mexico
Leon , 37178, Mexico
Monterrey , 66220, Mexico
Mérida , 97134, Mexico
San Luis Potosà , 78250, Mexico
Veracruz , 91851, Mexico
Den Haag , 2545 , Netherlands
Nijmegen , 6525 , Netherlands
Bellavista , CALLA, Peru
Concepción , 12125, Peru
Lima , 15036, Peru
Lima , 15038, Peru
Lima , Lima , Peru
Katowice , 40-07, Poland
Kraków , 31-11, Poland
Siedlce , 08-11, Poland
Warszawa , 02-03, Poland
Åódź , 90-51, Poland
Chelyabinsk , 45408, Russian Federation
Ekaterinburg , 62090, Russian Federation
Krasnodar , 35004, Russian Federation
Moscow , 11547, Russian Federation
Obninsk , 24903, Russian Federation
Saint Petersburg , 19775, Russian Federation
Sankt-Peterburg , 19775, Russian Federation
Tyumen , 62500, Russian Federation
Ufa , 45005, Russian Federation
Barcelona , 8035, Spain
Córdoba , 14004, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Pamplona , 31008, Spain
Santander , 39008, Spain
Zaragoza , 50009, Spain
Changhua , 50006, Taiwan
Kaohsiung , 80756, Taiwan
Kaohsiung , 824, Taiwan
Kaohsiung , 83301, Taiwan
Taichung , 40443, Taiwan
Taichung , 407, Taiwan
Tainan , 710, Taiwan
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
Tao-Yuan , 333, Taiwan
Bangkok , 10210, Thailand
Bangkok , 10300, Thailand
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Chiang Mai , 50200, Thailand
Hat Yai , 90110, Thailand
Khon Kaen , 40002, Thailand
Mueang Chanthaburi , 22000, Thailand
Ankara , 06800, Turkey
Diyarbakir , 21280, Turkey
Erzurum , 25240, Turkey
Goztepe Istanbul , , Turkey
Izmir , 35575, Turkey
Van , 65080, Turkey
Ha Noi , 10000, Vietnam
Hanoi , 10000, Vietnam
Ho Chi Minh , 70000, Vietnam
Ho Chi Minh , , Vietnam
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