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).

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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).

View Eligibility Criteria

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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

600

Study ID:

NCT04550260

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 154 Locations for this study

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Tucson Arizona, 85719, United States
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Palm Springs California, 92262, United States
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Washington District of Columbia, 20007, United States
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Atlanta Georgia, 30308, United States
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Louisville Kentucky, 40217, United States
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Worcester Massachusetts, 01655, United States
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Detroit Michigan, 48201, United States
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Rochester New York, 14642, United States
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Memphis Tennessee, 38104, United States
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Dallas Texas, 75390, United States
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Houston Texas, 77030, United States
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Fairfax Virginia, 22031, United States
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Morgantown West Virginia, 26506, United States
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Brussel , 1090, Belgium
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Charleroi , 6000, Belgium
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Gent , 9000, Belgium
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Liège , 4000, Belgium
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Namur , 5000, Belgium
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Barretos , 14784, Brazil
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Fortaleza , 60430, Brazil
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Porto Alegre , 90050, Brazil
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Porto Alegre , 91350, Brazil
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Rio de Janeiro , 20231, Brazil
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Sao Paulo , 04543, Brazil
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São José do Rio Preto , 15090, Brazil
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São Paulo , 04038, Brazil
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Vitoria , 29043, Brazil
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Barrie Ontario, L4M 6, Canada
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Oshawa Ontario, L1G 2, Canada
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Sudbury Ontario, P3E 5, Canada
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Anyang , 45500, China
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Beijing , 10002, China
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Beijing , 10003, China
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Bengbu , 23306, China
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Changsha , 41001, China
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Chengdu , 61004, China
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Chongqing , 40003, China
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Fuzhou , 35000, China
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Fuzhou , 35001, China
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Guangzhou , 51000, China
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Guangzhou , 51006, China
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Guangzhou , 51006, China
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Hangzhou , 31005, China
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Hangzhou , , China
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Hefei , 23003, China
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Huai'an , 22330, China
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Jieyang , 52200, China
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Jinan , 25011, China
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Kunming , 65011, China
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Liangyugang , 22200, China
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Lu'an , 23700, China
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Nanjing , 21000, China
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Nantong , 22636, China
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Qingdao , 26604, China
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Quanzhou , 36200, China
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Shenzhen , 51811, China
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Shijiazhuang , 05002, China
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Xi'an , 71006, China
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Xuzhou , 22100, China
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Xuzhou , 22100, China
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Yangzhou , 22500, China
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Zhengzhou , 45000, China
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Zhengzhou , 45000, China
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Zhenjiang , 21200, China
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BESANCON Cedex , 25030, France
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Lille , 59000, France
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Lyon , 69008, France
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Marseille , 13385, France
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Montpellier , 34070, France
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Reims , 51100, France
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Rouen Cedex , 76031, France
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Strasbourg , 67033, France
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Villejuif Cedex , 94805, France
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Bunkyo-ku , 113-8, Japan
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Chuo-ku , 104-0, Japan
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Hidaka-shi , 350-1, Japan
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Hirakata-shi , 573-1, Japan
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Hiroshima-shi , 730-8, Japan
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Kashiwa , 277-8, Japan
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Kitaadachi-gun , 362-0, Japan
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Koto-ku , 135-8, Japan
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Kumamoto-shi , 860-8, Japan
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Maebashi-shi , 371-8, Japan
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Matsuyama-shi , 791-0, Japan
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Niigata-shi , 951-8, Japan
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Okayama-shi , 700-8, Japan
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Osaka-shi , 541-8, Japan
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Osaka-shi , 545-8, Japan
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Ota-shi , 373-8, Japan
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Sendai-shi , 980-8, Japan
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Shinagawa-ku , 142-8, Japan
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Yokohama-shi , 232-0, Japan
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Yokohama-shi , 241-8, Japan
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Daegu , 41404, Korea, Republic of
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Seoul , 06273, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Seoul , 08308, Korea, Republic of
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Seoul , 138-7, Korea, Republic of
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Suwon , 16247, Korea, Republic of
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Chihuahua , 31210, Mexico
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Cuernavaca , 62290, Mexico
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Leon , 37178, Mexico
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Monterrey , 66220, Mexico
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Mérida , 97134, Mexico
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San Luis Potosí , 78250, Mexico
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Veracruz , 91851, Mexico
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Den Haag , 2545 , Netherlands
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Nijmegen , 6525 , Netherlands
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Bellavista , CALLA, Peru
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Concepción , 12125, Peru
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Lima , 15036, Peru
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Lima , 15036, Peru
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Lima , 15038, Peru
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Lima , Lima , Peru
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Katowice , 40-07, Poland
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Kraków , 31-11, Poland
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Siedlce , 08-11, Poland
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Warszawa , 02-03, Poland
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Łódź , 90-51, Poland
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Chelyabinsk , 45408, Russian Federation
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Ekaterinburg , 62090, Russian Federation
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Krasnodar , 35004, Russian Federation
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Moscow , 11547, Russian Federation
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Obninsk , 24903, Russian Federation
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Saint Petersburg , 19775, Russian Federation
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Sankt-Peterburg , 19775, Russian Federation
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Tyumen , 62500, Russian Federation
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Ufa , 45005, Russian Federation
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Barcelona , 8035, Spain
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Córdoba , 14004, Spain
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Madrid , 28007, Spain
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Madrid , 28034, Spain
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Madrid , 28046, Spain
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Pamplona , 31008, Spain
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Santander , 39008, Spain
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Zaragoza , 50009, Spain
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Changhua , 50006, Taiwan
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Kaohsiung , 80756, Taiwan
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Kaohsiung , 824, Taiwan
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Kaohsiung , 83301, Taiwan
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Taichung , 40443, Taiwan
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Taichung , 407, Taiwan
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Tainan , 710, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 11217, Taiwan
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Tao-Yuan , 333, Taiwan
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Bangkok , 10210, Thailand
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Bangkok , 10300, Thailand
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Bangkok , 10330, Thailand
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Bangkok , 10400, Thailand
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Chiang Mai , 50200, Thailand
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Hat Yai , 90110, Thailand
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Khon Kaen , 40002, Thailand
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Mueang Chanthaburi , 22000, Thailand
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Ankara , 06800, Turkey
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Diyarbakir , 21280, Turkey
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Erzurum , 25240, Turkey
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Goztepe Istanbul , , Turkey
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Izmir , 35575, Turkey
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Van , 65080, Turkey
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Ha Noi , 10000, Vietnam
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Hanoi , 10000, Vietnam
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Ho Chi Minh , 70000, Vietnam
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Ho Chi Minh , , Vietnam

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

600

Study ID:

NCT04550260

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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