Back to resultsStudy of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC (KUNLUN)
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Placebo
cisplatin + fluorouracil
cisplatin + capecitabine
Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Locally Advanced Unrespectable ESCC, PD-L1, Durvalumab
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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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1: Durvalumab + definitive CRT
Arm 2: Placebo + definitive CRT
Arm Description
Durvalumab + concurrent chemoradiation
Placebo + concurrent chemoradiation
Outcomes
Primary Outcome Measures
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
To assess the efficacy in terms of PFS in all randomized patients and in patients with PD-L1 High tumors until disease progression
Secondary Outcome Measures
Overall survival (OS)
To assess the efficacy in terms of OS in all randomized patients and in patients with PD-L1 High tumors until the date of death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04550260
Brief Title
Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
Acronym
KUNLUN
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
November 28, 2025 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
Detailed 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 PD-L1 high tumors (PD-L1 High population).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
Locally Advanced Unrespectable ESCC, PD-L1, Durvalumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor, excluding supply chain management personnel, will remain blinded.
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Durvalumab + definitive CRT
Arm Type
Experimental
Arm Description
Durvalumab + concurrent chemoradiation
Arm Title
Arm 2: Placebo + definitive CRT
Arm Type
Placebo Comparator
Arm Description
Placebo + concurrent chemoradiation
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
Durvalumab intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Durvalumab matching placebo for intravenous infusion
Intervention Type
Drug
Intervention Name(s)
cisplatin + fluorouracil
Intervention Description
cisplatin + fluorouracil, as per Standard of Care
Intervention Type
Drug
Intervention Name(s)
cisplatin + capecitabine
Intervention Description
cisplatin + capecitabine, as per Standard of Care
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
50-64Gy in total
Primary Outcome Measure Information:
Title
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
Description
To assess the efficacy in terms of PFS in all randomized patients and in patients with PD-L1 High tumors until disease progression
Time Frame
up to approximately 56 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
To assess the efficacy in terms of OS in all randomized patients and in patients with PD-L1 High tumors until the date of death
Time Frame
up to approximately 72 months
Other Pre-specified Outcome Measures:
Title
Adverse events (AEs)
Description
To assess the safety and tolerability profile of durvalumab + dCRT compared to placebo + dCRT in patients with ESCC
Time Frame
up to approximately 72 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luhua Wang, MD
Organizational Affiliation
Cancer Hospital of Chinese Academy of Medical Science
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nabil Saba, MD
Organizational Affiliation
Department of Hematology and Medical Oncology, Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
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City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Active, not recruiting
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City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
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Active, not recruiting
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City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
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Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fortaleza
ZIP/Postal Code
60430-230
Country
Brazil
Individual Site Status
Recruiting
Facility Name
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City
Porto Alegre
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Name
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City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
04543-000
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
São José do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
04038-034
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Vitoria
ZIP/Postal Code
29043-260
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Anyang
ZIP/Postal Code
455000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100036
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bengbu
ZIP/Postal Code
233060
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Active, not recruiting
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Research Site
City
Changzhi
ZIP/Postal Code
46000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
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City
Chengdu
ZIP/Postal Code
610042
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350014
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510062
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310052
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Hangzhou
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230031
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Huai'an
ZIP/Postal Code
223300
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Jieyang
ZIP/Postal Code
522000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
2501117
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kunming
ZIP/Postal Code
650118
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Liangyugang
ZIP/Postal Code
222002
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Lu'an
ZIP/Postal Code
237005
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210009
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nantong
ZIP/Postal Code
226361
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Qingdao
ZIP/Postal Code
266042
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Quanzhou
ZIP/Postal Code
362000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Shenzhen
ZIP/Postal Code
518116
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Shijiazhuang
ZIP/Postal Code
050020
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Xuzhou
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xuzhou
ZIP/Postal Code
221005
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Yangzhou
ZIP/Postal Code
225001
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450000
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Zhenjiang
ZIP/Postal Code
212002
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
BESANCON Cedex
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montpellier
ZIP/Postal Code
34070
Country
France
Individual Site Status
Terminated
Facility Name
Research Site
City
Reims
ZIP/Postal Code
51100
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Strasbourg
ZIP/Postal Code
67033
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
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City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Hidaka-shi
ZIP/Postal Code
350-1298
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
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City
Hirakata-shi
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
730-8518
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Kitaadachi-gun
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
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City
Kumamoto-shi
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Maebashi-shi
ZIP/Postal Code
371-8511
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Niigata-shi
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Okayama-shi
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Ota-shi
ZIP/Postal Code
373-8550
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Shinagawa-ku
ZIP/Postal Code
142-8666
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chihuahua
ZIP/Postal Code
31210
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Cuernavaca
ZIP/Postal Code
62290
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Leon
ZIP/Postal Code
37178
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
66220
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Mérida
ZIP/Postal Code
97134
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
San Luis Potosí
ZIP/Postal Code
78250
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Veracruz
ZIP/Postal Code
91851
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Den Haag
ZIP/Postal Code
2545 AA
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bellavista
ZIP/Postal Code
CALLAO 2
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Concepción
ZIP/Postal Code
12125
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15036
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15038
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lima
ZIP/Postal Code
Lima 32
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-074
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-115
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-034
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-513
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Research Site
City
Ekaterinburg
ZIP/Postal Code
620905
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Obninsk
ZIP/Postal Code
249031
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Research Site
City
Tyumen
ZIP/Postal Code
6250041
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Research Site
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
824
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40443
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Tao-Yuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10210
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Mueang Chanthaburi
ZIP/Postal Code
22000
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Completed
Facility Name
Research Site
City
Diyarbakir
ZIP/Postal Code
21280
Country
Turkey
Individual Site Status
Completed
Facility Name
Research Site
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Goztepe Istanbul
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35575
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Van
ZIP/Postal Code
65080
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Ha Noi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh
Country
Vietnam
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
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