A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
NCT ID: NCT06764875
Last Updated: 2025-12-15
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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RECRUITING
PHASE3
840 participants
INTERVENTIONAL
2025-03-01
2030-12-09
Brief Summary
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Detailed Description
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This study will be conducted at up to 200-250 sites globally in approximately 25 countries.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm A
T-DXd + Rilvegostomig + Fluoropyrimidine (Capecitabine OR 5-FU)
Rilvegostomig
Q3W, intravenous infusion
Trastuzumab deruxtecan
Q3W, intravenous infusion
5-fluorouracil
Q3W, intravenous infusion
Capecitabine
BID, oral administration
Arm B
Pembrolizumab + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)
Trastuzumab
Q3W, intravenous infusion
Pembrolizumab
Q3W, intravenous infusion
5-fluorouracil
Q3W, intravenous infusion
Capecitabine
BID, oral administration
Cisplatin
Q3W, intravenous infusion
Oxaliplatin
Q3W, intravenous infusion
Arm C
Rilvegostomig + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)
Rilvegostomig
Q3W, intravenous infusion
Trastuzumab
Q3W, intravenous infusion
5-fluorouracil
Q3W, intravenous infusion
Capecitabine
BID, oral administration
Cisplatin
Q3W, intravenous infusion
Oxaliplatin
Q3W, intravenous infusion
Interventions
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Rilvegostomig
Q3W, intravenous infusion
Trastuzumab deruxtecan
Q3W, intravenous infusion
Trastuzumab
Q3W, intravenous infusion
Pembrolizumab
Q3W, intravenous infusion
5-fluorouracil
Q3W, intravenous infusion
Capecitabine
BID, oral administration
Cisplatin
Q3W, intravenous infusion
Oxaliplatin
Q3W, intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PD-L1 combined positive score (CPS) ≥ 1.
* Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing.
* Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma.
* WHO or Eastern Cooperative Oncology Group performance status of 0 or 1.
* Have measurable target disease assessed by the Investigator based on RECIST v1.1.
* Have adequate organ and bone marrow function within 14 days before randomization.
* LVEF ≥ 55% within 28 days before randomization.
* Adequate treatment washout period before randomization.
Exclusion Criteria
* Known dihydropyrimidine dehydrogenase enzyme deficiency.
* Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence.
* Persistent toxicities caused by previous anti-cancer therapy.
* Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
* Uncontrolled infection including tuberculosis and active hepatitis A infection.
* Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals.
* Recent receipt of live, attenuated vaccine.
* Chronic/active HBV or HCV infection unless controlled.
* Clinically significant cardiac or psychological conditions.
* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
* History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* Lung-specific intercurrent clinically significant illnesses.
* Any active non-infectious skin disease requiring systemic treatment.
* A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART).
* History of any of the following: drug-induced severe cutaneous adverse reaction.
* Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors.
* Have had major surgical procedure recently (excluding placement of vascular access) or recent significant traumatic injury or an anticipated need for major surgery during the study.
* Current or prior use of immunosuppressive medication within 14 days before study intervention.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Anchorage, Alaska, United States
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Phoenix, Arizona, United States
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Duarte, California, United States
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La Jolla, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Santa Monica, California, United States
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Solvang, California, United States
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Upland, California, United States
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Walnut Creek, California, United States
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Aurora, Colorado, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Hinsdale, Illinois, United States
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Niles, Illinois, United States
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Skokie, Illinois, United States
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Dyer, Indiana, United States
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Louisville, Kentucky, United States
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Silver Spring, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Burnsville, Minnesota, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Reno, Nevada, United States
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Summit, New Jersey, United States
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Santa Fe, New Mexico, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Webster, Texas, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Fairfax, Virginia, United States
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Richmond, Virginia, United States
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Charleston, West Virginia, United States
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Madison, Wisconsin, United States
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Buenos Aires, , Argentina
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Ciudad Autónoma Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Rosario, , Argentina
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Rosario, , Argentina
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Viedma, , Argentina
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Darlinghurst, , Australia
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Heidelberg, , Australia
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Murdoch, , Australia
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Westmead, , Australia
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Linz, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Wiener Neustadt, , Austria
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Edegem, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Barretos, , Brazil
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Brasília, , Brazil
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Campo Grande, , Brazil
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Natal, , Brazil
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Porto Alegre, , Brazil
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Recife, , Brazil
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Salvador, , Brazil
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São Paulo, , Brazil
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Vitória, , Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Montreal, Quebec, Canada
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Port Montt, , Chile
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Rancagua, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Viña del Mar, , Chile
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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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Changchun, , China
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Changsha, , China
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Chengdu, , 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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Guangzhou, , China
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Hangzhou, , China
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Harbin, , China
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Hefei, , China
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Hefei, , China
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Jinan, , China
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Kunming, , China
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Lanzhou, , China
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Linfen, , China
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Linyi, , China
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Nanchang, , China
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Nanjing, , China
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Nanjing, , China
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Shandong, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Shenyang, , China
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Shijiazhuang, , China
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Tianjin, , China
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Wenzhou, , China
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Wuhan, , China
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Xi'an, , China
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Xi'an, , China
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Xining, , China
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Yinchuan, , China
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Zhengzhou, , China
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Bordeaux, , France
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Caen, , France
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Clermont-Ferrand, , France
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Dijon, , France
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Lyon, , France
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Marseille, , France
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Poitiers, , France
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Rennes, , France
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Toulouse, , France
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Villejuif, , France
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Augsburg, , Germany
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Bad Saarow, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Braunschweig, , Germany
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Chemnitz, , Germany
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Düsseldorf, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Göttingen, , Germany
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Hamburg, , Germany
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Leipzig, , Germany
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Ludwigshafen, , Germany
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Mannheim, , Germany
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Ulm, , Germany
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Hong Kong, , Hong Kong
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Hong Kong, , Hong Kong
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Hong Kong, , Hong Kong
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Shatin, , Hong Kong
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Gyöngyös, , Hungary
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Győr, , Hungary
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Gyula, , Hungary
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Zalaegerszeg, , Hungary
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Bangalore, , India
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Delhi, , India
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Delhi, , India
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Hyderabad, , India
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Kolkata, , India
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Mumbai, , India
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Varanasi, , India
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Cagliari, , Italy
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Florence, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Rozzano, , Italy
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Torino, , Italy
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Tricase, , Italy
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Akashi-shi, , Japan
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Bunkyō City, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Fukuoka, , 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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Kasama-shi, , Japan
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Kita-gun, , Japan
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Kitaadachi-gun, , Japan
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Kōtoku, , Japan
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Matsuyama, , Japan
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Niigata, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Ota-shi, , Japan
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Sakaishi, , Japan
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Sendai, , Japan
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Shiwa-gun, , Japan
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Suita-shi, , Japan
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Sunto-gun, , Japan
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Toyoake-shi, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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George Town, , Malaysia
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Ipoh, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Sabak Bernam, , Malaysia
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Amsterdam, , Netherlands
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Arnhem, , Netherlands
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Leiden, , Netherlands
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Arequipa, , Peru
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Callao, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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San Isidro, , Peru
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Bialystok, , Poland
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Gdansk, , Poland
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Koszalin, , Poland
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Olsztyn, , Poland
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Przemyśl, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Rio Piedras, , Puerto Rico
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Daegu, , South Korea
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Goyang-si, , South Korea
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Gyeonggi-do, , South Korea
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Jeonnam, , 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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Seoul, , South Korea
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Seoul, , South Korea
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Badalona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Ourense, , Spain
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Santander, , Spain
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Seville, , Spain
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Valencia, , Spain
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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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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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Banphaeo, , Thailand
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Dusit, , Thailand
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Khon Kaen, , Thailand
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Diyarbakır, , Turkey (Türkiye)
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Erzurum, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Mezitli, , Turkey (Türkiye)
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Cambridge, , United Kingdom
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Coventry, , United Kingdom
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Dundee, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Sutton, , United Kingdom
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Hồ Chí Minh, , Vietnam
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Việt Trì, , Vietnam
Research Site
Vinh, , Vietnam
Countries
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Central Contacts
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Other Identifiers
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2024-512583-57-00
Identifier Type: OTHER
Identifier Source: secondary_id
D702AC00001
Identifier Type: -
Identifier Source: org_study_id
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