Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma
NCT ID: NCT06921785
Last Updated: 2026-01-09
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
1220 participants
INTERVENTIONAL
2025-05-06
2030-03-14
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
SINGLE
Study Groups
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Arm A
Tremelimumab , rilvegostomig and bevacizumab
Tremelimumab
IV therapy
Rilvegostomig
IV therapy
Bevacizumab
IV therapy
Arm B
Rilvegostomig, and bevacizumab
Rilvegostomig
IV therapy
Bevacizumab
IV therapy
Arm C
Atezolizumab, and bevacizumab
Bevacizumab
IV therapy
Atezolizumab
IV therapy
Interventions
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Tremelimumab
IV therapy
Rilvegostomig
IV therapy
Bevacizumab
IV therapy
Atezolizumab
IV therapy
Eligibility Criteria
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Inclusion Criteria
* WHO/ECOG performance status of 0 or 1
* BCLC stage B (that is not eligible for locoregional therapy) or stage C. Child-Pugh Score class A
* At least one measurable target lesion
* co-infected with HBV and HCV are not eligible
* Adequate organ and bone marrow function measured during the screening period
* Must not have received prior systemic therapy for intermediate, advanced, or metastatic HCC.
* Disease that is not amenable to curative surgical and/or locoregional therapies. For participants who received locoregional therapy for HCC, locoregional therapy must have been completed ≥ 28 days prior to the baseline scan for the current study.
Exclusion Criteria
* Any evidence of uncontrolled intercurrent diseases
* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment
* History of another primary malignancy
* Persistent toxicities caused by previous anti-cancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
* Clinically meaningful ascites, pleural effusion, or pericardial effusion requiring non-pharmacologic intervention to maintain symptomatic control within 6 months prior to the first scheduled dose.
* History of active primary immunodeficiency or active infection
* History of hepatic encephalopathy
* Current or recent (within 10 days of first dose of study treatment) use of aspirin (≥ 325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol
* Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purposes is ineligible
Bleeding or other risks
HCC related
* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
* Central nervous system metastases or spinal cord compression (including asymptomatic and adequately treated disease)
* Prior treatment with anti-CTLA-4 and/or anti-TIGIT.
* Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Palo Alto, California, United States
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Santa Monica, California, United States
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New Haven, Connecticut, United States
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Newark, Delaware, United States
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Jacksonville, Florida, United States
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Atlanta, Georgia, United States
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Fayetteville, Georgia, United States
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Chicago, Illinois, United States
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Shreveport, Louisiana, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Rochester, Minnesota, United States
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New Brunswick, New Jersey, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Blacksburg, Virginia, United States
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Fairfax, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Auchenflower, , Australia
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Camperdown, , Australia
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Heidelberg, , Australia
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Porto Alegre, , Brazil
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Santa Maria, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Vitória, , Brazil
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Brampton, Ontario, Canada
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Cambridge, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Chengdu, , China
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Chifeng, , China
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Chongqing, , China
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Deyang, , China
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Fuzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Guiyang, , China
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Harbin, , China
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Hefei, , China
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Hohhot, , China
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Kunming, , China
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Linyi, , China
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Lishui, , China
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Luoyang, , China
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Nanchang, , China
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Nanchang, , China
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Nanjing, , China
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Nanning, , China
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Nantong, , China
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Neijiang, , China
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Shandong, , China
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Shanghai, , China
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Shenyang, , China
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Shenyang, , China
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Weifang, , China
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Wenzhou, , China
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Wuhan, , China
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Xi'an, , China
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Zhengzhou, , China
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Clichy, , France
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Lille, , France
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Lyon, , France
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Nantes, , France
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Nice, , France
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Pessac, , France
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Rennes, , France
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Toulouse, , France
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Aachen, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Dortmund, , Germany
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Dresden, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Frankfurt, , Germany
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Göttingen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Magdeburg, , Germany
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Moers, , Germany
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München, , Germany
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Regensburg, , Germany
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Ulm, , Germany
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Hong Kong, , Hong Kong
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Shatin, , Hong Kong
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Ahmedabad, , India
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Bangalore, , India
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Binnāguri, , India
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Dehradun, , India
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Delhi, , India
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Hyderabad, , India
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Mumbai, , India
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Nashik, , India
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Vadodara, , India
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Bologna, , Italy
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Milan, , Italy
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Milan, , Italy
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Palermo, , Italy
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Perugia, , Italy
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Pisa, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Bunkyō City, , Japan
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Chiba, , Japan
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Fukuoka, , Japan
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Hiroshima, , Japan
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Hiroshima, , Japan
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Iizuka-shi, , Japan
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Kashiwa, , Japan
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Kita-gun, , Japan
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Kobe, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Kurume-shi, , Japan
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Kyoto, , Japan
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Matsuyama, , Japan
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Mitaka-shi, , Japan
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Morioka, , Japan
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Musashino-shi, , Japan
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Nagoya, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Saga, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Suita-shi, , Japan
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Tokyo, , Japan
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Toyoake-shi, , Japan
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Tsu, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Amsterdam, , Netherlands
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Groningen, , Netherlands
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Maastricht, , Netherlands
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Rotterdam, , Netherlands
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Utrecht, , Netherlands
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Busan, , South Korea
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Goyang-si, , South Korea
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Gyeonggi-do, , South Korea
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Seongnam-si, , 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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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Santander, , Spain
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Tainan County, , 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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Chiang Mai, , Thailand
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Dusit, , Thailand
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Hat Yai, , Thailand
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Muang, , Thailand
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Ubonratchathani, , Thailand
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Altındağ, , Turkey (Türkiye)
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Ankara, , 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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Cambridge, , 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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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Other Identifiers
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D7029C00001
Identifier Type: -
Identifier Source: org_study_id
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