Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC
NCT ID: NCT05301842
Last Updated: 2025-01-15
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
760 participants
INTERVENTIONAL
2022-03-28
2027-02-26
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, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
Tremelimumab
Tremelimumab IV (intravenous)
Durvalumab
Durvalumab IV (intravenous)
Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Lenvatinib
Lenvatinib (oral)
Arm B
Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)
Tremelimumab
Tremelimumab IV (intravenous)
Durvalumab
Durvalumab IV (intravenous)
Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Arm C
Transarterial Chemoembolization (TACE)
Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Interventions
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Tremelimumab
Tremelimumab IV (intravenous)
Durvalumab
Durvalumab IV (intravenous)
Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Lenvatinib
Lenvatinib (oral)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE
* Child Pugh score class A
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
* Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
* Adequate organ and marrow function
Exclusion Criteria
* History of hepatic encephalopathy
* Major portal vein thrombosis visible on baseline imaging
* Uncontrolled arterial hypertension
* Co-infection with HBV and HDV
18 Years
120 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Yuma, Arizona, United States
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Glendale, California, United States
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Atlanta, Georgia, United States
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Baltimore, Maryland, United States
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Santa Fe, New Mexico, United States
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Commack, New York, United States
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New York, New York, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Brussels, , Belgium
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Ghent, , Belgium
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Barretos, , Brazil
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Brasília, , Brazil
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Niterói, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Santa Maria, , Brazil
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Santo André, , 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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Halifax, Nova Scotia, Canada
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Kingston, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, 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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Fuzhou, , China
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Fuzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Haikou, , China
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Hangzhou, , China
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Harbin, , China
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Hefei, , China
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Lanzhou, , China
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Lishui, , China
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Nanchang, , China
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Nanjing, , China
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Nantong, , China
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Neijiang, , China
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Shanghai, , China
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Suzhou, , China
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Tianjin, , China
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Wenzhou, , China
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Wuhan, , China
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Wuhan, , China
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Xi'an, , China
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Zhengzhou, , China
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Zhuhai, , China
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Al Mansurah, , Egypt
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Cairo, , Egypt
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Shebeen El Kom, , Egypt
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Angers, , France
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Clichy, , France
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Créteil, , France
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Montpellier, , France
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Nantes, , France
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Nice, , France
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Paris, , France
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Strasbourg, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Bonn, , Germany
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Chemnitz, , Germany
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Dresden, , Germany
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Düsseldorf, , 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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Heidelberg, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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Magdeburg, , Germany
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Ulm, , Germany
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Ahmedabad, , India
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Ahmedabad, , India
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Bangalore, , India
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Delhi, , India
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Hyderabad, , India
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Jaipur, , India
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Kolkata, , India
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Mumbai, , India
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New Delhi, , India
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New Delhi, , India
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Arezzo, , Italy
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Florence, , Italy
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Milan, , Italy
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Milan, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Tricase, , Italy
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Chūōku, , Japan
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Fukuoka, , Japan
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Hiroshima, , Japan
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Kashihara-shi, , Japan
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Kashiwa, , Japan
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Kumamoto, , 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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Okayama, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Sunto-gun, , Japan
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Tokushima, , Japan
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Tsu, , Japan
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Yokohama, , Japan
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Bandar Puncak Alam, , Malaysia
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George Town, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Selangor, , Malaysia
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Kuching, , Malaysia
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Guadalajara, Jalisco, , Mexico
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México, , Mexico
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San Luis Potosí City, , Mexico
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Tuxtla Gutiérrez, , Mexico
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Davao City, , Philippines
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Makati, , Philippines
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Manila, , Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Lisbon, , Portugal
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Vila Real, , Portugal
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Hato Rey Central, , Puerto Rico
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San Juan, , Puerto Rico
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Jeddah, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Busan, , South Korea
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Daegu, , South Korea
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Goyang-si, , South Korea
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Junggu, , 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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Córdoba, , Spain
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Donostia / San Sebastian, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan City, , 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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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Hat Yai, , Thailand
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Khon Kaen, , Thailand
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Hanoi, , Vietnam
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Hà Nội, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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2023-508701-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-003822-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D910VC00001
Identifier Type: -
Identifier Source: org_study_id
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