Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC

NCT ID: NCT05301842

Last Updated: 2025-01-15

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

760 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-28

Study Completion Date

2027-02-26

Brief Summary

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A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

Detailed Description

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This is a Phase III, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, international study assessing the efficacy and safety of durvalumab + tremelimumab + TACE with or without lenvatinib compared with TACE alone in participants with locoregional HCC not amenable to curative therapy (eg, surgical resection, transplantation, or ablation).

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Open-label

Study Groups

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Arm A

Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)

Group Type EXPERIMENTAL

Tremelimumab

Intervention Type DRUG

Tremelimumab IV (intravenous)

Durvalumab

Intervention Type DRUG

Durvalumab IV (intravenous)

Transarterial Chemoembolization (TACE)

Intervention Type PROCEDURE

TACE (chemo and embolic agent injection into the hepatic artery)

Lenvatinib

Intervention Type DRUG

Lenvatinib (oral)

Arm B

Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)

Group Type EXPERIMENTAL

Tremelimumab

Intervention Type DRUG

Tremelimumab IV (intravenous)

Durvalumab

Intervention Type DRUG

Durvalumab IV (intravenous)

Transarterial Chemoembolization (TACE)

Intervention Type PROCEDURE

TACE (chemo and embolic agent injection into the hepatic artery)

Arm C

Transarterial Chemoembolization (TACE)

Group Type ACTIVE_COMPARATOR

Transarterial Chemoembolization (TACE)

Intervention Type PROCEDURE

TACE (chemo and embolic agent injection into the hepatic artery)

Interventions

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Tremelimumab

Tremelimumab IV (intravenous)

Intervention Type DRUG

Durvalumab

Durvalumab IV (intravenous)

Intervention Type DRUG

Transarterial Chemoembolization (TACE)

TACE (chemo and embolic agent injection into the hepatic artery)

Intervention Type PROCEDURE

Lenvatinib

Lenvatinib (oral)

Intervention Type DRUG

Other Intervention Names

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MEDI1123 MEDI4736 DEB-TACE and cTACE Lenvima

Eligibility Criteria

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Inclusion Criteria

* No evidence of extrahepatic disease
* 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 symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardia arrhythmia
* History of hepatic encephalopathy
* Major portal vein thrombosis visible on baseline imaging
* Uncontrolled arterial hypertension
* Co-infection with HBV and HDV
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

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Countries

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United States Belgium Brazil Canada China Egypt France Germany India Italy Japan Malaysia Mexico Philippines Portugal Puerto Rico Saudi Arabia South Korea Spain Taiwan Thailand Vietnam

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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