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

Last updated: January 14, 2025
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

3

Condition

Carcinoma

Cancer/tumors

Liver Cancer

Treatment

Tremelimumab

Lenvatinib

Durvalumab

Clinical Study ID

NCT05301842
D910VC00001
2021-003822-54
2023-508701-24-00
  • Ages 18-120
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • No evidence of extrahepatic disease

  • Disease not amenable to curative surgery or transplantation or curative ablation butdisease 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

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

Study Design

Total Participants: 760
Treatment Group(s): 4
Primary Treatment: Tremelimumab
Phase: 3
Study Start date:
March 28, 2022
Estimated Completion Date:
February 26, 2027

Study Description

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).

Connect with a study center

  • Research Site

    Brussels, 1070
    Belgium

    Site Not Available

  • Research Site

    Gent, 9000
    Belgium

    Site Not Available

  • Research Site

    Barretos, 14784-400
    Brazil

    Site Not Available

  • Research Site

    Brasilia, 71681-603
    Brazil

    Site Not Available

  • Research Site

    Niterói, 24020-096
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre, 91350-200
    Brazil

    Site Not Available

  • Research Site

    Rio de Janeiro, 20231-050
    Brazil

    Site Not Available

  • Research Site

    Santa Maria, 97015-450
    Brazil

    Site Not Available

  • Research Site

    Santo Andre, 09060-650
    Brazil

    Site Not Available

  • Research Site

    São Paulo, 04014-002
    Brazil

    Site Not Available

  • Research Site

    Vitória, 29043-272
    Brazil

    Site Not Available

  • Research Site

    Calgary, Alberta T2N 5G2
    Canada

    Site Not Available

  • Research Site

    Moncton, New Brunswick E1C 6Z8
    Canada

    Site Not Available

  • Research Site

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • Research Site

    Kingston, Ontario K7L 5P9
    Canada

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    London, Ontario N6C 2R5
    Canada

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    Ottawa, Ontario K1H 8L6
    Canada

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    Toronto, Ontario M5G 2M9
    Canada

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    Montreal, Quebec H4A 3J1
    Canada

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    Beijing, 100069
    China

    Site Not Available

  • Research Site

    Changchun, 130021
    China

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  • Research Site

    Changsha, 410013
    China

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    Chengdu, 610041
    China

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  • Research Site

    Fuzhou, 350011
    China

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    Guangzhou, 510060
    China

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  • Research Site

    Haikou, 570311
    China

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    Hangzhou, 310022
    China

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    Harbin, 150081
    China

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  • Research Site

    Hefei, 230031
    China

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    Lanzhou, 730030
    China

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    Lishui, 323000
    China

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    Nanchang, 330006
    China

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    Nanjing, 210002
    China

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    Nantong, 226361
    China

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    Neijiang, 641000
    China

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    Shanghai, 200032
    China

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    Suzhou, 215004
    China

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    Tianjin, 300170
    China

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    Urumqi, 830000
    China

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    Wenzhou, 325000
    China

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    Wuhan, 430010
    China

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    Xi'an, 710000
    China

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    Zhengzhou, 450008
    China

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    Zhuhai, 519000
    China

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    Alexandria, 21131
    Egypt

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    Cairo, 11451
    Egypt

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    Luxor, 85863
    Egypt

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    Mansoura, 7650001
    Egypt

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    New Cairo, 11566
    Egypt

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    Shebeen El Kom, 32511
    Egypt

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    Angers, 49933
    France

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    Clichy, 92110
    France

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    Creteil, 94010
    France

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    MONTPELLIER Cedex 5, 34295
    France

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    Nantes cedex 1, 44093
    France

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    Nice, 06200
    France

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    Paris, 75013
    France

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    Rennes, 35000
    France

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    Strasbourg, 67091
    France

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    Toulouse, 31059
    France

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    Vandoeuvre Les Nancy, 54511
    France

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    Bonn, 53127
    Germany

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    Chemnitz, 09116
    Germany

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    Dresden, 01307
    Germany

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    Düsseldorf, 40225
    Germany

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    Frankfurt, 60596
    Germany

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    Göttingen, 37075
    Germany

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    Hamburg, 22291
    Germany

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    Hannover, 30625
    Germany

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    Heidelberg, 69120
    Germany

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    Kiel, 24105
    Germany

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    Leipzig, 04103
    Germany

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    Magdeburg, 39120
    Germany

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    Ulm, 89081
    Germany

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    Ahmedabad, 380054
    India

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  • Research Site

    Anand, 388001
    India

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    Bangalore, 560027
    India

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    Delhi, 110029
    India

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    Gurgaon, 122002
    India

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    Gurugram, 122001
    India

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    Hyderabad, 500032
    India

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    JAipur, 302022
    India

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    Kolkata, 700099
    India

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    Ludhiana, 141001
    India

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    Mumbai, 400012
    India

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    Nagpur, 440001
    India

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    New Delhi, 110 085
    India

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    Rishikesh, 249203
    India

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    Arezzo, 52100
    Italy

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    Firenze, 50134
    Italy

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    Milano, 20133
    Italy

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    Roma, 00128
    Italy

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    Rozzano, 20089
    Italy

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    Tricase, 73039
    Italy

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  • Research Site

    Tricase (Lecce), 73039
    Italy

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  • Research Site

    Chuo-ku, 104-0045
    Japan

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  • Research Site

    Fukuoka-shi, 810-8563
    Japan

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  • Research Site

    Hiroshima-shi, 734-8551
    Japan

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  • Research Site

    Kashihara-shi, 634-8522
    Japan

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  • Research Site

    Kashiwa, 277-8577
    Japan

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  • Research Site

    Kumamoto-shi, 860-8556
    Japan

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  • Research Site

    Mitaka-shi, 181-8611
    Japan

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    Morioka-shi, 028-3695
    Japan

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    Musashino-shi, 180-8610
    Japan

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  • Research Site

    Okayama-shi, 700-8558
    Japan

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  • Research Site

    Osaka-shi, 545-8586
    Japan

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  • Research Site

    Osakasayama-shi, 589-8511
    Japan

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  • Research Site

    Sapporo-shi, 006-8555
    Japan

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  • Research Site

    Sendai-shi, 981-0914
    Japan

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  • Research Site

    Sunto-gun, 411-8777
    Japan

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  • Research Site

    Tokushima-shi, 770-8503
    Japan

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  • Research Site

    Tsu-shi, 514-8507
    Japan

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  • Research Site

    Yokohama-shi, 241-8515
    Japan

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  • Research Site

    Busan, 49241
    Korea, Republic of

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  • Research Site

    Daegu, 42601
    Korea, Republic of

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  • Research Site

    Goyang-si, 10408
    Korea, Republic of

    Site Not Available

  • Research Site

    Jung-gu, 41944
    Korea, Republic of

    Site Not Available

  • Research Site

    Seodaemun-gu, 03722
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 06351
    Korea, Republic of

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  • Research Site

    George Town, 10450
    Malaysia

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  • Research Site

    Kuala Lumpur, 59100
    Malaysia

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  • Research Site

    Kuching, 93586
    Malaysia

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  • Research Site

    Puncak Alam, 42300
    Malaysia

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  • Research Site

    Selangor, 62250
    Malaysia

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  • Research Site

    Guadalajara, 44340
    Mexico

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  • Research Site

    Guadalajara, Jalisco, 44280
    Mexico

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  • Research Site

    México, 1400
    Mexico

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  • Research Site

    San Luis Potosí, 78209
    Mexico

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  • Research Site

    Tuxtla Gutierrez, 29090
    Mexico

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  • Research Site

    Davao City, 8000
    Philippines

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  • Research Site

    Makati, 1229
    Philippines

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  • Research Site

    Manila, 1003
    Philippines

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  • Research Site

    Pasig City, 1600
    Philippines

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  • Research Site

    Quezon City, 1112
    Philippines

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  • Research Site

    Lisboa, 1649-035
    Portugal

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  • Research Site

    Vila Real, 5000-508
    Portugal

    Site Not Available

  • Research Site

    Hato Rey Central, 00917
    Puerto Rico

    Site Not Available

  • Research Site

    San Juan, 00927
    Puerto Rico

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  • Research Site

    Moscow, 115478
    Russian Federation

    Site Not Available

  • Research Site

    Ar Riyāḑ, 11426
    Saudi Arabia

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  • Research Site

    Dammam, 31444
    Saudi Arabia

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  • Research Site

    Jeddah, 22384
    Saudi Arabia

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  • Research Site

    Riyadh, 12713
    Saudi Arabia

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  • Research Site

    Barcelona, 08036
    Spain

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  • Research Site

    Cordoba, 14004
    Spain

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  • Research Site

    Madrid, 28034
    Spain

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  • Research Site

    Oviedo, 33006
    Spain

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  • Research Site

    San Sebastian, 20014
    Spain

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  • Research Site

    Taichung, 40705
    Taiwan

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  • Research Site

    Tainan City, 70403
    Taiwan

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  • Research Site

    Taipei, TAIWAN
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Research Site

    Bangkok, 10210
    Thailand

    Site Not Available

  • Research Site

    Chaingmai, 50200
    Thailand

    Site Not Available

  • Research Site

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Research Site

    Hat Yai, 90110
    Thailand

    Site Not Available

  • Research Site

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Research Site

    Phisanulok, 65000
    Thailand

    Site Not Available

  • Research Site

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Research Site

    Mobile, Alabama 36607
    United States

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  • Research Site

    Yuma, Arizona 85364
    United States

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  • Research Site

    Glendale, California 91204
    United States

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  • Research Site

    Weston, Florida 33331
    United States

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  • Research Site

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Research Site

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21201
    United States

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  • Research Site

    Santa Fe, New Mexico 87505
    United States

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  • Research Site

    Commack, New York 11725
    United States

    Site Not Available

  • Research Site

    New York, New York 10029
    United States

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  • Research Site

    Portland, Oregon 97225
    United States

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  • Research Site

    Philadelphia, Pennsylvania 19104
    United States

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  • Research Site

    Memphis, Tennessee 38104
    United States

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  • Research Site

    Dallas, Texas 75235
    United States

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  • Research Site

    Houston, Texas 77030
    United States

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  • Research Site

    Richmond, Virginia 23249
    United States

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  • Research Site

    Ha Noi, 100000
    Vietnam

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  • Research Site

    Hanoi, 100000
    Vietnam

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  • Research Site

    Hcmc, 700000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh, 700000
    Vietnam

    Site Not Available

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