A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma

Last updated: April 10, 2025
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

3

Condition

Cancer

Abdominal Cancer

Liver Disorders

Treatment

Transarterial Chemoembolization (TACE)

Durvalumab

Placebo

Clinical Study ID

NCT03778957
D933GC00001
2023-509053-32-00
2018-002134-20
  • Ages 18-110
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Key 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 to B7 and 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

Key Exclusion Criteria

  • Any history of nephrotic or nephritic syndrome

  • Clinically significant cardiovascular disease or history of arterioembolic event including a stroke or myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization

  • Any prior or current evidence of coagulopathy or bleeding diathesis or patients who had any kind of surgery in the past 28 days (biopsies are exempt from this exclusion)

  • History of abdominal fistula or GI perforation, non healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment

  • Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded

Study Design

Total Participants: 724
Treatment Group(s): 4
Primary Treatment: Transarterial Chemoembolization (TACE)
Phase: 3
Study Start date:
November 30, 2018
Estimated Completion Date:
August 31, 2026

Study Description

This is a randomized, double-blind, placebo-controlled, multicenter, global Phase III study to determine the efficacy and safety of transarterial chemoembolization (TACE) treatment in combination with durvalumab monotherapy or TACE given with durvalumab plus bevacizumab therapy compared to TACE therapy alone in patients with locoregional hepatocellular carcinoma not amenable to curative therapy

Connect with a study center

  • Research Site

    Benowa, 4217
    Australia

    Site Not Available

  • Research Site

    Box Hill, 3128
    Australia

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  • Research Site

    Camperdown, 2050
    Australia

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    Clayton, 3168
    Australia

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    Fitzroy, 3065
    Australia

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    Herston, 4029
    Australia

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    Liverpool, 2170
    Australia

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    Melbourne, 3004
    Australia

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    Prahan, 3004
    Australia

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    Westmead, 2145
    Australia

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    Barretos, 14784-400
    Brazil

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    Florianópolis, 88034-000
    Brazil

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    Porto Alegre, 91350-200
    Brazil

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    Rio de Janeiro, 20231-050
    Brazil

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    Santa Maria, 97015-450
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    Sao Paulo, 01323-903
    Brazil

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    São José do Rio Preto, 15090-000
    Brazil

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    Vitória, 29043-272
    Brazil

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    Hamilton, Ontario L8V 5C2
    Canada

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    Ottawa, Ontario K1H 8L6
    Canada

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    Toronto, Ontario M5G 2M9
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    Montreal, Quebec H2X 3E4
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    Baoding, 071000
    China

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    Beijing, 100036
    China

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    Changchun, 130021
    China

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    Changsha, 410013
    China

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    Chengdu, 610041
    China

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    Fuzhou, 350005
    China

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    Guangzhou, 510515
    China

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    Hangzhou, 310022
    China

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    Harbin, 150081
    China

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    Hefei, 230001
    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, 641100
    China

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    Shanghai, 201508
    China

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    Shenyang, 110001
    China

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    Shenzhen, 518053
    China

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    Shijiazhuang, 050011
    China

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    Tianjin, 300170
    China

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    Wuhan, 430079
    China

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    XI 'an, 710061
    China

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    Xi'an, 710061
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    Zhengzhou, 450008
    China

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    Zhuhai, 519000
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    Bobigny, 93000
    France

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    Bondy, 93143
    France

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    Clichy, 92210
    France

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    Grenoble cedex 9, 38043
    France

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    Lille, 59037
    France

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    Lyon Cedex 04, 69317
    France

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    Montpellier CEDEX 5, 34295
    France

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    Nice Cedex 3, 06202
    France

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    Paris, 75013
    France

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    Paris Cedex 13, 75651
    France

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    Pessac, 33604
    France

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    Poitiers, 86021
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    Toulouse Cedex 9, 31059
    France

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    Vandoeuvre Les Nancy, 54511
    France

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    Hong Kong, 999077
    Hong Kong

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    Shatin, 00000
    Hong Kong

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    Bangalore, 560068
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    Bengaluru, 560076
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    Chennai, 600035
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    Hyderabad, 500004
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    Kolkata, 700054
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    Madurai, 625107
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    Mumbai, 400 012
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    Nashik, 422002
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    Nasik, 422002
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    New Delhi, 110005
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    Pune, 411004
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    Surat, 395002
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    Vijayawada, 520002
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    Vishakhapatnam, 530017
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    Arezzo, 52100
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    Bologna, 40138
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    Brescia, 25100
    Italy

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    Milano, 20133
    Italy

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    Padova, 35128
    Italy

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    Pisa, 56124
    Italy

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    Bunkyo-ku, 113-8655
    Japan

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    Chiba-shi, 260-8677
    Japan

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    Chuo-ku, 104-0045
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    Fukuoka-shi, 810-8563
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    Hiroshima-shi, 734-8551
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    Kurume-shi, 830-0011
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    Morioka-shi, 020-8505
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    Musashino-shi, 180-8610
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    Nagoya-shi, 464-8681
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    Okayama, 700-8558
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    Osaka-shi, 534-0021
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    Osakasayama-shi, 589-8511
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    Sapporo-shi, 006-8555
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    Shiwa-gun, 028-3695
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    Tsu-shi, 514-8507
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    Yokohama-shi, 241-8515
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    Busan, 49241
    Korea, Republic of

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    Daegu, 41944
    Korea, Republic of

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    Goyang-si, 10408
    Korea, Republic of

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    Seoul, 03722
    Korea, Republic of

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    Alc. Cuauhtémoc, 06100
    Mexico

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    Culiacan, 80230
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    Guadalajara, 44280
    Mexico

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    Mexico, 14080
    Mexico

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    Mexico, Distrito Federal+52 55, 14000
    Mexico

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    Monterrey, 64710
    Mexico

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    Mérida, 97134
    Mexico

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    Tuxtla Gutierrez, 29090
    Mexico

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    Barnaul, 656049
    Russian Federation

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    Ekaterinburg, 620905
    Russian Federation

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    Kazan, 420029
    Russian Federation

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    Moscow, 115478
    Russian Federation

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    Nizhniy Novgorod, 603074
    Russian Federation

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    Novosibirsk, 630007
    Russian Federation

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    Obinsk, 249031
    Russian Federation

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    Obninsk, 249031
    Russian Federation

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    P. Herzen Moscow Oncology Rese, 125284
    Russian Federation

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    Sankt-Peterburg, 197758
    Russian Federation

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    St. Petersburg, 197758
    Russian Federation

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    Bukit Merah, 169610
    Singapore

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    Singapore, 329563
    Singapore

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    Córdoba, 14004
    Spain

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    Madrid, 28007
    Spain

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    Pamplona, 31008
    Spain

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    San Sebastián(Guipuzcoa), 20014
    Spain

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    Changhua, 500
    Taiwan

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    Kaohsiung, 833
    Taiwan

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    Liou Ying Township, 736
    Taiwan

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    Taichung, 404
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    Tainan, 704
    Taiwan

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    Tainan City, 704
    Taiwan

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    Taipei, 11217
    Taiwan

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    Taipei City, 110
    Taiwan

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    Tao Yuan, 333
    Taiwan

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    Taoyuan, 333
    Taiwan

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    Taoyuan City, 333
    Taiwan

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    Yunlin, 640
    Taiwan

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    Bangkok, 10300
    Thailand

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    Chiang Mai, 50200
    Thailand

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    Hat Yai, 90110
    Thailand

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    Khon Kaen, 40002
    Thailand

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    Phisanulok, 65000
    Thailand

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    Songkla, 90110
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    Birmingham, Alabama 35233
    United States

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    Mobile, Alabama 36604
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    Phoenix, Arizona 85054
    United States

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    Tucson, Arizona 85724
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    Costa Mesa, California 92627
    United States

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    La Jolla, California 92093-0698
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    Orange, California 92868
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    Aurora, Colorado 80045
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    Washington, District of Columbia 20007
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    Jacksonville, Florida 32224
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    Miami, Florida 33136
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    Atlanta, Georgia 30322
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    Honolulu, Hawaii 96819
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    Chicago, Illinois 60612
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    Indianapolis, Indiana 46202-5253
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    Westwood, Kansas 66205
    United States

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    New Orleans, Louisiana 70121
    United States

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    Shreveport, Louisiana 71103
    United States

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    Boston, Massachusetts 02215
    United States

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    Ann Arbor, Michigan 48197
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    Detroit, Michigan 48201
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    Rochester, Minnesota 55905-0001
    United States

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    Columbia, Missouri 65212
    United States

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    Saint Louis, Missouri 63110
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    Omaha, Nebraska 68198
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    New Brunswick, New Jersey 08903
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    New York, New York 10016
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    Stony Brook, New York 11794
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    Charlotte, North Carolina 28204
    United States

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    Durham, North Carolina 27710
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    Winston-Salem, North Carolina 27157
    United States

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    Cleveland, Ohio 44106
    United States

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    Portland, Oregon 97213
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    Philadelphia, Pennsylvania 19104
    United States

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    Pittsburgh, Pennsylvania 15212
    United States

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    Providence, Rhode Island 02903
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    Sioux Falls, South Dakota 57105
    United States

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    Knoxville, Tennessee 37920
    United States

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    Memphis, Tennessee 38104
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    Dallas, Texas 75235
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    Houston, Texas 77030
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    Murray, Utah 84107
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    Seattle, Washington 98108
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    Morgantown, West Virginia 26506
    United States

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    Milwaukee, Wisconsin 53226
    United States

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    Hanoi, 123
    Vietnam

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    Hanoi City,
    Vietnam

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    Ho Chi Minh, 700000
    Vietnam

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  • Research Site

    Ho Chi Minh City, 70000
    Vietnam

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