A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
- Trial number:
- NCT03778957
- Trial phase:
- 3
- Study type:
- Immunotherapy, Targeted therapy, Local/Regional therapies
- Overall status:
- Active, not recruiting
Study start date
November, 2018
Scientific title
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination With Either Durvalumab Monotherapy or Durvalumab Plus Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1)
Summary
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma
Key
No evidence of extrahepatic diseaseDisease 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
Study design
Primary purpose:
Treatment, Allocation:
Randomized, Intervention model:
Parallel Assignment, Masking:
Quadruple, Subject masked:
Yes, Caregiver masked:
Yes, Investigator masked:
Yes, Outcomes assessor masked:
Yes,
Conditions
Hepatocellular Carcinoma
Other study ID numbers
D933GC00001; 2018-002134-20
Choose trial site (244)
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2155 Rue Guy, Montréal, QC H3H 2L9, Canada
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Shenyang, Liaoning, China
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1001 Boulevard Décarie, Montréal, QC H4A 3J1, Canada
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Shenzhen, Guangdong Province, China
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Beijing, China
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China, Shang Hai Shi, Xu Hui Qu, 平福路188号漕河泾聚鑫园4号楼2层
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439 Chunxiao Rd, Pu Dong Xin Qu, Shang Hai Shi, China, 201203
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1601 Center St, Mobile, AL 36604, USA
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Phoenix, AZ 85054, USA
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Tucson, AZ 85719, USA
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275 Victoria St, Costa Mesa, CA 92627, USA
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La Jolla, CA 92093, USA
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1010 W Chapman Ave, Orange, CA 92868, USA
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12800 E 17th Ave, Aurora, CO 80045, USA
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1000 Thomas Jefferson St NW #200, Washington, DC 20007, USA
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4500 San Pablo Road, Jacksonville, FL 32224, USA
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1120 NW 14th St, Miami, FL 33136, USA
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8955 SW 87th Ct, Miami, FL 33176, USA
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China, Shang Hai Shi, Xu Hui Qu, 平福路188号漕河泾聚鑫园4号楼2层
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3375 Koapaka Street, I-540, Honolulu, HI 96819, USA
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909 S Wolcott Ave, Chicago, IL 60612, USA
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Indianapolis, IN 46202, USA
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2650 Shawnee Mission Pkwy, Westwood, KS 66205, USA
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1535 Irving Pl, Shreveport, LA 71101, USA
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Boston, MA 02114, USA
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Boston, MA 02215, USA
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3600 Green Ct STE 100, Ann Arbor, MI 48105, USA
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4100 John R St, Detroit, MI 48201, USA
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Rochester, MN 55905, USA
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4939 Childrens Pl, St. Louis, MO 63110, USA
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985950 Nebraska Medical Ctr, Omaha, NE 68198, USA
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100 Nicolls Rd, Stony Brook, NY 11794, USA
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Charlotte, NC 28204, USA
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Durham, NC 27710, USA
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1901 S Hawthorne Rd #306, Winston-Salem, NC 27103, USA
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9620 Carnegie Ave n building, Cleveland, OH 44106, USA
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5211 NE Glisan St, Portland, OR 97213, USA
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3535 Market St #500, Philadelphia, PA 19104, USA
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Pittsburgh, PA 15212, USA
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1016 W 18th St, Sioux Falls, SD 57104, USA
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1928 Alcoa Hwy, Knoxville, TN 37920, USA
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44 S Cleveland St, Memphis, TN 38104, USA
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4500 S Lancaster Rd, Dallas, TX 75216, USA
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1341 W Mockingbird Ln #400, Dallas, TX 75247, USA
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5323 Harry Hines Blvd, Dallas, TX 75390, USA
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6670 Bertner Ave, Houston, TX 77030, USA
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Houston, TX 77090, USA
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886 Chestnut Ridge Rd, Morgantown, WV 26505, USA
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Milwaukee, WI, USA
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Benowa QLD 4217, Australia
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116/118 Thames St, Box Hill VIC 3128, Australia
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Royal Prince Alfred Hospital, Missenden Rd, Sydney NSW 2050, Australia
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Research Way, Clayton VIC 3168, Australia
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Level 3, Building 71/918, Royal Brisbane & Women's Hospital, Herston QLD 4029, Australia
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1 Campbell St, Liverpool NSW 2170, Australia
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85 Commercial Rd, Melbourne VIC 3004, Australia
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176 Hawkesbury Rd, Westmead NSW 2145, Australia
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R. Antenor Duarte Viléla, 1301-2147483647 - Dr. Paulo Prata, Barretos - SP, 14784-400, Brazil
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Rod. Admar Gonzaga, 1-2025 - Itacorubi, Florianópolis - SC, 88034-000, Brazil
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R. Sarmento Leite, 245 - Centro Histórico, Porto Alegre - RS, 90050-170, Brazil
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R. Ramiro Barcelos, 2350 - Rio Branco, Porto Alegre - RS, 90035-007, Brazil
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Rua Doutor João Satt, 25, 1802 - Torre B - Vila Ipiranga, Porto Alegre - RS, 91360-394, Brazil
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R. André Cavalcanti, 37 - Centro, Rio de Janeiro - RJ, 20231-050, Brazil
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R. Justino Couto, 179 - Duque de Caxias, Santa Maria - RS, 97070-500, Brazil
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Av. Paulista, 1499 - Bela Vista, São Paulo - SP, 01310-200, Brazil
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São Paulo, State of São Paulo, Brazil
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Av. Brg. Faria Lima, 5544 - Jardim Panorama, São José do Rio Preto - SP, 15020, Brazil
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Av. Maruípe, 372-816 - Santa Cecilia, Vitória - ES, 29043-272, Brazil
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699 Concession St, Hamilton, ON L8V 5C2, Canada
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501 Smyth Rd, Ottawa, ON K1H 8L6, Canada
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2075 Bayview Ave, Toronto, ON M4N 3M5, Canada
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661 University Ave Suite 510, Toronto, ON M5G 0A3, Canada
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China, Bei Jing Shi, Hai Dian Qu, 西八里庄路恩济庄96号院 邮政编码: 100036
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Beijing, China
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52 Sanlihe Rd, Xi Cheng Qu, Bei Jing Shi, China
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China, Ji Lin Sheng, Chang Chun Shi, Chao Yang Qu, 解放大路2519号 邮政编码: 130021
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China, Hu Nan Sheng, Chang Sha Shi, Yue Lu Qu, 银杉路327号 邮政编码: 410013
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China, Si Chuan Sheng, Cheng Du Shi, Cheng Hua Qu, 熊猫大道1375号 邮政编码: 610016
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China, Fu Jian Sheng, Fu Zhou Shi, Tai Jiang Qu, 南门商圈仁德路
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China, Fu Jian Sheng, Fu Zhou Shi, Gu Lou Qu, 环西湖商圈梦山路85号
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80 Xianlie Middle Rd, Yue Xiu Qu, Guang Zhou Shi, Guang Dong Sheng, China
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Guangzhou, Guangdong Province, China
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China, Guang Dong Sheng, Guang Zhou Shi, Bai Yun Qu, 广州大道北1838号
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China, Zhe Jiang Sheng, Hang Zhou Shi, Xia Cheng Qu, 文青弄西湖文化广场6
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China, Zhe Jiang Sheng, Hang Zhou Shi, Xia Cheng Qu, 华丰路
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Harbin, Heilongjiang, China
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Hefei, Anhui, China
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90 Fuzhou Rd, Dong Hu Qu, Nan Chang Shi, Jiang Xi Sheng, China, 330006
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8600 Rockville Pike, Bethesda, MD 20894, USA
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Nanjing, Jiangsu, China
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204 Guo Dao, Tong Zhou Qu, Nan Tong Shi, Jiang Su Sheng, China
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Neijiang, Sichuan, China
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China, Shang Hai Shi, Xu Hui Qu, 平福路188号漕河泾聚鑫园4号楼2层
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China, He Bei Sheng, Shi Jia Zhuang Shi, Chang An Qu, 育才街
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Tianjin, China
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China, Hu Bei Sheng, Wu Han Shi, Jiang An Qu, 解放大道2273号
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Wuhan, Hubei, China
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Qujiang Shangquan, Yanta District, Xi'an, China, 710061
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Zhengzhou, Henan, China
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Zhuhai, Guangdong Province, China
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34 Rue Saint-André, 93000 Bobigny, France
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Clichy, France
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Grenoble, France
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Lille, France
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Montpellier, France
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Rd 6202 Quartier, 06201 Nice, France
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Paris, France
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33600 Pessac, France
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Entrée 5 - Cours Est Jean Bernard CHU de Poitiers 2 rue de la Miletrie, 86000 Poitiers, France
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Toulouse, France
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54500 Vandœuvre-lès-Nancy, France
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9/F & 10/F, Department of Economics, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong, Ma Liu Shui, Hong Kong
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Sha Tin, Hong Kong
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199/1, 2nd cross, Jakkasandra extension, 1st Block Koramangala, Koramangala, Bengaluru, Karnataka 560034, India
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No.640, Janardhana Towers, B Block, 3rd Floor, Bilekahalli, Bannerghatta Road, Ranka Colony, Bilekahalli, Bengaluru, Karnataka 560076, India
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# 8-2-596/2, 2nd Floor, Opp: Karvy, Banjara hills Road No 10,, Hyderabad, Telangana. India. Pin : 500004., Gaffar Khan Colony, Banjara Hills, Hyderabad, Telangana 500004, India
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P-26, CIT Rd, opp. Pantaloons, Scheme VI-M, Kadapara, Phool Bagan, Kankurgachi, Kolkata, West Bengal 700054, India
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14, MAR(E-W), DH Block(Newtown), Action Area I, Newtown, Kolkata, West Bengal 700160, India
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Lake Area, Melur Main Rd, Madurai, Tamil Nadu 625107, India
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J Merwanji St, Parel East, Parel, Mumbai, Maharashtra 400012, India
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Kale Donia Building, Sahar Rd, Sambhaji Nagar, Mhada Colony, Andheri East, Mumbai, Maharashtra 400058, India
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Kulkarni Colony, Near Kulkarni Garden, Sharanpur Rd, opposite Soni Paithani sarees, Racca Colony, Sharanpur, Nashik, Maharashtra 422002, India
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33/34 B, Makarand Bhave Path, Karve Rd, Abhiman Society, Kachare Colony, Erandwane, Pune, Maharashtra 411004, India
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2/1362, "Bhumi House", Sagrampura, Opp. Sub-Jail, Ring Road Opp JK Tower, Sagrampura, Surat, Gujarat 395002, India
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Vijayawada Rd, Krishnalanka, Vijayawada, Andhra Pradesh 520002, India
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Plot No:1, Sector:7, MVP Colony, Visakhapatnam, Andhra Pradesh 530017, India
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52100 Arezzo, Province of Arezzo, Italy
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Via S. Giacomo, 9/2, 40126 Bologna BO, Italy
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25100 Manerbio, Province of Brescia, Italy
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Via Olgettina, 58, 20132 Milano MI, Italy
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Via Giovanni Pascoli, 70, 20133 Milano MI, Italy
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Via Leonardo Loredan, 18, 35131 Padova PD, Italy
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Via Giuseppe Moruzzi, 1, 56124 Pisa PI, Italy
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2-chōme-11-16 Yayoi, Bunkyo City, Tokyo 113-8656, Japan
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1-chōme-8-1 Inohana, Chuo Ward, Chiba, 260-8677, Japan
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5-chōme-1-1 Tsukiji, Chuo City, Tokyo 104-0045, Japan
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2-chōme-1-34 Jigyōhama, Chuo Ward, Fukuoka, 810-0065, Japan
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Hiroshima, Japan
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830-0011, Japan
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Morioka, Iwate, Japan
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3-chōme-9-11 Midorichō, Musashino, Tokyo 180-8585, Japan
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Furocho, Chikusa Ward, Nagoya, Aichi 464-8601, Japan
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700-8558, Japan
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3-3-1 Yamadaoka, Suita, Osaka 565-0871, Japan
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545-8586, Japan
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Japan, 〒589-0014 Osaka, Osakasayama, Ōnohigashi, 377−2 研究棟 I
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10 Chome Kita 15 Jonishi, Kita Ward, Sapporo, Hokkaido 001-0015, Japan
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514-8507, Japan
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2-chōme-3-2 Nakao, Asahi Ward, Yokohama, Kanagawa 241-8515, Japan
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Busan, South Korea
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Daegu, South Korea
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Goyang-si, Gyeonggi-do, 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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Seoul, South Korea
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Hipódromo, 06100 Ciudad de México, CDMX, Mexico
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Avenida Jesús Andrade S/N, Miguel Alemán, 80200 Culiacán Rosales, Sin., Mexico
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Centro Barranquitas, 44280 Guadalajara, Jal., Mexico
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Mexico City, CDMX, Mexico
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Miguel Hidalgo 75, Niño Jesús, Tlalpan, 14080 Ciudad de México, CDMX, Mexico
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64460, Dr. Eduardo Aguirre Pequeño 901-C, Mitras Centro, 64460 Monterrey, N.L., Mexico
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Del Hospital 2538, Sertoma, 64718 Monterrey, N.L., Mexico
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C. 25 235, Montecarlo, Sin Nombre de Col 26, 97130 Mérida, Yuc., Mexico
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Calz. Cerro Hueco s/n, El Zapotal, 29094 Tuxtla Gutiérrez, Chis., Mexico
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Prospekt Lenina, 61, Barnaul, Altayskiy kray, Russia, 656049
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Ulitsa Akademika Arbuzova, 8, Kazan, Respublika Tatarstan, Russia, 420029
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Kashira Hwy, 23, Moskva, Russia, 115478
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Ulitsa Oktyabr'skaya, 25, Nizhnij Novgorod, Nizhegorodskaya oblast', Russia, 603005
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Ulitsa Fabrichnaya, 2, офис 21, Novosibirsk, Novosibirskaya oblast', Russia, 630007
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Ulitsa Zhukova, 10, Obninsk, Kaluzhskaya oblast', Russia, 249031
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University Embankment, 7-9, Sankt-Peterburg, Russia, 199034
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Griboyedov channel embankment, 123, Room 123, Sankt-Peterburg, Russia, 190068
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11 Hospital Cres, Singapore 169610
National University Hospital 119228
1 Create Way, Singapore 138602
Curie Oncology (Novena)
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Hospital Universitario Reina Sofía, Edificio IMIBIC, Av. Menéndez Pidal, s/n, 14004 Córdoba, Spain
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C. del Pez Volador, 5, 28007 Madrid, Spain
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Av. de Pío XII, 55, 31008 Pamplona, Navarra, Spain
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Mikeletegi Pasealekua, 69, 20009 Donostia, Gipuzkoa, Spain
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No. 235, Xuguang Rd, Changhua City, Changhua County, Taiwan 500
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No. 823號, Chengqing Rd, Niaosong District, Kaohsiung City, Taiwan 833
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Liuying District, Tainan City, Taiwan 736
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Business Building, No. 100號, Wenhua Rd, Xitun District, Taichung City, Taiwan 407
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Taichung, North District, Taichung City, Taiwan
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Tainan City, Taiwan
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4F, No.200, Sec.1 Keelung Road, 信義區台北市 Taiwan 110
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Taipei City, Taiwan
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Taipei City, Taiwan
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Guishan District, Taoyuan City, Taiwan 333
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Yunlin County, Taiwan
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50 ซอย จักรพันธุ์ Khwaeng Lat Yao, Khet Chatuchak, Krung Thep Maha Nakhon 10900, Thailand
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272 Thanon Rama VI, Khwaeng Thung Phaya Thai, Khet Ratchathewi, Krung Thep Maha Nakhon 10400, Thailand
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หน่วยวิจัยทางคลินิก (Clinical Research Center) ห้อง 310 ชั้น 3, สำนักงานวิจัยวิชาการและนวัตกรรม คณะแพทยศาสตร์ โรงพยาบาลรามาธิบดี, ถนน พระรามที่ ๖ แขวง ทุ่งพญาไท เขตราชเทวี กรุงเทพมหานคร 10400, Thailand
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155 Mae Hia, Amphoe Mueang Chiang Mai, Chang Wat Chiang Mai 50100, Thailand
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Khon Kaen, Mueang Khon Kaen District, Khon Kaen 40000, Thailand
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R6M3+8CP, Ban Krang, Mueang Phitsanulok District, Phitsanulok 65000, Thailand
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15 ถนนกาญจนวนิช Kho Hong, Amphoe Hat Yai, Chang Wat Songkhla 90110, Thailand
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Hanoi, Hoàn Kiếm, Hanoi, Vietnam
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Lý Thường Kiệt, Cửa Nam, Hoàn Kiếm, Hà Nội, Vietnam
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36 Street 01, Mizuki Park Nam, Phường 9, Hồ Chí Minh, Thành phố Hồ Chí Minh 70000, Vietnam
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224 Điện Biên Phủ, Võ Thị Sáu, Quận 3, Thành phố Hồ Chí Minh 70000, Vietnam
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Av. Paulista, 1499 - Bela Vista, São Paulo - SP, 01310-200, Brazil
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Av. Nove de Julho, 5109 - 8° andar - Itaim Bibi, São Paulo - SP, 01406-200, Brazil
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12 B /2, MODEL HOUSE ROAD, C.I.T. NAGAR, CIT Nagar East, CIT Nagar, Chennai, Tamil Nadu 600035, India
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877, E Park Rd, opp. Ajmal Khan Park, Block A, Karol Bagh, New Delhi, Delhi 110005, India
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B- 1/1073, Vasant Kunj, Sector B Rd, Pocket 1, Sector B, Vasant Kunj, New Delhi, Delhi 110011, India
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Yekaterinburg, Sverdlovsk Oblast, Russia
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1819 E 101st St, Cleveland, OH 44106, USA
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1719 6th Ave S, Birmingham, AL 35233, USA
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2040 Ridgewood Dr NE, Atlanta, GA 30322, USA
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1401-A, Jefferson Hwy, Jefferson, LA 70121, USA
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3217 Mabel St, Shreveport, LA 71103, USA
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134 Research Park Dr, Columbia, MO 65211, USA
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104 Bayard St, New Brunswick, NJ 08901, USA
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430 E 29th St, New York, NY 10016, USA
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333 Cottman Ave, Philadelphia, PA 19111, USA
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3517 N Carlisle St, Philadelphia, PA 19140, USA
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200 Lothrop St, Pittsburgh, PA 15213, USA
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1 Hoppin St #204, Providence, RI 02903, USA
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5131 S Cottonwood St, Murray, UT 84107, USA
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6737 Corson Ave S, Seattle, WA 98108, USA
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China, Zhe Jiang Sheng, Hang Zhou Shi, Shang Cheng Qu, 中山中路317号-1
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China, Shan Xi Sheng, Xi An Shi, Yan Ta Qu, 雁翔路99号
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Lyon, France
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Shosse Entuziastov, 46, Moskva, Russia, 111123
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Moscow, Russia, 125284
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Hanoi, Hoàn Kiếm, Hanoi, Vietnam
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1044 W Walnut St, Indianapolis, IN 46202, USA
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10437 W Innovation Dr # 123, Milwaukee, WI 53226, USA
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9/F & 10/F, Department of Economics, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong, Ma Liu Shui, Hong Kong
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028-3695, Japan
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Ulitsa Zhukova, 10, Obninsk, Kaluzhskaya oblast', Russia, 249031
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อาคารบริหารวิชาการรวม ชั้น 5 มหาวิทยาลัยสงขลานครินทร์ Tambon Kho Hong, Amphoe Hat Yai, Chang Wat Songkhla 90110, Thailand
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5230 Centre Ave, Pittsburgh, PA 15232, USA
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9 Princes St, Fitzroy VIC 3065, Australia
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Liberdade, São Paulo - State of São Paulo, 01509, Brazil
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China, Bei Jing Shi, Chao Yang Qu, 小营路13号 邮政编码: 100101
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Guishan District, Taoyuan City, Taiwan 333
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Hanoi, Hoàn Kiếm, Hanoi, Vietnam
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1277 Jiefang Blvd, 西北湖 Jiang Han Qu, Wu Han Shi, Hu Bei Sheng, China, 430000
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Nashik, Maharashtra 422002, India