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 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
Study design
Primary purpose:
TREATMENT, Allocation:
RANDOMIZED, Intervention model:
PARALLEL, Masking:
QUADRUPLE, Subject masked:
Yes, Caregiver masked:
Yes, Investigator masked:
Yes, Outcomes assessor masked:
Yes,
Conditions
Hepatocellular Carcinoma
Other study ID numbers
2023-509053-32-00; 2018-002134-20; D933GC00001
Choose trial site (289)
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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) – #08-29/30 Mount Elizabeth Novena Specialist Centre
10 SINARAN DRIVE #10-27 NOVENA MEDICAL CENTRE, Singapore 307506
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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