A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
NCT ID: NCT03778957
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
724 participants
INTERVENTIONAL
2018-11-30
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A
Transarterial Chemoembolization (TACE) in combination with Durvalumab
Durvalumab
Durvalumab IV (intravenous)
Placebo
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)
Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Arm B
Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
Durvalumab
Durvalumab IV (intravenous)
Bevacizumab
Bevacizumab IV (intravenous)
Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Arm C
Transarterial Chemoembolization (TACE) in combination with Placebos
Placebo
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)
Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Interventions
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Durvalumab
Durvalumab IV (intravenous)
Bevacizumab
Bevacizumab IV (intravenous)
Placebo
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)
Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
110 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bruno Sangro, MD
Role: PRINCIPAL_INVESTIGATOR
Clinica Universidad de Navarra
Riccardo Lencioni, MD FSIR EBIR
Role: PRINCIPAL_INVESTIGATOR
University of Pisa / Miami Cancer Institute
Locations
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Research Site
Costa Mesa, California, United States
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La Jolla, California, United States
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Orange, California, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Shreveport, Louisiana, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Stony Brook, New York, United States
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Charlotte, North Carolina, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Sioux Falls, South Dakota, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Milwaukee, Wisconsin, United States
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Benowa, , Australia
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Box Hill, , Australia
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Camperdown, , Australia
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Clayton, , Australia
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Herston, , Australia
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Liverpool, , Australia
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Melbourne, , Australia
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Barretos, , Brazil
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Florianópolis, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Santa Maria, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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Vitória, , Brazil
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Chengdu, , China
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Fuzhou, , China
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Fuzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Harbin, , China
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Hefei, , China
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Nanchang, , China
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Nanjing, , China
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Nanjing, , China
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Nantong, , China
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Neijiang, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Shenzhen, , China
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Tianjin, , China
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Wuhan, , China
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Wuhan, , China
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Xi'an, , China
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Zhengzhou, , China
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Zhuhai, , China
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Bobigny, , France
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Clichy, , France
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Grenoble, , France
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Montpellier, , France
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Nice, , France
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Paris, , France
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Pessac, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Hong Kong, , Hong Kong
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Shatin, , Hong Kong
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Bangalore, , India
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Bengaluru, , India
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Hyderabad, , India
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Kolkata, , India
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Kolkata, , India
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Madurai, , India
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Mumbai, , India
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Nashik, , India
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Pune, , India
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Surat, , India
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Vijayawada, , India
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Visakhapatnam, , India
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Arezzo, , Italy
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Brescia, , Italy
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Milan, , Italy
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Milan, , Italy
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Pisa, , Italy
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Bunkyō City, , Japan
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Chiba, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Hiroshima, , Japan
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Kurume-shi, , Japan
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Musashino-shi, , Japan
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Nagoya, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Sapporo, , Japan
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Shiwa-gun, , Japan
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Tsu, , Japan
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Yokohama, , Japan
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Alc. Cuauhtémoc, , Mexico
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Culiacán, , Mexico
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Guadalajara, , Mexico
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Mérida, , Mexico
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México, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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Tuxtla Gutiérrez, , Mexico
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Barnaul, , Russia
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Kazan', , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Obninsk, , Russia
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Saint Petersburg, , Russia
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Yekaterinburg, , Russia
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Singapore, , Singapore
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Busan, , South Korea
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Daegu, , South Korea
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Goyang-si, , South Korea
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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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Córdoba, , Spain
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Madrid, , Spain
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Pamplona, , Spain
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San Sebastián(Guipuzcoa), , Spain
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Kaohsiung City, , Taiwan
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Liou Ying Township, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Hat Yai, , Thailand
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Khon Kaen, , Thailand
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Phisanulok, , Thailand
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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References
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Sangro B, Kudo M, Erinjeri JP, Qin S, Ren Z, Chan SL, Arai Y, Heo J, Mai A, Escobar J, Lopez Chuken YA, Yoon JH, Tak WY, Breder VV, Suttichaimongkol T, Bouattour M, Lin SM, Peron JM, Nguyen QT, Yan L, Chiu CF, Santos FA, Veluvolu A, Thungappa SC, Matos M, Zotkiewicz M, Udoye SI, Kurland JF, Cohen GJ, Lencioni R; EMERALD-1 Investigators. Durvalumab with or without bevacizumab with transarterial chemoembolisation in hepatocellular carcinoma (EMERALD-1): a multiregional, randomised, double-blind, placebo-controlled, phase 3 study. Lancet. 2025 Jan 18;405(10474):216-232. doi: 10.1016/S0140-6736(24)02551-0. Epub 2025 Jan 8.
Kloeckner R, Galle PR, Bruix J. Local and Regional Therapies for Hepatocellular Carcinoma. Hepatology. 2021 Jan;73 Suppl 1:137-149. doi: 10.1002/hep.31424. Epub 2020 Nov 6. No abstract available.
Other Identifiers
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2023-509053-32-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-002134-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D933GC00001
Identifier Type: -
Identifier Source: org_study_id
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