New combo therapy shows promise in battle against advanced liver cancer
NCT ID NCT04039607
First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times
Summary
This study tests whether a combination of two immunotherapy drugs (nivolumab and ipilimumab) can help people with advanced liver cancer live longer than current standard treatments. About 732 participants who have not had prior systemic therapy will be randomly assigned to receive either the new combination or standard drugs (sorafenib or lenvatinib). The main goal is to compare overall survival between the groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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732 people
The number who actually took part.
- Started
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Sep 2019
- Finished
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Jul 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must have a diagnosis of HCC based on histological confirmation * Participants must have an advanced HCC * Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion * Child-Pugh score 5 or 6 * Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1 Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * Prior liver transplant * Episodes of hepatic encephalopathy (greater than or equal to \[\>=\] Grade 2) within 12 months prior to randomization * Active brain metastases or leptomeningeal metastases Other protocol-defined inclusion/exclusion criteria apply.
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
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Local Institution
Ann Arbor, Michigan, 48105, United States
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Local Institution
Salvador, Estado de Bahia, 41253190, Brazil
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Local Institution
Brno, 60200, Czechia
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Local Institution
Marseille, 13009, France
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Local Institution
München, 81675, Germany
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Local Institution
Craiova, 200385, Romania
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Local Institution - 0001
Melbourne, Victoria, 3004, Australia
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Local Institution - 0002
Westmead, New South Wales, 2145, Australia
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Local Institution - 0003
Kogarah, New South Wales, 2217, Australia
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Local Institution - 0004
Birtinya, Queensland, 4560, Australia
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Local Institution - 0005
Frankfurt am Main, Hesse, 60590, Germany
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Local Institution - 0006
Hamburg, 20246, Germany
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Local Institution - 0007
Moscow, 115478, Russia
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Local Institution - 0008
Federal District, 72115700, Belgium
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Local Institution - 0009
Adelaide, South Australia, 5000, Australia
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Local Institution - 0012
Viña del Mar, Valparaiso, 2520598, Chile
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Local Institution - 0013
Herston, Queensland, 4029, Australia
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Local Institution - 0015
Rio de Janeiro, 22793-080, Brazil
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Local Institution - 0016
Paranã, 81520-060, Brazil
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Local Institution - 0017
Singapore, 258499, Singapore
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Local Institution - 0018
Detroit, Michigan, 48202, United States
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Local Institution - 0019
Clayton, Victoria, 3168, Australia
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Local Institution - 0020
St Albans, Victoria, 3021, Australia
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Local Institution - 0022
São Paulo, 01323-900, Brazil
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Local Institution - 0023
São Paulo, 01246-000, Brazil
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Local Institution - 0024
Santiago, Santiago Metropolitan, 7710007, Chile
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Local Institution - 0025
Pessac, 33604, France
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Local Institution - 0026
Fitzroy, Victoria, 3065, Australia
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Local Institution - 0027
Louisville, Kentucky, 40217, United States
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Local Institution - 0028
Cologne, 50937, Germany
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Local Institution - 0029
Arkhangelsk, 163045, Russia
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Local Institution - 0031
Mainz, 55131, Germany
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Local Institution - 0032
Hong Kong, Hong Kong
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Local Institution - 0033
Parma, 43126, Italy
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Local Institution - 0034
Brussels, 1070, Belgium
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Local Institution - 0035
San Juan, 00927-4308, Puerto Rico
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Local Institution - 0036
Hong Kong, 999077, Hong Kong
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Local Institution - 0037
Caba, Buenos Aires, C1090AAS, Argentina
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Local Institution - 0038
Liverpool, New South Wales, 1871, Australia
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Local Institution - 0039
Milan, 20122, Italy
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Local Institution - 0040
Zaragoza, 50009, Spain
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Local Institution - 0041
Madrid, 28007, Spain
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Local Institution - 0042
Toulouse, 31059, France
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Local Institution - 0043
Toledo, Ohio, 43623, United States
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Local Institution - 0044
Vicenza, 36100, Italy
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Local Institution - 0045
Majadahonda, 28222, Spain
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Local Institution - 0046
Lubbock, Texas, 79410, United States
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Local Institution - 0047
Auckland, 1023, New Zealand
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Local Institution - 0048
Singapore, 168583, Singapore
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Local Institution - 0049
Otwock, 05-400, Poland
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Local Institution - 0050
São Paulo, 04038-034, Brazil
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Local Institution - 0051
Villejuif, 94800, France
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Local Institution - 0052
Essen, 45147, Germany
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Local Institution - 0053
North Rhine-Westphalia, 45136, Germany
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Local Institution - 0054
Jaú, São Paulo, 17210-120, Brazil
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Local Institution - 0055
Barcelona, 08036, Spain
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Local Institution - 0056
Mannheim, 68167, Germany
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Local Institution - 0057
Wiener Neustadt, Lower Austria, 2700, Austria
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Local Institution - 0058
San Miguel de Tucumán, 4000, Argentina
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Local Institution - 0059
Changsha, Hunan, 410011, China
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Local Institution - 0060
Pelotas, Rio Grande do Sul, 96020-360, Brazil
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Local Institution - 0061
Salvador, Estado de Bahia, 41950-640, Brazil
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Local Institution - 0062
Jongno-gu, Seoul, 03080, South Korea
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Local Institution - 0063
Bern, 3010, Switzerland
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Local Institution - 0064
Leuven, 3000, Belgium
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Local Institution - 0065
Klagenfurt, 9020, Austria
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Local Institution - 0066
Barnaul, 656045, Russia
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Local Institution - 0067
Nice, 6202, France
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Local Institution - 0068
Amiens, 80054, France
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Local Institution - 0069
Clichy, 92110, France
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Local Institution - 0070
Lyon, 69004, France
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Local Institution - 0071
Vandœuvre-lès-Nancy, 54500, France
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Local Institution - 0072
Pyatigorsk, 357502, Russia
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Local Institution - 0073
Sochi, 354057, Russia
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Local Institution - 0074
Chelyabinsk, 454087, Russia
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Local Institution - 0075
Saint Petersburg, 197758, Russia
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Local Institution - 0077
Washington D.C., District of Columbia, 20007, United States
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Local Institution - 0078
Taipei, 11266, Taiwan
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Local Institution - 0079
Rome, 00168, Italy
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Local Institution - 0081
Grenoble, 38043, France
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Local Institution - 0082
Montpellier, 34295, France
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Local Institution - 0084
Candiolo, 10060, Italy
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Local Institution - 0085
Pamplona, 31008, Spain
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Local Institution - 0087
El Palmar, 30120, Spain
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Local Institution - 0088
Santander, 39008, Spain
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Local Institution - 0089
Barcelona, 08908, Spain
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Local Institution - 0090
Córdoba, 14004, Spain
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Local Institution - 0091
Saint Petersburg, 198255, Russia
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Local Institution - 0092
Warsaw, 02-034, Poland
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Local Institution - 0093
Madrid, 28028, Spain
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Local Institution - 0094
La Serena, Coquimbo Region, 1720430, Chile
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Local Institution - 0095
Santiago, Santiago Metropolitan, 0, Chile
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Local Institution - 0096
Kaohsiung City, 83301, Taiwan
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Local Institution - 0097
Gyeonggi-do, 010408, South Korea
-
Local Institution - 0098
Gyeongsangnam-do, 050612, South Korea
-
Local Institution - 0099
Haine-Saint-Paul, 7100, Belgium
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Local Institution - 0100
Novara, 28100, Italy
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Local Institution - 0101
Rozzano, Milano, 20089, Italy
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Local Institution - 0102
Hanover, 30625, Germany
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Local Institution - 0103
Craiova, Dolj, 200542, Romania
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Local Institution - 0104
Liège, 4000, Belgium
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Local Institution - 0105
Taichung, 40447, Taiwan
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Local Institution - 0107
Hangzhou, Zhejiang, 310022, China
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Local Institution - 0108
Hangzhou, Zhejiang, 310000, China
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Local Institution - 0109
Changsha, Hunan, 410006, China
-
Local Institution - 0110
Meldola, Forli-Cesena, 47014, Italy
-
Local Institution - 0111
Siena, 53100, Italy
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Local Institution - 0112
Roma, 00128, Italy
-
Local Institution - 0114
Sankt Pölten, Lower Austria, 3100, Austria
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Local Institution - 0116
Caen, 14033, France
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Local Institution - 0118
Leipzig, 04103, Germany
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Local Institution - 0120
Hefei, Anhui, 230022, China
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Local Institution - 0121
Fuzhou, Fujian, 350014, China
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Local Institution - 0122
Minato-ku, Tokyo, 105-8470, Japan
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Local Institution - 0123
Shenyang, Liaoning, 110004, China
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Local Institution - 0124
Ghent, 9000, Belgium
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Local Institution - 0125
Guangzhou, Guangdong, 510000, China
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Local Institution - 0127
Sayama, Osaka, 5898511, Japan
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Local Institution - 0128
Minato, Tokyo, 105-8470, Japan
-
Local Institution - 0129
London, SE5 9RS, United Kingdom
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Local Institution - 0130
Nanjing, Jiangsu, 210002, China
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Local Institution - 0131
Dalian, Liaoning, 116023, China
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Local Institution - 0132
Shenyang, Liaoning, 110117, China
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Local Institution - 0133
Xi'an, Shaanxi, 710038, China
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Local Institution - 0134
Shanghai, Shanghai Municipality, 200032, China
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Local Institution - 0135
Harbin, Heilongjiang, 150081, China
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Local Institution - 0136
Buenos Aires, C1426ANZ, Argentina
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Local Institution - 0137
Poitiers, 86021, France
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Local Institution - 0138
Dijon, 21000, France
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Local Institution - 0139
Seoul, 06351, South Korea
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Local Institution - 0140
Seoul, 05505, South Korea
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Local Institution - 0141
Seoul, 03722, South Korea
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Local Institution - 0142
Busan, 49241, South Korea
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Local Institution - 0143
Seongnam-si, Gyeonggi-do, 13496, South Korea
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Local Institution - 0144
Taipei, 10002, Taiwan
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Local Institution - 0145
Nanchang, Jiangxi, 330006, China
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Local Institution - 0146
Hefei, Anhui, 230601, China
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Local Institution - 0147
Xi'an, Shan3xi, 710061, China
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Local Institution - 0148
Gdansk, 80219, Poland
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Local Institution - 0149
Nanchang, Jiangxi, 330019, China
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Local Institution - 0150
Guangzhou, Guangdong, 510515, China
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Local Institution - 0151
Fuzhou, Fujian, 350002, China
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Local Institution - 0152
Beijing, Beijing Municipality, 100142, China
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Local Institution - 0153
Qingdao, Shandong, 266000, China
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Local Institution - 0154
Guildford, Surrey, GU2 7XX, United Kingdom
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Local Institution - 0155
Sapporo, 0600033, Japan
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Local Institution - 0156
Santiago, Santiago Metropolitan, 8380456, Chile
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Local Institution - 0157
Duarte, California, 91010-3012, United States
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Local Institution - 0160
Edinburgh, EH4 2XU, United Kingdom
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Local Institution - 0162
Changchun, Jilin, 130021, China
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Local Institution - 0163
Timișoara, 300166, Romania
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Local Institution - 0164
Bucharest, 022328, Romania
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Local Institution - 0165
Cluj-Napoca, 400015, Romania
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Local Institution - 0166
Changchun, Jilin, 130102, China
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Local Institution - 0167
Guro-gu, Seoul, 8308, South Korea
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Local Institution - 0168
Tainan, 704, Taiwan
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Local Institution - 0171
London, Greater London, W12 OHS, United Kingdom
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Local Institution - 0172
Salt Lake City, Utah, 84106, United States
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Local Institution - 0173
Taoyuan, 333, Taiwan
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Local Institution - 0174
Singapore, 308442, Singapore
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Local Institution - 0175
Beijing, Beijing Municipality, 100000, China
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Local Institution - 0176
Kanazawa, Ishikawa-ken, 920-8641, Japan
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Local Institution - 0177
Hiroshima, 7348551, Japan
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Local Institution - 0178
Fukuoka, 830-0011, Japan
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Local Institution - 0179
Chongqing, Sichuan, 400030, China
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Local Institution - 0181
Brasília, Federal District, 70200-730, Brazil
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Local Institution - 0185
Freiburg im Breisgau, 79106, Germany
-
Local Institution - 0186
Vienna, 1090, Austria
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Local Institution - 0188
Graz, 8036, Austria
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Local Institution - 0189
Kyoto, Kyoto, 602-8566, Japan
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Local Institution - 0190
Baltimore, Maryland, 21287, United States
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Local Institution - 0192
Edmonton, Alberta, T6G 1Z2, Canada
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Local Institution - 0193
Kashiwa-shi, Chiba, 2778577, Japan
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Local Institution - 0194
Pilar, Buenos Aires, B1629ODT, Argentina
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Local Institution - 0199
Musashino-shi, Tokyo, 180-8610, Japan
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Local Institution - 0200
Yokohama, Kanagawa, 2320024, Japan
-
Local Institution - 0201
Mitaka, Tokyo, 181-8611, Japan
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Local Institution - 0202
Houston, Texas, 77030, United States
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Local Institution - 0203
Matsuyama, Ehime, 790-0024, Japan
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Local Institution - 0204
Chiba, 260-8677, Japan
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Local Institution - 0216
Viña del Mar, Valparaiso, 2540402, Chile
-
Local Institution - 0219
Padova, 35128, Italy
-
Local Institution - 0231
Bonn, 53127, Germany
-
Local Institution - 0258
Iruma-gun, Saitama, 3500495, Japan
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Local Institution - 0259
Izunokuni-shi, Shizuoka, 410-2295, Japan
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Local Institution - 0261
Kashihara, Nara, 634-8522, Japan
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Local Institution - 0262
Yokohama, Kanagawa, 241-8515, Japan
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Local Institution - 0263
Abeno-ku, Osaka, 5458586, Japan
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Local Institution - 0270
Tainan, 736, Taiwan
-
Local Institution - 0271
Taichung, 40705, Taiwan
-
Local Institution - 0272
Kaohsiung City, 807, Taiwan
-
Local Institution - 0274
Prague, Prague, 14059, Czechia
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Local Institution - 0278
Vitória, Espírito Santo, 29055-450, Brazil
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Local Institution - 0279
Ijuí, Rio Grande do Sul, 98700-000, Brazil
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Local Institution - 0281
Saga, Saga-ken, 8408571, Japan
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Local Institution - 0282
Rosario, Santa Fe Province, 2000, Argentina
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Local Institution - 0283
Santiago, RM, 7630372, Chile
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Local Institution - 0284
Pittsburgh, Pennsylvania, 15212, United States
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Local Institution - 0286
Christchurch, Canterbury, 8011, New Zealand
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Local Institution - 0288
Coronado, California, 92118, United States
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Local Institution - 0289
Rio Piedras, 00935, Puerto Rico
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Local Institution - 0290
Madrid, 28035, Spain
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Local Institution - 0292
Tucson, Arizona, 85719, United States
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Local Institution - 0295
Newark, New Jersey, 07103, United States
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Local Institution - 0296
Temuco, Araucania, 4780000, Chile
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Local Institution - 0297
Barcelona, 08035, Spain
-
Local Institution - 0298
Ghent, 9000, Belgium
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Local Institution - 0304
Dallas, Texas, 75203, United States
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Local Institution - 0307
Xi'an, Shan3xi, 710100, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody drug conjugate tested against advanced cancers
- Sparing the liver: targeted chemoembolization meets lenvatinib in liver cancer
- AI-Enhanced ultrasound aims to catch liver cancer earlier
- Can turbocharged immune cells stop liver cancer from coming back?
- Two blood markers put to the test for early liver cancer detection
- New antibody pair takes aim at advanced liver cancer in major trial