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NCT03143153CompletedPhase 3

A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin

A Randomized Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin in Subjects With Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
970 (actual)
First submitted
4 May 2017
Start date
29 Jun 2017
Primary completion date
18 Jan 2021
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT03143153
EudraCT number
2016-001514-20

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 970
  • From 29 Jun 2017 to the primary completion date, 18 Jan 2021
  • 190 sites in 27 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Active known or suspected autoimmune disease
  • Any serious or uncontrolled medical disorder or active infection
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus
    • Other protocol defined inclusion/exclusion criteria apply

Other

  • Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment

Who the study is looking for

  • Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
  • Male or Female at least 18 years of age
  • Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
  • Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
  • Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (190)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Local Institution - 0048
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Buenos AiresArgentinaUnknown status
Local Institution - 0050
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Capital FederalArgentinaUnknown status
Local Institution - 0087
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La RiojaArgentinaUnknown status
Local Institution - 0086
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RosarioArgentinaUnknown status
Local Institution - 0241
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SalzburgAustriaUnknown status
Local Institution - 0011
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DouglasAustraliaUnknown status
Local Institution - 0010
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MurdochAustraliaUnknown status
Local Institution - 0232
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TamworthAustraliaUnknown status
Local Institution - 0019
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BarretosBrazilUnknown status
Local Institution - 0021
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IjuíBrazilUnknown status
Local Institution - 0227
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IpatingaBrazilUnknown status
Local Institution - 0226
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JaúBrazilUnknown status
Local Institution - 0016
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Porto AlegreBrazilUnknown status
Local Institution - 0228
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Rio de JaneiroBrazilUnknown status
Local Institution - 0017
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SalvadorBrazilUnknown status
Local Institution - 0018
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São José do Rio PretoBrazilUnknown status
Local Institution - 0020
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São PauloBrazilUnknown status
Local Institution - 0095
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MonctonCanadaUnknown status
Local Institution - 0082
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MontrealCanadaUnknown status
Local Institution - 0222
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MontrealCanadaUnknown status
Local Institution - 0037
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Trois-RivièresCanadaUnknown status
Local Institution - 0053
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SantiagoChileUnknown status
Local Institution - 0214
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SantiagoChileUnknown status
Local Institution - 0182
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BeijingChinaUnknown status
Local Institution - 0216
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BeijingChinaUnknown status
Local Institution - 0179
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BeijingChinaUnknown status
Local Institution - 0180
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ChangchunChinaUnknown status
Local Institution - 0212
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ChangshaChinaUnknown status
Local Institution - 0249
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ChangshaChinaUnknown status
Local Institution - 0219
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FuzhouChinaUnknown status
Local Institution - 0217
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FuzhouChinaUnknown status
Local Institution - 0184
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HangzhouChinaUnknown status
Local Institution - 0185
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HarbinChinaUnknown status
Local Institution - 0197
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HefeiChinaUnknown status
Local Institution - 0207
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HefeiChinaUnknown status
Local Institution - 0247
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LinhaiChinaUnknown status
Local Institution - 0201
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NanjingChinaUnknown status
Local Institution - 0215
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ShanghaiChinaUnknown status
Local Institution - 0200
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ShanghaiChinaUnknown status
Local Institution - 0199
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ShantouChinaUnknown status
Local Institution - 0220
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ShenyangChinaUnknown status
Local Institution - 0183
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Xi'anChinaUnknown status
Local Institution - 0248
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Xi'anChinaUnknown status
Local Institution - 0193
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ZhengzhouChinaUnknown status
Local Institution - 0194
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ZhengzhouChinaUnknown status
Local Institution - 0195
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ZhengzhouChinaUnknown status
Local Institution - 0059
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BogotáColombiaUnknown status
Local Institution - 0058
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MedellínColombiaUnknown status
Local Institution - 0224
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MonteríaColombiaUnknown status
Local Institution - 0094
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PereiraColombiaUnknown status
Local Institution - 0008
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BrnoCzechiaUnknown status
Local Institution - 0083
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BrnoCzechiaUnknown status
Local Institution - 0006
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Nový JičínCzechiaUnknown status
Local Institution - 0099
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OdenseDenmarkUnknown status
Local Institution - 0063
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BarcelonaSpainUnknown status
Local Institution - 0062
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MadridSpainUnknown status
Local Institution - 0114
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CaenFranceUnknown status
Local Institution - 0116
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LilleFranceUnknown status
Local Institution - 0112
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MontpellierFranceUnknown status
Local Institution - 0113
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RennesFranceUnknown status
Local Institution - 0242
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ToulouseFranceUnknown status
Local Institution - 0115
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VillejuifFranceUnknown status
Local Institution - 0237
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LondonUnited KingdomUnknown status
Local Institution - 0066
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LondonUnited KingdomUnknown status
Local Institution - 0069
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LondonUnited KingdomUnknown status
Local Institution - 0031
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ManchesterUnited KingdomUnknown status
Local Institution - 0029
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SurreyUnited KingdomUnknown status
Local Institution - 0035
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Hong KongHong Kong SAR ChinaUnknown status
Local Institution - 0070
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KowloonHong Kong SAR ChinaUnknown status
Local Institution - 0085
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BergamoItalyUnknown status
Local Institution - 0039
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MilanItalyUnknown status
Local Institution - 0084
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PadovaItalyUnknown status
Local Institution - 0240
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PisaItalyUnknown status
Local Institution - 0170
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Akashi-shiJapanUnknown status
Local Institution - 0152
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AkitaJapanUnknown status
Local Institution - 0110
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Bunkyo-kuJapanUnknown status
Local Institution - 0106
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Bunkyo-kuJapanUnknown status
Local Institution - 0153
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ChibaJapanUnknown status
Local Institution - 0101
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ChibaJapanUnknown status
Local Institution - 0128
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Chuo-kuJapanUnknown status
Local Institution - 0136
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Chuo-kuJapanUnknown status
Local Institution - 0174
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FukuokaJapanUnknown status
Local Institution - 0142
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FukuokaJapanUnknown status
Local Institution - 0103
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FukushimaJapanUnknown status
Local Institution - 0154
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GifuJapanUnknown status
Local Institution - 0230
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Hidaka-shiJapanUnknown status
Local Institution - 0221
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HirakataJapanUnknown status
Local Institution - 0104
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Hirosaki-shiJapanUnknown status
Local Institution - 0100
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HiroshimaJapanUnknown status
Local Institution - 0127
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IseharaJapanUnknown status
Local Institution - 0229
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KagoshimaJapanUnknown status
Local Institution - 0120
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Kamigyō-kuJapanUnknown status
Local Institution - 0171
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KanazawaJapanUnknown status
Local Institution - 0173
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Kashiwa-shiJapanUnknown status
Local Institution - 0109
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Kawasaki-shiJapanUnknown status
Local Institution - 0175
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Kitaadachi-gunJapanUnknown status
Local Institution - 0172
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KobeJapanUnknown status
Local Institution - 0118
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KobeJapanUnknown status
Local Institution - 0126
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Koto-kuJapanUnknown status
Local Institution - 0141
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KumamotoJapanUnknown status
Local Institution - 0135
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Kurashiki-shiJapanUnknown status
Local Institution - 0145
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KyotoJapanUnknown status
Local Institution - 0119
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MatsuyamaJapanUnknown status
Local Institution - 0169
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MatsuyamaJapanUnknown status
Local Institution - 0156
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Minato-kuJapanUnknown status
Local Institution - 0146
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NiigataJapanUnknown status
Local Institution - 0137
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OkayamaJapanUnknown status
Local Institution - 0138
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OsakaJapanUnknown status
Local Institution - 0176
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ŌtaJapanUnknown status
Local Institution - 0245
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Ōta-kuJapanUnknown status
Local Institution - 0105
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Sagamihara-shiJapanUnknown status
Local Institution - 0111
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SapporoJapanUnknown status
Local Institution - 0098
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SayamaJapanUnknown status
Local Institution - 0144
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SendaiJapanUnknown status
Local Institution - 0148
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Shimotsuga-gunJapanUnknown status
Local Institution - 0140
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Shinagawa-kuJapanUnknown status
Local Institution - 0155
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Shinjuku-kuJapanUnknown status
Local Institution - 0196
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Shinjuku-KuJapanUnknown status
Local Institution - 0108
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ShizuokaJapanUnknown status
Local Institution - 0107
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SuitaJapanUnknown status
Local Institution - 0143
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Sunto-gunJapanUnknown status
Local Institution - 0139
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TakatsukiJapanUnknown status
Local Institution - 0231
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ToyamaJapanUnknown status
Local Institution - 0238
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Ube-shiJapanUnknown status
Local Institution - 0178
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WakayamaJapanUnknown status
Local Institution - 0117
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YokohamaJapanUnknown status
Local Institution - 0147
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YokohamaJapanUnknown status
Local Institution - 0166
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BusanSouth KoreaUnknown status
Local Institution - 0150
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DaeguSouth KoreaUnknown status
Local Institution - 0149
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DaejeonSouth KoreaUnknown status
Local Institution - 0236
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JeonjuSouth KoreaUnknown status
Local Institution - 0129
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Seongnam-siSouth KoreaUnknown status
Local Institution - 0235
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SeoulSouth KoreaUnknown status
Local Institution - 0131
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SeoulSouth KoreaUnknown status
Local Institution - 0123
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SeoulSouth KoreaUnknown status
Local Institution - 0151
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SeoulSouth KoreaUnknown status
Local Institution - 0177
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SeoulSouth KoreaUnknown status
Local Institution - 0165
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SeoulSouth KoreaUnknown status
Local Institution - 0130
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SeoulSouth KoreaUnknown status
Local Institution - 0168
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SeoulSouth KoreaUnknown status
Local Institution - 0157
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UlsanSouth KoreaUnknown status
Local Institution - 0071
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MéridaMexicoUnknown status
Local Institution - 0102
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Mexico CityMexicoUnknown status
Local Institution - 0234
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San Luis Potosí CityMexicoUnknown status
Local Institution - 0090
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Tuxtla GutiérrezMexicoUnknown status
Local Institution - 0092
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CallaoPeruUnknown status
Local Institution - 0093
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LimaPeruUnknown status
Local Institution - 0060
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LimaPeruUnknown status
Local Institution - 0024
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LublinPolandUnknown status
Local Institution - 0022
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WarsawPolandUnknown status
Local Institution - 0243
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PortoPortugalUnknown status
Local Institution - 0081
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BucharestRomaniaUnknown status
Local Institution - 0079
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Cluj-NapocaRomaniaUnknown status
Local Institution - 0076
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CraiovaRomaniaUnknown status
Local Institution - 0080
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SuceavaRomaniaUnknown status
Local Institution - 0089
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MoscowRussiaUnknown status
Local Institution - 0088
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Saint PetersburgRussiaUnknown status
Local Institution - 0034
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SingaporeSingaporeUnknown status
Local Institution - 0033
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SingaporeSingaporeUnknown status
Local Institution - 0158
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Changhua CountyTaiwanUnknown status
Local Institution - 0167
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Kaohsiung CityTaiwanUnknown status
Local Institution - 0133
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Kaohsiung CityTaiwanUnknown status
Local Institution - 0163
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Kaohsiung CountyTaiwanUnknown status
Local Institution - 0164
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KeelungTaiwanUnknown status
Local Institution - 0132
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TaichungTaiwanUnknown status
Local Institution - 0161
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TainanTaiwanUnknown status
Local Institution - 0160
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TainanTaiwanUnknown status
Local Institution - 0134
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TaipeiTaiwanUnknown status
Local Institution - 0124
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TaipeiTaiwanUnknown status
Local Institution - 0162
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TaipeiTaiwanUnknown status
Local Institution - 0159
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TaoyuanTaiwanUnknown status
Local Institution - 0074
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AtlantaUnited StatesUnknown status
Local Institution - 0210
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DallasUnited StatesUnknown status
Local Institution - 0188
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DenverUnited StatesUnknown status
Oncology Associates Of Oregon, Pc
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EugeneUnited StatesUnknown status
Local Institution - 0028
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HoustonUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
Local Institution - 0032
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MariettaUnited StatesUnknown status
Local Institution - 0186
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MiamiUnited StatesUnknown status
University of Miami - Sylvester Comprehensive Cancer Center
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MiamiUnited StatesUnknown status
Local Institution - 0191
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MobileUnited StatesUnknown status
Local Institution - 0203
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MorgantownUnited StatesUnknown status
Hackensack Meridian Jersey Shore University Medical Center
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Neptune CityUnited StatesUnknown status
Northwest Cancer Specialists, P.C.
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PortlandUnited StatesUnknown status
Local Institution - 0190
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RoanokeUnited StatesUnknown status
Local Institution - 0225
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TampaUnited StatesUnknown status
Arizona Cancer Center
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TucsonUnited StatesUnknown status
Local Institution - 0096
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AnkaraTurkey (Türkiye)Unknown status
Local Institution - 0125
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DiyarbakırTurkey (Türkiye)Unknown status
Local Institution - 0122
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EdrineTurkey (Türkiye)Unknown status

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