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NCT06532006RecruitingPhase 3

A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer

Source: ClinicalTrials.gov · Last updated 27 Feb 2026

Brief summary (registry, in English)

This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
550 (estimated)
First submitted
25 Jul 2024
Start date
22 Nov 2024
Primary completion date
1 Jun 2027
Lead sponsor
Shanghai Henlius Biotech
NCT number
NCT06532006
EU CT number
2024-516633-12-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 550
  • From 22 Nov 2024 to the primary completion date, 1 Jun 2027
  • 218 sites in 18 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.

Prior treatment

  • Evidence of disease progression within 6 months (before randomization) after completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
  • Previous treatment with any HER2-target therapy.

Other illness

  • Patients with other malignant tumors within 2 years before the randomization.
  • Active gastrointestinal bleeding
  • Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.

Lab values

  • Left ventricular ejection fraction (LVEF) \< 55%.

Other

  • Presence of central nervous system (CNS) metastases.

Who the study is looking for

  • Male/female who are at least 18 years of age on the day of signing the informed consent.
  • With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
  • Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
  • HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory on a primary or metastatic tumor.
  • ECOG PS within 7 days before randomization: 0-1.
  • Expected survival ≥ 6 months.
  • Had adequate organ function

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

Full criteria on ClinicalTrials.gov

Sites (218)

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

SiteCityCountrySite status
Fundacion CENIT
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Buenos AiresArgentinaRecruiting
Centro de Investigacion Pergamino SA
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Buenos AiresArgentinaRecruiting
Instituto de Oncologia de Rosario
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CordobaArgentinaRecruiting
IONC - Instituto Oncologico de Cordoba
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CórdobaArgentinaRecruiting
Centro Medico Privado CEMAIC
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CórdobaArgentinaNot yet recruiting
União Brasileira de Educação e Assistência
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Puerto AlegreArgentinaRecruiting
Sanatorio de la Mujer
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RosarioArgentinaRecruiting
Sanatorio Plaza - Fundacion Pita
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RosarioArgentinaRecruiting
Instituto San Marcos
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San JuanArgentinaRecruiting
CER - Centro de Rehabilitacion Medica San Juan
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San JuanArgentinaRecruiting
Exelsus
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San Miguel de TucumánArgentinaRecruiting
Beneficência Portuguesa de São Paulo
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San PabloArgentinaRecruiting
Centro de Investigaciones Clinicas. Clinica Viedma S. A
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ViedmaArgentinaRecruiting
GenesisCare Research
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CampbelltownAustraliaRecruiting
Concord Repatriation General Hospital
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ConcordAustraliaRecruiting
St. Vincent Hospital Melbourne
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FitzroyAustraliaRecruiting
Peninsula Health - Frankston Hospital
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FrankstonAustraliaRecruiting
Central Coast Local Health District (Gosford and Wyong Hospital)
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GosfordAustraliaRecruiting
Macquarie University
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North RydeAustraliaRecruiting
University of the Sunshine Coast Clinical Trials, Sunshine Coast Haematology and Oncology Clinic
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Sunshine CoastAustraliaRecruiting
Personal Oncologia de Precisio e Personalizada
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Belo HorizonteBrazilRecruiting
Instituto de Oncologia do Paraná - IOP Pequisa
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CuritibaBrazilRecruiting
ANIMI - Unidade de Tratamento Oncológico
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LagesBrazilRecruiting
Hospital de Clínicas de Porto Alegre - HCPA
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Porto AlegreBrazilRecruiting
Centro Gaúcho Integrado - Hospital Mae de Deus
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Porto AlegreBrazilRecruiting
Real Hospital de Beneficencia Portuguesa
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RecifeBrazilRecruiting
Clinica de Hematologia e Oncologia Viver
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Santa MariaBrazilRecruiting
Hospital Santa Marcelina HSM
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São PauloBrazilRecruiting
Brazilian Institute for Cancer Control (IBCC)
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Vila MarianaBrazilRecruiting
Centro de Oncologia de Precision
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SantiagoChileRecruiting
Icegclinic
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SantiagoChileRecruiting
Fundacion Arturo Lopez Perez
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SantiagoChileRecruiting
Instituto del Cancer RedSalud Vitacura
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SantiagoChileRecruiting
Affiliated Hospital of Youjiang Medical University for Nationalities
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Baise CityChinaRecruiting
Peking Union Medical College Hospital
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BeijingChinaRecruiting
Beijing Cancer Hospital
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BeijingChinaRecruiting
Cancer Hospital, Chinese Academy of Medical Sciences
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BeijingChinaRecruiting
The First Affiliated Hospital of Bengbu Medical University
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BengbuChinaRecruiting
The First Hospital of Jilin University
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ChangchunChinaRecruiting
Hunan Cancer Hospital
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ChangshaChinaRecruiting
Heping Hospital Affiliated to Changzhi Medical College
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ChangzhiChinaRecruiting
The First People's Hospital Of Changzhou
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ChangzhouChinaRecruiting
Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital
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ChengduChinaRecruiting
West China Hospital of Sichuan University
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ChengduChinaRecruiting
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaRecruiting
Dezhou Second People's hospital
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DezhouChinaRecruiting
Fujian Cancer Hospital
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FuzhouChinaRecruiting
Zhongshan City People's Hospital
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GuangdongChinaRecruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
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GuangzhouChinaRecruiting
The First Affiliated Hospital, Zhejiang University School of Medic
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HangzhouChinaRecruiting
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
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HangzhouChinaRecruiting
Harbin Medical University Cancer Hospital
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HarbinChinaRecruiting
The Second Hospital of Anhui Medical University
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HefeiChinaRecruiting
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaRecruiting
Cancer Hospital of Shandong First Medical University
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JinanChinaRecruiting
Gansu Provincial Hospital
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LanzhouChinaRecruiting
Gansu Wuwei Tumour Hospital
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LanzhouChinaRecruiting
Gansu Provincial Cancer Hospital
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LanzhouChinaRecruiting
The First Hospital of Lanzhou University
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LanzhouChinaRecruiting
Liuzhou Workers Hospital
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LiuzhouChinaRecruiting
The First Affiliated Hospital of Henan University of Science
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LuoyangChinaRecruiting
Mianyang Central Hospital
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MianyangChinaRecruiting
The First Affiliated Hospital of NanChang University
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NanchangChinaRecruiting
Jiangsu Province Hospital
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NanjingChinaRecruiting
Nanjing Drum Tower hospital
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NanjingChinaRecruiting
The Affiliated Hospital of Qingdao University
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QingdaoChinaRecruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaRecruiting
Fudan University Shanghai Cancer Center
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ShanghaiChinaRecruiting
The Central Hospital of Shaoyang
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ShaoyangChinaRecruiting
Liaoning Medical University Cancer Institute & Hospital
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ShenyangChinaRecruiting
The Fourth Hospital of Hebei Medical University
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Shijia ZhuangChinaRecruiting
Shanxi Cancer hospital
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TaiyuanChinaRecruiting
Tianjin Medical University Cancer Institute & Hospital
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TianjinChinaRecruiting
Cancer Hospital Affiliated to Xinjiang Medical University
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ÜrümqiChinaRecruiting
The First Affiliated hospital of Xiamen University
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XiamenChinaRecruiting
Qinghai university affiliated hospital
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XiningChinaRecruiting
Xuzhou Central Hospital
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XuzhouChinaRecruiting
Yichang Central People's Hospital
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YichangChinaRecruiting
General Hospital of Ningxia Medical University
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YinchuanChinaRecruiting
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaRecruiting
Henan Cancer Hospital
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ZhengzhouChinaRecruiting
Klinikum St. Marien Amberg
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AmbergGermanyRecruiting
Evangelisches Klinikum Bethel gGmbH
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BielefeldGermanyRecruiting
Technische Universitaet Dresden
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DresdenGermanyRecruiting
KEM I Evang. Kliniken Essen-Mitte gGmbH
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EssenGermanyRecruiting
Haematologisch-Onkologische Praxis Eppendorf (HOPE)
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HamburgGermanyRecruiting
Medizinische Hochschule Hannover
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HanoverGermanyRecruiting
SLK-Kliniken Heilbronn GmbH
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HeilbronnGermanyRecruiting
Universitaetsklinikum Jena KöR
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JenaGermanyRecruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyRecruiting
Kreiskliniken Reutlingen gGmbH
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ReutlingenGermanyRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
Hospital Universitario Central De Asturias
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OviedoSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
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ValenciaSpainRecruiting
Hospital Alvaro Cunqueiro
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VigoSpainRecruiting
JSV VIAN- Caraps Medline
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TbilisiGeorgiaRecruiting
Evex Hospitals - Caucasus Medical Center
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TbilisiGeorgiaRecruiting
LTD "New Hospitals"
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TbilisiGeorgiaRecruiting
Tbilisi State Medical University and Ingorovka High Medical Technology University Clinic Ltd
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TbilisiGeorgiaRecruiting
Llc Todua Clinic
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TbilisiGeorgiaRecruiting
Athens Medical Center S.A.
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AthensGreeceRecruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceRecruiting
Saint Savvas Oncology Hospital
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AthensGreeceRecruiting
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceRecruiting
General Oncological Hospital Of Kifissia Agioi Anargyroi
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KifissiaGreeceRecruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyRecruiting
Azienda Ospedaliera Sant'Anna E San Sebastiano Di Caserta
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CasertaItalyRecruiting
Azienda Socio-Sanitaria Territoriale di Cremona
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CremonaItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyRecruiting
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyRecruiting
Hyogo Cancer Center
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Akashi-shiJapanRecruiting
National Cancer Center Hospital
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Chuo KuJapanRecruiting
National Hospital Organization Osaka National Hospital
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Chuo-ku Osaka-shiJapanRecruiting
Gifu University Hospital
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GifuJapanRecruiting
Hamamatsu University Hospital
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HamamatsuJapanRecruiting
Hiroshima City Hiroshima Citizens Hospital
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HiroshimaJapanRecruiting
Izumi City General Hospital
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Izumi-shiJapanRecruiting
Ishikawa Prefectural Central Hospital
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KanazawaJapanRecruiting
Ibaraki Prefectural Central Hospital, Ibaraki Cancer Center
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Kasama-shiJapanRecruiting
The Cancer Institute Hospital of JFCR
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KōtokuJapanRecruiting
Gunma University Hospital
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MaebashiJapanRecruiting
Osaka Keisatsu Hospital
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OsakaJapanRecruiting
Osaka International Cancer Institute
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OsakaJapanRecruiting
Osaki Citizen Hospital
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Osaki-ShiJapanRecruiting
Saitama Cancer Center
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SaitamaJapanRecruiting
Keiyukai Sapporo Hospital
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SapporoJapanRecruiting
Hokkaido University Hospital
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SapporoJapanRecruiting
Teine Keijinkai Hospital
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SapporoJapanRecruiting
Shizuoka General Hospital
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ShizuokaJapanRecruiting
Suita Municipal Hospital
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SuitaJapanRecruiting
Kagawa University Hospital
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TakamatsuJapanRecruiting
Osaka Medical and Pharmaceutical University Hospital
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Takatsuki-shiJapanRecruiting
Toyonaka Municipal Hospital
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Toyonaka-shiJapanRecruiting
Tochigi Cancer Center
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UtsunomiyaJapanRecruiting
Wakayama Medical University Hospital
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WakayamaJapanRecruiting
Yamagata Prefectural Central Hospital
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YamagataJapanRecruiting
Chungbuk National University Hospital
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Cheongju-siSouth KoreaRecruiting
Jeonbuk National University Hospital
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Cheongju-siSouth KoreaRecruiting
Gyeongsang National University Hospital
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JinjuSouth KoreaRecruiting
Kangbuk Samsung Hospital
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SeoulSouth KoreaRecruiting
Korea University Guro Hospital
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Korea University Anam Hospital
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SeoulSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Instiruto Nacional de Enfermedades Neoplasicas
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LimaPeruRecruiting
Centro Especializado en Oncologia de Precision
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LimaPeruRecruiting
Institutto Peruano de Oncologia y Radioterapia
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San IsidroPeruRecruiting
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
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BrzozówPolandRecruiting
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
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KoszalinPolandRecruiting
IP Clinic Sp. z o.o.
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LodzPolandRecruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
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LublinPolandRecruiting
Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
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OtwockPolandRecruiting
Aidport sp z o.o.
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SkorzewoPolandRecruiting
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
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SlupskPolandRecruiting
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Lusiadas S.A.
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LisbonPortugalRecruiting
Hospital Cuf Tejo S.A.
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LisbonPortugalRecruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalRecruiting
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
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Vila RealPortugalRecruiting
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
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Cluj-NapocaRomaniaRecruiting
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaRecruiting
Radiotherapy Center Cluj S.R.L.
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FlorestiRomaniaRecruiting
Pelican Impex S.R.L.
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OradeaRomaniaRecruiting
Sigmedical Services S.R.L.
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SuceavaRomaniaRecruiting
Texas Oncology - West (SCRI)
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AbileneUnited StatesRecruiting
Los Angeles Cancer Network
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AnaheimUnited StatesRecruiting
Texas Oncology Central South (SCRI)
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AustinUnited StatesRecruiting
University of Chicago
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ChicagoUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
Advanced Research LLC
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Deerfield BeachUnited StatesRecruiting
Texas Oncology Northeast (SCRI)
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DentonUnited StatesRecruiting
Mission Cancer + Blood (Exigent Network)
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Des MoinesUnited StatesRecruiting
Florida Cancer Specialist South
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Fort MyersUnited StatesRecruiting
Banner MD Anderson Cancer Center
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GreeleyUnited StatesRecruiting
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
Holden Comprehensive Cancer Center - University of Iowa
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Iowa CityUnited StatesRecruiting
Comprehensive Cancer Centers Nevada
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Las VegasUnited StatesRecruiting
OPN - Oncology Physician Network (Los Alamitos)
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Los AlamitosUnited StatesRecruiting
West Virginia University Cancer Institute
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MorgantownUnited StatesRecruiting
HCA Midwest Health
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NashvilleUnited StatesRecruiting
Vanderbilt University Medical Center
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NashvilleUnited StatesRecruiting
American Oncology Network Vista Oncology Division
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OlympiaUnited StatesRecruiting
Nebraska Cancer Specialists
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OmahaUnited StatesRecruiting
UPMC Hillman Cancer Center
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PittsburghUnited StatesRecruiting
BRCR Medical Center
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PlantationUnited StatesRecruiting
Napa Research
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Pompano BeachUnited StatesRecruiting
Guthrie Medical Group, PC and Robert Packer Hospital (Guthrie Cancer Center - Sayre)
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SayreUnited StatesRecruiting
Washington University School of Medicine - St. Louis
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St LouisUnited StatesRecruiting
Florida Cancer Specialist-North
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St. PetersburgUnited StatesRecruiting
Northwest Medical Specialties
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TacomaUnited StatesRecruiting
Texas Oncology - Gulf Coast (SCRI)
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WebsterUnited StatesRecruiting
Florida Cancer Specialist - East
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West Palm BeachUnited StatesRecruiting
Baskent University Adana Dr Turgut Noyan Research and Application Center
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AdanaTurkey (Türkiye)Recruiting
Medical Park Seyhan Hospital
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AdanaTurkey (Türkiye)Recruiting
Ankara City Hospital
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AnkaraTurkey (Türkiye)Recruiting
Ankara University Medicine Faculty Cebeci Hospital
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AnkaraTurkey (Türkiye)Recruiting
Dicle University Medical Faculty Oncology Hospital
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DiyarbakırTurkey (Türkiye)Recruiting
Balkan Oncology Hospital, Trakya University
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EdirneTurkey (Türkiye)Recruiting
Ataturk University Faculty Of Medicine Research Hospital Medical Oncology
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ErzurumTurkey (Türkiye)Recruiting
Kayseri Memorial Hospital
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KayseriTurkey (Türkiye)Recruiting
Kocaeli University Hospital
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KocaeliTurkey (Türkiye)Recruiting
Sakarya Training and Research Hospital
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SakaryaTurkey (Türkiye)Recruiting
Tekirdag namik kemal university hospital medical oncology klinik
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TekirdağTurkey (Türkiye)Recruiting

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