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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05152147
Registration number
NCT05152147
Ethics application status
Date submitted
5/11/2021
Date registered
9/12/2021
Date last updated
4/06/2024
Titles & IDs
Public title
A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
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Scientific title
A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)
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Secondary ID [1]
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0
2021-000296-36
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Secondary ID [2]
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ZWI-ZW25-301
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Universal Trial Number (UTN)
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Trial acronym
HERIZON-GEA-01
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastric Neoplasms
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0
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Gastroesophageal Adenocarcinoma
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0
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Esophageal Adenocarcinoma
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Condition category
Condition code
Cancer
0
0
0
0
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Stomach
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Zanidatamab
Treatment: Drugs - Tislelizumab
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Capecitabine
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - 5-Fluorouracil
Active Comparator: Arm A - Trastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP)
Experimental: Arm B - Zanidatamab plus physician's choice of CAPOX or FP
Experimental: Arm C - Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP
Treatment: Drugs: Zanidatamab
Administered IV
Treatment: Drugs: Tislelizumab
Administered IV
Treatment: Drugs: Trastuzumab
Administered intravenously (IV)
Treatment: Drugs: Capecitabine
Administered orally (PO bid)
Treatment: Drugs: Oxaliplatin
Administered IV
Treatment: Drugs: Cisplatin
Administered IV
Treatment: Drugs: 5-Fluorouracil
Administered IV
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival (PFS) by BICR
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Assessment method [1]
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The time from randomization to the date of documented disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) as assessed by blinded independent central review (BICR) or death from any cause
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Timepoint [1]
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Up to 2.5 years
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Primary outcome [2]
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Overall survival
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Assessment method [2]
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The time from randomization to death due to any cause
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Timepoint [2]
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Up to 3.5 years
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Secondary outcome [1]
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Confirmed objective response rate (ORR) by BICR
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Assessment method [1]
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Number of patients who achieved a best overall response of complete response (CR) or (PR) as determined per RECIST 1.1 as assessed by BICR
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Timepoint [1]
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Up to 2.5 years
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Secondary outcome [2]
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Duration of response (DOR) by BICR
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Assessment method [2]
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The time from the first objective response (CR or PR) per BICR to documented progressive disease per RECIST 1.1 as assessed by BICR or death from any cause
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Timepoint [2]
0
0
Up to 2.5 years
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Secondary outcome [3]
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PFS per Investigator assessment
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Assessment method [3]
0
0
The time from randomization to the date of documented disease progression (per RECIST 1.1) as assessed by Investigator or death from any cause
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Timepoint [3]
0
0
Up to 2.5 years
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Secondary outcome [4]
0
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Confirmed ORR per Investigator assessment
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Assessment method [4]
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0
Number of patients who achieved a best overall response of CR or PR as determined per RECIST 1.1 as assessed by Investigator
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Timepoint [4]
0
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Up to 2.5 years
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Secondary outcome [5]
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DOR per Investigator assessment
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Assessment method [5]
0
0
The time from the first objective response (CR or PR) per Investigator to documented progressive disease per RECIST 1.1 as assessed by Investigator or death from any cause
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Timepoint [5]
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Up to 2.5 years
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Secondary outcome [6]
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Assessment of Contribution of Components based on Progression-free Survival (PFS) by BICR
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Assessment method [6]
0
0
The time from randomization to the date of documented disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) as assessed by blinded independent central review (BICR) or death from any cause
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Timepoint [6]
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0
Up to 2.5 years
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Secondary outcome [7]
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Assessment of Contribution of Components based on Overall Survival
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Assessment method [7]
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0
The time from randomization to death due to any cause
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Timepoint [7]
0
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Up to 3.5 years
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Secondary outcome [8]
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Incidence of adverse events
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Assessment method [8]
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Number of subjects who experienced adverse events or serious adverse events
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Timepoint [8]
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Up to 2 years
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Secondary outcome [9]
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Incidence of clinical laboratory abnormalities
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Assessment method [9]
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Number of patients who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
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Timepoint [9]
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Up to 2 years
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Secondary outcome [10]
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Health-related quality of life (HRQoL) as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (core cancer questionnaire) C30 (QLQ-C30)
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Assessment method [10]
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Changes from baseline in the EORTC QLQ-C30 scores
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Timepoint [10]
0
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Up to 2.5 years
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Secondary outcome [11]
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HRQoL as assessed by the EORTC Quality of Life Questionnaire (oesophago-gastric module) OG25 (QLQ-OG25)
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Assessment method [11]
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Changes from baseline in the EORTC QLQ-OG25 scores
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Timepoint [11]
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Up to 2.5 years
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Secondary outcome [12]
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HRQoL as assessed by the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire
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Assessment method [12]
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0
Changes from baseline in the EORTC EQ-5D-5L questionnaire scores
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Timepoint [12]
0
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Up to 2.5 years
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Secondary outcome [13]
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Serum concentration of zanidatamab and tislelizumab
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Assessment method [13]
0
0
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Timepoint [13]
0
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Up to 2 years
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Secondary outcome [14]
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Incidence of anti-drug antibodies (ADAs)
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Assessment method [14]
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Number of patients who develop ADAs
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Timepoint [14]
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Up to 2 years
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Eligibility
Key inclusion criteria
- Histologically confirmed unresectable locally advanced, recurrent or metastatic
HER2-positive gastroesophageal adenocarcinoma (adenocarcinomas of the stomach or
esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by
IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Subjects
with esophageal adenocarcinoma must not be eligible for combined chemoradiotherapy at
the time of enrollment
- Assessable (measurable or non-measurable) disease as defined by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, assessed
within 3 days prior to randomization
- Adequate organ function
- Left ventricular ejection fraction (LVEF) = 50% as determined by either echocardiogram
or multiple gated acquisition scan (MUGA)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior treatment with a HER2-targeted agent, with the exception of subjects who
received HER2-targeted treatment for breast cancer > 5 years prior to initial
diagnosis of GEA
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or
drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Prior treatment with systemic antineoplastic therapy or intraperitoneal chemotherapy
for unresectable locally advanced, recurrent or metastatic GEA
- Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or
radiation treatment for CNS metastases within 4 weeks prior to randomization. Stable,
treated brain metastases are allowed (defined as subjects who are completely off
steroids and anticonvulsants and are neurologically stable with no evidence of
radiographic progression for at least 4 weeks prior to randomization)
- Known history of or ongoing leptomeningeal disease (LMD)
- Known additional malignancy that is not considered cured or that has required
treatment within the past 3 years
- Known active hepatitis
- Any history of human immunodeficiency virus (HIV) infection
- Known SARS-CoV-2 infection; subjects with prior infection that has resolved per local
institutions' requirements and screening guidance are eligible
- QTc Fridericia (QTcF) > 470 ms
- Clinically significant cardiac disease, such as ventricular arrhythmia requiring
therapy, uncontrolled hypertension or any history of symptomatic congestive heart
failure (CHF)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/12/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/02/2026
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Actual
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Sample size
Target
918
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Border Medical Oncology Research Unit - Albury
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Recruitment hospital [2]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [3]
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Austin Health - Heidelberg
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Recruitment hospital [4]
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Liverpool Hospital - Liverpool
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Recruitment hospital [5]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2640 - Albury
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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2170 - Liverpool
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Recruitment postcode(s) [5]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Argentina
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State/province [2]
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Ciudad Autónoma de Buenos Aires
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Argentina
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Córdoba
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Argentina
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Pergamino
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Argentina
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State/province [5]
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San Miguel De Tucumán
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Argentina
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State/province [6]
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Viedma
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Belgium
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State/province [7]
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Bonheiden
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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State/province [10]
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Leuven
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Belgium
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State/province [11]
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Liège
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Brazil
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State/province [12]
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Barretos
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Brazil
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State/province [13]
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Belo Horizonte
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Brazil
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Brasília
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Brazil
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Fortaleza
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Brazil
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Ijuí
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Brazil
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Porto Alegre
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Brazil
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Rio De Janeiro
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Brazil
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Santo André
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Brazil
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Sorocaba
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Brazil
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São Paulo
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Toronto
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Chile
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Región-Metropolitana De Santiago
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Chile
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Osorno
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Providencia
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Recoleta
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Santiago
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Chile
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Temuco
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Haikou
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Hangzhou
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China
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Harbin
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China
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Hefei
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Hohhot
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Jinan
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Kunming
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Lanzhou
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Nanchang
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Nanjing
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Shenyang
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Yangzhou
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Czechia
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Hradec Králové
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Estonia
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Tallinn
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France
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Avignon
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France
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France
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Bordeaux
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Nantes
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Rennes
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France
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Toulouse
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Georgia
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Germany
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Leipzig
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Germany
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Ulm
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Attiki
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Greece
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Thessaloniki
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Guatemala
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Guatemala City
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Guatemala
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Salcaja
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India
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Bangalore
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India
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Bhubaneswar
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India
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India
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Hyderabad
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India
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Jaipur
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India
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Nashik
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India
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New Delhi
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India
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India
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Candiolo
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Italy
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Italy
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Milano
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Italy
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Modena
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Italy
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Torino
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Italy
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Verona
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Italy
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Japan
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Gunma
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Japan
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Japan
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Hyôgo
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Japan
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Ibaraki
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Japan
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Kagawa
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Japan
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Kanagawa
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Japan
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Kumamoto
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Japan
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Kyoto-shi
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Japan
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Miyagi
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Tiba
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Japan
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Tokyo
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Japan
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Chuo Ku
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Japan
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Fukuoka-shi
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Japan
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Ina
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Japan
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Matsuyama
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Japan
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Nagoya shi
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Japan
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Niigata-shi
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Japan
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Osaka-sayama
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Japan
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Shizuoka
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Korea, Republic of
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Anyang-si
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Malaysia
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George Town
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
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Malaysia
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Putrajaya
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Mexico
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Mexico
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Oaxaca
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Eindhoven
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Leiden
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Netherlands
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Tilburg
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Poland
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Skórzewo
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Poland
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Warszawa
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Poland
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Lódz
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Portugal
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Almada
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Portugal
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Coimbra
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Portugal
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Guimarães
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Portugal
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Lisboa
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Portugal
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Loures
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Portugal
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Matosinhos
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Portugal
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Porto
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Romania
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Bucure?ti
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Romania
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Romania
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Romania
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Iasi
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Serbia
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Belgrade
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Serbia
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Niš
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Serbia
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Singapore
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South Africa
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Pretoria
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Spain
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Girona
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Spain
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L'Hospitalet de Llobregat
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Spain
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Madrid
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Málaga
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Spain
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Spain
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Zaragoza
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Taichung
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Taiwan
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Tainan
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Taipei
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Thailand
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Bangkok
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Thailand
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Hat Yai
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Country [192]
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Thailand
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Khon Kaen
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Country [193]
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Thailand
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Lak Si
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Thailand
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Phitsanulok
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Turkey
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Istanbul
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Balçova
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Turkey
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Bursa
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Turkey
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Denizli
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Turkey
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Diyarbakir
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Turkey
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Edirne
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Turkey
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Fatih
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Turkey
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Izmir
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Turkey
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Sariyer
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Turkey
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Seyhan
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Turkey
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Sur
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Turkey
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Tarabya
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Country [209]
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Turkey
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Trabzon
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Country [210]
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Turkey
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Yenimahalle
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Country [211]
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Turkey
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Çankaya
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Country [212]
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Ukraine
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Dnipropetrovsk
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Country [213]
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Ukraine
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Kharkiv
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Country [214]
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Ukraine
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State/province [214]
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Kryvyi Rih
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Country [215]
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Ukraine
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State/province [215]
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Kyiv
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Country [216]
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Ukraine
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Lutsk
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Country [217]
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Ukraine
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Odesa
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Country [218]
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United Kingdom
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Bristol
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Country [219]
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United Kingdom
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Edinburgh
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Country [220]
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United Kingdom
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Leeds
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Country [221]
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United Kingdom
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London
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Country [222]
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United Kingdom
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Northwood
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Country [223]
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United Kingdom
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Peterborough
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Country [224]
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0
United Kingdom
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State/province [224]
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0
Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Jazz Pharmaceuticals
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Address
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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
0
0
BeiGene, Ltd.
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Address [1]
0
0
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Country [1]
0
0
Query!
Ethics approval
Ethics application status
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Summary
Brief summary
This study is being done to find out if zanidatamab, when given with chemotherapy plus or
minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy.
The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive
stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or
chemoradiation, and/or have grown or spread to other parts of the body (metastatic).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05152147
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Public notes
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Contacts
Principal investigator
Name
0
0
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0
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0
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0
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Contact person for public queries
Name
0
0
Clinical Trial Disclosure & Transparency
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Address
0
0
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Country
0
0
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Phone
0
0
215-832-3750
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05152147
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