JOURNAL ONKOLOGIE – STUDIE

HERIZON-GEA-01

A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05152147

Studienbeginn:
Dezember 2021

Letztes Update:
27.03.2024

Wirkstoff:
Zanidatamab, Tislelizumab, Trastuzumab, Capecitabine, Oxaliplatin, Cisplatin, 5-Fluorouracil

Indikation (Clinical Trials):
Adenocarcinoma, Stomach Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Jazz Pharmaceuticals

Collaborator:
BeiGene, Ltd.

Kontakt

Clinical Trial Disclosure & Transparency
Kontakt:
Phone: 215-832-3750
E-Mail: ClinicalTrialDisclosure@JazzPharma.com» Kontaktdaten anzeigen

Studienlocations
(3 von 314)

Research Site
Frankfurt am Main
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps

Leberkrebszentrum Medizinische Hochschule Hannover
Carl-Neuberg-Straße 1
30625 Hannover
DeutschlandRekrutierend» Google-Maps

Universitaetsklinikum Leipzig
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps

Research Site
Trier
(Rheinland-Pfalz)
GermanyNoch nicht rekrutierend» Google-Maps

Universitaetsklinikum Ulm
89081 Ulm
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Hospital de Gastroenterología Dr Bonorino Udaondo
1264 Buenos Aires
ArgentinaRekrutierend» Google-Maps

Hospital Italiano de Buenos Aires
C1181ACH Buenos Aires
ArgentinaRekrutierend» Google-Maps

Instituto de Investigaciones Metabólicas - IDIM
C1012 Ciudad Autónoma de Buenos Aires
ArgentinaRekrutierend» Google-Maps

Fundación Centro de Medicina Nuclear y Molecular ER
X5000HXL Córdoba
ArgentinaRekrutierend» Google-Maps

Centro Médico Privado CEMAIC
X5008HHW Córdoba
ArgentinaRekrutierend» Google-Maps

Centro de Investigación Pergamino S.A.
2700 Pergamino
ArgentinaRekrutierend» Google-Maps

Centro de Investigaciones Médicas Tucumán
T4000AXL San Miguel De Tucumán
ArgentinaRekrutierend» Google-Maps

Centro de Investigación Clínica - Clínica Viedma
R8500ACE Viedma
ArgentinaRekrutierend» Google-Maps

Border Medical Oncology Research Unit
2640 Albury
AustraliaZurückgezogen» Google-Maps

Flinders Medical Centre
5042 Bedford Park
AustraliaRekrutierend» Google-Maps

Austin Health
3084 Heidelberg
AustraliaRekrutierend» Google-Maps

Liverpool Hospital
2170 Liverpool
AustraliaRekrutierend» Google-Maps

Fiona Stanley Hospital
6150 Murdoch
AustraliaRekrutierend» Google-Maps

Imelda VZW
2820 Bonheiden
BelgiumRekrutierend» Google-Maps

Cliniques Universitaires Saint-Luc
1200 Brussels
BelgiumRekrutierend» Google-Maps

UZ Gent
9000 Gent
BelgiumRekrutierend» Google-Maps

UZ Leuven
3000 Leuven
BelgiumRekrutierend» Google-Maps

CHU de Liège
4000 Liège
BelgiumRekrutierend» Google-Maps

Fundação Pio XII Hospital de Câncer de Barretos
14784-400 Barretos
BrazilRekrutierend» Google-Maps

Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
14784-400 Barretos
BrazilRekrutierend» Google-Maps

Cenantron - Centro Avancado de Tratamento Oncologico Ltda
30130-090 Belo Horizonte
BrazilRekrutierend» Google-Maps

Hospital Amaral Carvalho
70840-901 Brasília
BrazilRekrutierend» Google-Maps

Instituto Do Câncer Do Ceará ICC
60430-230 Fortaleza
BrazilRekrutierend» Google-Maps

Associação Hospital de Caridade Ijuí
98700-000 Ijuí
BrazilRekrutierend» Google-Maps

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
90050-170 Porto Alegre
BrazilRekrutierend» Google-Maps

Irmandade Da Santa Casa de Misericordia de Porto Alegre
90050-170 Porto Alegre
BrazilRekrutierend» Google-Maps

Hospital Sao Lucas da PUCRS
90610-000 Porto Alegre
BrazilRekrutierend» Google-Maps

Hospital Nossa Senhora Da Conceição
91350-200 Porto Alegre
BrazilRekrutierend» Google-Maps

INCA - Instituto Nacional de Câncer José Alencar G
20231-050 Rio De Janeiro
BrazilRekrutierend» Google-Maps

Instituto Brasileiro de Controle Do Câncer IBCC
09060-650 Santo André
BrazilRekrutierend» Google-Maps

Instituto de Oncologia de Sorocaba
18030-075 Sorocaba
BrazilRekrutierend» Google-Maps

Instituto do Cancer do Estado de São Paulo ICESP
01246-000 São Paulo
BrazilRekrutierend» Google-Maps

Princess Margaret Cancer Centre
M5G 2C1 Toronto
CanadaRekrutierend» Google-Maps

Corporacion de Beneficencia Osorno
5290000 Osorno
ChileAbgeschlossen» Google-Maps

Centro de Estudios Clínicos SAGA SpA
7500000 Providencia
ChileRekrutierend» Google-Maps

Research Site
Providencia
ChileNoch nicht rekrutierend» Google-Maps

Meditek Ltda
8420000 Recoleta
ChileRekrutierend» Google-Maps

Sociedad Oncovida S.A
7500000 Santiago
ChileRekrutierend» Google-Maps

Icegclinic
8150513 Santiago
ChileRekrutierend» Google-Maps

BIOCINETIC SpA
8330336 Santiago
ChileRekrutierend» Google-Maps

Sociedad de Investigaciones Medicas Limitada
4810469 Temuco
ChileRekrutierend» Google-Maps

Beijing Chao-Yang Hospital, Capital Medical University
100020 Beijing
ChinaAktiv, nicht rekrutierend» Google-Maps

Cancer Hospital Chinese Academy of Medical Sciences
100021 Beijing
ChinaAktiv, nicht rekrutierend» Google-Maps

Beijing Tiantan Hospital, Capital Medical University
100050 Beijing
ChinaAbgebrochen» Google-Maps

Beijing Cancer Hospital
100142 Beijing
ChinaAktiv, nicht rekrutierend» Google-Maps

Peking University Third Hospital
100191 Beijing
ChinaAktiv, nicht rekrutierend» Google-Maps

Beijing Hospital
100730 Beijing
ChinaAktiv, nicht rekrutierend» Google-Maps

Peking Union Medical College Hospital
100730 Beijing
ChinaZurückgezogen» Google-Maps

Beijing Luhe Hospital, Capital Medical University
101199 Beijing
ChinaAktiv, nicht rekrutierend» Google-Maps

The First Affiliated Hospital of Bengbu Medical College
233004 Bengbu
ChinaAktiv, nicht rekrutierend» Google-Maps

Hunan Cancer Hospital
410031 Changsha
ChinaAktiv, nicht rekrutierend» Google-Maps

Changzhi People Hospital
046099 Changzhi
ChinaAktiv, nicht rekrutierend» Google-Maps

The First People's Hospital of Changzhou
213004 Changzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

Sichuan Cancer Hospital & Institute
610042 Chengdu
ChinaAktiv, nicht rekrutierend» Google-Maps

Foshan First People's Hospital
528000 Foshan
ChinaZurückgezogen» Google-Maps

The First Affiliated Hospital of Fujian Medical University
350005 Fuzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

Fujian Cancer Hospital
350014 Fuzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

Guangdong Provincial People's Hospital
510055 Guangzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

The Sixth Affiliated Hospital of Sun Yat-sen University
510655 Guangzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

Hainan General Hospital
570311 Haikou
ChinaAktiv, nicht rekrutierend» Google-Maps

The First Affiliated Hospital, College of Medicine, Zhejiang University
310003 Hangzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
310016 Hangzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

Second Affiliated Hospital of Zhejiang University School of Medicine
310017 Hangzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

Zhejiang Cancer Hospital
310022 Hangzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

Harbin Medical University Cancer Hospital
150081 Harbin
ChinaAktiv, nicht rekrutierend» Google-Maps

Anhui Provincial Cancer Hospital
230031 Hefei
ChinaAktiv, nicht rekrutierend» Google-Maps

The Second Affiliated Hospital of Anhui Medical University
230601 Hefei
ChinaAktiv, nicht rekrutierend» Google-Maps

Affiliated Hospital of Inner Mongolia Medical University
01000 Hohhot
ChinaAktiv, nicht rekrutierend» Google-Maps

Shandong Cancer Hospital
250000 Jinan
ChinaAktiv, nicht rekrutierend» Google-Maps

Jinan Cancer Hospital
250013 Jinan
ChinaAktiv, nicht rekrutierend» Google-Maps

Yunnan Cancer Hospital
650118 Kunming
ChinaAktiv, nicht rekrutierend» Google-Maps

The First Hospital of Lanzhou University
730013 Lanzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

Gansu Provincial Cancer Hospital
730050 Lanzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

The First Affiliated Hospital of Nanchang University
330052 Nanchang
ChinaAktiv, nicht rekrutierend» Google-Maps

Nanjing Drum Tower Hospital ,The Affiliated Hospital of Nanjing University Medical School
210008 Nanjing
ChinaAktiv, nicht rekrutierend» Google-Maps

The Affiliated Hospital of Qingdao University
266003 Qingdao
ChinaAktiv, nicht rekrutierend» Google-Maps

Ruijin hospital Shanghai Jiao Tong University School of Medicine
200025 Shanghai
ChinaAktiv, nicht rekrutierend» Google-Maps

Fudan University Affiliated Zhongshan Hospital
200032 Shanghai
ChinaAktiv, nicht rekrutierend» Google-Maps

Fudan University Shanghai Cancer Center
200032 Shanghai
ChinaAktiv, nicht rekrutierend» Google-Maps

Shanghai 10th People's Hospital
200072 Shanghai
ChinaAktiv, nicht rekrutierend» Google-Maps

Shanghai General Hospital
200080 Shanghai
ChinaAktiv, nicht rekrutierend» Google-Maps

Shanghai East Hospital
200120 Shanghai
ChinaZurückgezogen» Google-Maps

Research Site 1
Shanghai
ChinaAktiv, nicht rekrutierend» Google-Maps

Research Site 2
Shanghai
ChinaAktiv, nicht rekrutierend» Google-Maps

Shangrao People's Hospital
334000 Shangrao
ChinaAktiv, nicht rekrutierend» Google-Maps

The First Hospital of China Medical University
110001 Shenyang
ChinaAktiv, nicht rekrutierend» Google-Maps

Liaoning Cancer Hospital & Institute
110801 Shenyang
ChinaAktiv, nicht rekrutierend» Google-Maps

Shenzehen People's Hospital
518001 Shenzhen
ChinaZurückgezogen» Google-Maps

Peking University Shenzhen Hospital
518035 Shenzhen
ChinaAktiv, nicht rekrutierend» Google-Maps

Research Site
Shenzhen
ChinaAktiv, nicht rekrutierend» Google-Maps

The Fourth Hospital of Hebei Medical University
50011 Shijiazhuang
ChinaAktiv, nicht rekrutierend» Google-Maps

Tianjin Medical University General Hospital
300041 Tianjin
ChinaAktiv, nicht rekrutierend» Google-Maps

Tianjin Medical University Cancer Institute & Hospital
300060 Tianjin
ChinaAktiv, nicht rekrutierend» Google-Maps

The Tonghua Central Hospital
143099 Tonghua
ChinaAktiv, nicht rekrutierend» Google-Maps

Weihai Municipal Hospital
264200 Weihai
ChinaAktiv, nicht rekrutierend» Google-Maps

The First Affiliated Hospital of Wenzhou Medical University
325000 Wenzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

Union Hospital Tongji Medical College HuaZhong University of Science and Technology
430023 Wuhan
ChinaAktiv, nicht rekrutierend» Google-Maps

Hubei Cancer Hospital
430079 Wuhan
ChinaAktiv, nicht rekrutierend» Google-Maps

Affiliated Hospital of Jiangnan University
214062 Wuxi
ChinaAktiv, nicht rekrutierend» Google-Maps

First Affiliated Hospital of Xi 'an Jiaotong University
710061 Xi'an
ChinaAktiv, nicht rekrutierend» Google-Maps

The First Affiliated Hospital of Xiamen University
361003 Xiamen
ChinaAktiv, nicht rekrutierend» Google-Maps

Northern Jiangsu People's Hospital
225001 Yangzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

Henan Cancer Hospital
450003 Zhengzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

The First Affiliated Hospital of Zhengzhou University
450052 Zhengzhou
ChinaAktiv, nicht rekrutierend» Google-Maps

Cancer Hospital affiliated to Xinjiang Medical University
830026 Ürümqi
ChinaAktiv, nicht rekrutierend» Google-Maps

Fakultni nemocnice Olomouc
500 05 Hradec Králové
CzechiaZurückgezogen» Google-Maps

East Tallinn Central Hospital
11312 Tallinn
EstoniaRekrutierend» Google-Maps

North Estonia Medical Centre Foundation
13419 Tallinn
EstoniaRekrutierend» Google-Maps

Institut Sainte Catherine
84000 Avignon
FranceRekrutierend» Google-Maps

Hopital Jean Minjoz
25030 Besançon
FranceRekrutierend» Google-Maps

EDOG - Institut Bergonie - PPDS
33000 Bordeaux
FranceRekrutierend» Google-Maps

Universite de Bourgogne - Faculte de Medecine - IN
21079 Dijon
FranceRekrutierend» Google-Maps

Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon
38043 Grenoble
FranceRekrutierend» Google-Maps

Centre Léon Berard
69008 Lyon
FranceRekrutierend» Google-Maps

EDOG Institut de Cancerologie de l'Ouest - PPDS
44805 Nantes
FranceRekrutierend» Google-Maps

CHRU de Poitiers La Miletrie
86021 Poitiers
FranceRekrutierend» Google-Maps

EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
35000 Rennes
FranceRekrutierend» Google-Maps

CHRU de Brest - Hopital Morvan
42270 Saint-Priest-en-Jarez
FranceRekrutierend» Google-Maps

Hôpital de Rangueil
69437 Toulouse
FranceRekrutierend» Google-Maps

Hôpital Saint Antoine
94800 Villejuif
FranceRekrutierend» Google-Maps

LTD TIM, Tbilisi Institute of Medicine
0112 Tbilisi
GeorgiaRekrutierend» Google-Maps

Research Institute of Clinical Medicine
0112 Tbilisi
GeorgiaRekrutierend» Google-Maps

Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies
0144 Tbilisi
GeorgiaRekrutierend» Google-Maps

High Technology Hospital MedCenter Ltd
6000 Tbilisi
GeorgiaRekrutierend» Google-Maps

Metaxa Memorial Cancer Hospital Piraeus Dept. οf Medical Oncology
185 37 Peiraias
GreeceZurückgezogen» Google-Maps

Aretaieio Hospital of Athens
115 28 Athens
GreeceRekrutierend» Google-Maps

Attikon University General Hospital
124 64 Athens
GreeceRekrutierend» Google-Maps

Research Site
Piraeus
GreeceNoch nicht rekrutierend» Google-Maps

Bioclinic Thessaloniki Oncology Department
54622 Thessaloniki
GreeceRekrutierend» Google-Maps

Agios Loucas Clinic SA
552 36 Thessaloniki
GreeceRekrutierend» Google-Maps

Interbalkan Medical Center of Thessaloniki Oncology Department
57001 Thessaloniki
GreeceRekrutierend» Google-Maps

Celan S.A.
01010 Guatemala City
GuatemalaRekrutierend» Google-Maps

Integra Cancer Institute
01010 Guatemala City
GuatemalaRekrutierend» Google-Maps

Grupo Medico Angeles
01015 Guatemala City
GuatemalaRekrutierend» Google-Maps

Centro Medico Integral de Cancerologia CEMIC
09002 Salcaja
GuatemalaRekrutierend» Google-Maps

The Bangalore Hospital
560068 Bangalore
IndiaRekrutierend» Google-Maps

All India Institute of Medical Sciences, Bhubaneswar
751019 Bhubaneswar
IndiaRekrutierend» Google-Maps

Artemis Hospital
122003 Gurgaon
IndiaRekrutierend» Google-Maps

MNJ Institute of Oncology and Regional Cancer Centre
500004 Hyderabad
IndiaRekrutierend» Google-Maps

Research Site
Jaipur
IndiaNoch nicht rekrutierend» Google-Maps

Curie Manavata Cancer Centre
422002 Nashik
IndiaRekrutierend» Google-Maps

Indraprastha Apollo Hospitals
110076 New Delhi
IndiaRekrutierend» Google-Maps

Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
800014 Patna
IndiaRekrutierend» Google-Maps

Deenanath Mangeshkar Hospital and Research Centre
411006 Pune
IndiaRekrutierend» Google-Maps

HCG City Cancer Center
520002 Vijayawada
IndiaRekrutierend» Google-Maps

St James's Hospital
8 Dublin
IrelandRekrutierend» Google-Maps

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
40138 Bologna
ItalyRekrutierend» Google-Maps

Fondazione del Piemonte per l'Oncologia (IRCCS)
10060 Candiolo
ItalyRekrutierend» Google-Maps

Ospedale Policlinico San Martino
16132 Genova
ItalyRekrutierend» Google-Maps

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
47014 Meldola
ItalyRekrutierend» Google-Maps

Ospedale San Raffaele S.r.l. - PPDS
20132 Milano
ItalyRekrutierend» Google-Maps

Istituto Nazionale Dei Tumori
20133 Milano
ItalyRekrutierend» Google-Maps

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
20162 Milano
ItalyRekrutierend» Google-Maps

Azienda Ospedaliero Universitaria Di Modena Policlinico
41124 Modena
ItalyRekrutierend» Google-Maps

Arcispedale Santa Maria Nuova
43100 Reggio Emilia
ItalyRekrutierend» Google-Maps

Fondazione Policlinico Universitario A Gemelli
00168 Rome
ItalyRekrutierend» Google-Maps

Azienda Ospedaliera Città della Salute e della Scienza di Torino
10126 Torino
ItalyRekrutierend» Google-Maps

Centro Ricerche Cliniche Di Verona
37134 Verona
ItalyRekrutierend» Google-Maps

Azienda ULSS 8 "Berica" - Ospedale San Bortolo
36100 Vicenza
ItalyRekrutierend» Google-Maps

Gifu University Hospital
501-1112 Gifu-Shi
JapanRekrutierend» Google-Maps

Gunma Prefectural Cancer Center
373-8550 Ota-shi
JapanRekrutierend» Google-Maps

Fukui Prefectural Hospital
910-8526 Fukui-shi
JapanRekrutierend» Google-Maps

Hyogo Cancer Center
673-8558 Akashi-shi
JapanRekrutierend» Google-Maps

Kobe City Medical Center General Hospital
650-0047 Kobe-Shi Chuo-Ku
JapanNoch nicht rekrutierend» Google-Maps

Ibaraki Prefectural Central Hospital
309-1793 Kasama-Shi
JapanNoch nicht rekrutierend» Google-Maps

Kagawa University Hospital
761-0701 Kita-Gun Miki-Cho
JapanRekrutierend» Google-Maps

Kanagawa Cancer Center
241-0815 Yokohama-Shi Asahi-Ku
JapanNoch nicht rekrutierend» Google-Maps

Kitasato University Hospital
232-0006 Yokohama-Shi Minami-Ku
JapanRekrutierend» Google-Maps

Kumamoto University Hospital - Honjo-Kuhonji Campus A
860-8556 Chuo-Ku
JapanRekrutierend» Google-Maps

Kyoto University Hospital
606-8507 Sakyo-ku
JapanRekrutierend» Google-Maps

Osaki Citizen Hospital
989-6136 Osaki-Shi
JapanRekrutierend» Google-Maps

Kurashiki Central Hospital
710-0052 Kurashiki-Shi
JapanRekrutierend» Google-Maps

Kansai Medical University Hospital
573-1191 Hirakata
JapanRekrutierend» Google-Maps

Osaka University Hospital
565-0871 Suita-Shi
JapanRekrutierend» Google-Maps

Osaka Medical and Pharmaceutical University Hospital
569-8686 Takatsuki-Shi
JapanRekrutierend» Google-Maps

Chiba Cancer Center
260-0801 Chiba-Shi
JapanNoch nicht rekrutierend» Google-Maps

National Cancer Center Hospital East
277-8577 Kashiwa-shi
JapanRekrutierend» Google-Maps

Keio University Hospital
160-8582 Shinjuku-Ku
JapanNoch nicht rekrutierend» Google-Maps

National Cancer Center Hospital
104-0045 Chuo Ku
JapanRekrutierend» Google-Maps

National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka-shi
JapanNoch nicht rekrutierend» Google-Maps

Saitama Cancer Center
362-0806 Ina
JapanRekrutierend» Google-Maps

Shikoku Cancer Center
791-0245 Matsuyama
JapanRekrutierend» Google-Maps

Aichi Cancer Center
464-8681 Nagoya shi
JapanRekrutierend» Google-Maps

Kindai University Hospital
589-0014 Osaka-sayama
JapanRekrutierend» Google-Maps

Osaka International Cancer Institute
540-0008 Osaka
JapanRekrutierend» Google-Maps

Shizuoka Cancer Center
411-0934 Shizuoka
JapanRekrutierend» Google-Maps

The Cancer Institute Hospital of Japanese Foundation For Cancer Research
135-8550 Tokyo
JapanRekrutierend» Google-Maps

Hallym University Sacred Heart Hospital
14068 Anyang-si
Korea, Republic ofRekrutierend» Google-Maps

Dong-A University Hospital
49201 Busan
Korea, Republic ofRekrutierend» Google-Maps

Kyungpook National University Chilgok Hospital
41404 Daegu
Korea, Republic ofRekrutierend» Google-Maps

National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps

Gachon University Gil Medical Center
21565 Incheon
Korea, Republic ofRekrutierend» Google-Maps

CHA Bundang Medical Center, CHA University
13496 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps

Seoul National University Bundang Hospital
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps

Korea University Anam Hospital
02841 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps

The Catholic University of Korea, Seoul St. Mary's Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Kangbuk Samsung Hospital
03181 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Severance Hospital Yonsei University Health System - PPDS
03686 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Gangnam Severance Hospital, Yonsei University Health System
06229 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Korea University Guro Hospital
08308 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Hospital Pulau Pinang
10990 George Town
MalaysiaRekrutierend» Google-Maps

Pantai Hospital Kuala Lumpur
59100 Kuala Lumpur
MalaysiaRekrutierend» Google-Maps

University Malaya Medical Centre
59100 Kuala Lumpur
MalaysiaRekrutierend» Google-Maps

Sarawak General Hospital
93586 Kuching
MalaysiaRekrutierend» Google-Maps

National Cancer Institute ( Institut Kanser Negara)
62675 Putrajaya
MalaysiaRekrutierend» Google-Maps

Cryptex Investigación Clínica, S.A. de C.V.
06100 Mexico City
MexicoRekrutierend» Google-Maps

Clinstile, S.A. de C.V.
14080 Mexico City
MexicoRekrutierend» Google-Maps

Research Site 2
Mexico City
MexicoNoch nicht rekrutierend» Google-Maps

Hospital Universitario Dr. Jose Eleuterio González
64460 Monterrey
MexicoRekrutierend» Google-Maps

Centro de Investigacion Clinica de Oaxaca
68020 Oaxaca
MexicoRekrutierend» Google-Maps

Catharina Hospital
5623 EJ Eindhoven
NetherlandsRekrutierend» Google-Maps

Universitair Medisch Centrum Groningen
9713 GZ Groningen
NetherlandsRekrutierend» Google-Maps

Leids Universitair Medisch Centrum
2333 ZA Leiden
NetherlandsRekrutierend» Google-Maps

ETZ-Elisabeth
5042 AD Tilburg
NetherlandsRekrutierend» Google-Maps

Centrum Medyczne Poznan - PRATIA - PPDS
60-185 Skórzewo
PolandRekrutierend» Google-Maps

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
93-513 Łódź
PolandRekrutierend» Google-Maps

Hospital Garcia de Orta
2801-951 Almada
PortugalRekrutierend» Google-Maps

Centro Hospitalar E Universitário de Coimbra EPE
3000-459 Coimbra
PortugalRekrutierend» Google-Maps

Hospital Senhora da Oliveira - Guimaraes, E.P.E
4830-044 Guimarães
PortugalRekrutierend» Google-Maps

Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
1649-035 Lisboa
PortugalRekrutierend» Google-Maps

Hospital Beatriz Angelo
2674-514 Loures
PortugalRekrutierend» Google-Maps

Unidade Local de Saúde de Matosinhos SA
4454-509 Matosinhos
PortugalRekrutierend» Google-Maps

Centro Hospitalar do Porto EPE
4099-001 Porto
PortugalRekrutierend» Google-Maps

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
4200-072 Porto
PortugalRekrutierend» Google-Maps

Fundeni Clinical Institute
022328 București
RomaniaRekrutierend» Google-Maps

Cardiomed SRL
400015 Cluj-Napoca
RomaniaRekrutierend» Google-Maps

Prof Dr I Chiricuta Institute of Oncology - PPDS
400015 Cluj-Napoca
RomaniaRekrutierend» Google-Maps

Medisprof SRL
400641 Cluj-Napoca
RomaniaRekrutierend» Google-Maps

Onco Clinic Consult SA
200094 Craiova
RomaniaRekrutierend» Google-Maps

Oncology Center Sfantul Nectarie
200347 Craiova
RomaniaRekrutierend» Google-Maps

Institutul Regional de Oncologie Iasi
700483 Iasi
RomaniaRekrutierend» Google-Maps

Institute for Oncology and Radiology of Serbia - PPDS
11000 Belgrade
SerbiaRekrutierend» Google-Maps

Military Medical Academy
11000 Belgrade
SerbiaRekrutierend» Google-Maps

University Clinical Center of Serbia - PPDS
11000 Belgrade
SerbiaRekrutierend» Google-Maps

Clinical Hospital Center Bezanijska Kosa
11070 Belgrade
SerbiaRekrutierend» Google-Maps

University Clinical Center Nis
18000 Niš
SerbiaRekrutierend» Google-Maps

Oncology Institute of Vojvodina
21204 Sremska Kamenica
SerbiaRekrutierend» Google-Maps

Oncocare Cancer Centre
119074 Singapore
SingaporeRekrutierend» Google-Maps

National Cancer Center Singapore
258500 Singapore
SingaporeRekrutierend» Google-Maps

Curie Oncology
329563 Singapore
SingaporeRekrutierend» Google-Maps

Cape Town Oncology Trials
7570 Cape Town
South AfricaRekrutierend» Google-Maps

Southern Cross Research South Africa (PTY) LTD
1724 Mogale City
South AfricaZurückgezogen» Google-Maps

University of Pretoria
0181 Pretoria
South AfricaRekrutierend» Google-Maps

Wilgers Oncology Centre
0184 Pretoria
South AfricaRekrutierend» Google-Maps

Corporacio Sanitaria Parc Tauli
08208 Sabadell
SpainRekrutierend» Google-Maps

Complejo Hospitalario de Navarra
31008 Pamplona
SpainRekrutierend» Google-Maps

Hospital Universitario Germans Trias i Pujol
8915 Badalona
SpainRekrutierend» Google-Maps

Hospital Universitario Vall d'Hebron - PPDS
08035 Barcelona
SpainRekrutierend» Google-Maps

Hospital Universitari de Girona Dr Josep Trueta
17007 Girona
SpainRekrutierend» Google-Maps

ICO l'Hospitalet - Hospital Duran i Reynals
08908 L'Hospitalet de Llobregat
SpainRekrutierend» Google-Maps

Hospital Universitario Ramon y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps

Hospital Universitario 12 de Octubre
28041 Madrid
SpainZurückgezogen» Google-Maps

Hospital Universitario La Paz - PPDS
28046 Madrid
SpainRekrutierend» Google-Maps

Hospital Regional Universitario de Malaga - Hospital General
29010 Málaga
SpainRekrutierend» Google-Maps

Complejo Asistencial Universitario de Salamanca - H. Clinico
32911 Salamanca
SpainRekrutierend» Google-Maps

Hospital Universitario Marques de Valdecilla
39008 Santander
SpainRekrutierend» Google-Maps

Hospital Universitario Virgen Macarena
41009 Sevilla
SpainRekrutierend» Google-Maps

Hospital Clinico Universitario de Valencia
46010 Valencia
SpainRekrutierend» Google-Maps

Hospital Universitario Miguel Servet
50009 Zaragoza
SpainRekrutierend» Google-Maps

China Medical University Hospital
404472 Taichung
TaiwanRekrutierend» Google-Maps

Chi Mei Medical Center
71004 Tainan
TaiwanRekrutierend» Google-Maps

Mackay Memorial Hospital
104 Taipei
TaiwanRekrutierend» Google-Maps

Taipei Veterans General Hospital
11217 Taipei
TaiwanRekrutierend» Google-Maps

Siriraj Hospital Mahidol University
10700 Bangkok Noi
ThailandRekrutierend» Google-Maps

Bangkok Metropolitan Administration Medical College and Vajira Hospital
10300 Bangkok
ThailandRekrutierend» Google-Maps

Phramongkutklao Hospital
10400 Bangkok
ThailandRekrutierend» Google-Maps

Prince of Songkla University
90110 Hat Yai
ThailandRekrutierend» Google-Maps

Srinagarind Hospital, Khon Kaen University
40000 Khon Kaen
ThailandRekrutierend» Google-Maps

Chulaborn Hospital
10210 Lak Si
ThailandRekrutierend» Google-Maps

Naresuan University
65000 Phitsanulok
ThailandRekrutierend» Google-Maps

Istanbul Universitesi Cerrahpasa Tip Fakultesi
34098 Fatih
TurkeyNoch nicht rekrutierend» Google-Maps

Hacettepe Universitesi Kanser Enstitusu
06230 Ankara
TurkeyRekrutierend» Google-Maps

Akdeniz University Medical Faculty
07070 Antalya
TurkeyRekrutierend» Google-Maps

Antalya Yaşam Onkoloji Merkezi
07300 Antalya
TurkeyRekrutierend» Google-Maps

Research site
Balçova
TurkeyNoch nicht rekrutierend» Google-Maps

Uludag Universites Tip Fakultesi Hastanesi
16059 Bursa
TurkeyRekrutierend» Google-Maps

Research site
Denizli
TurkeyNoch nicht rekrutierend» Google-Maps

Dicle University Medical Faculty
21100 Diyarbakir
TurkeyRekrutierend» Google-Maps

Trakya University Medical Faculty
22030 Edirne
TurkeyRekrutierend» Google-Maps

Research site
Fatih
TurkeyNoch nicht rekrutierend» Google-Maps

Dokuz Eylul Universitesi
35220 Izmir
TurkeyRekrutierend» Google-Maps

Acibadem Maslak Hospital
34457 Sariyer
TurkeyRekrutierend» Google-Maps

Acibadem Adana Hospital
01130 Seyhan
TurkeyRekrutierend» Google-Maps

Research site
Sur
TurkeyNoch nicht rekrutierend» Google-Maps

Research site
Tarabya
TurkeyNoch nicht rekrutierend» Google-Maps

Medical Park Trabzon Yildizli
61310 Trabzon
TurkeyRekrutierend» Google-Maps

Research site
Yenimahalle
TurkeyNoch nicht rekrutierend» Google-Maps

Research site
Çankaya
TurkeyNoch nicht rekrutierend» Google-Maps

Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS
49102 Dnipropetrovsk
UkraineAktiv, nicht rekrutierend» Google-Maps

Communal Non-profit Enterprise Regional Center of Oncology
61070 Kharkiv
UkraineZurückgezogen» Google-Maps

MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
50048 Kryvyi Rih
UkraineAktiv, nicht rekrutierend» Google-Maps

Medical Center of Limited Liability Company "Medical center "VERUM EXPERT"
03039 Kyiv
UkraineZurückgezogen» Google-Maps

Treatment and Diagnostic Center of LLC Specialized Clinic Prognosis Optima
03126 Kyiv
UkraineZurückgezogen» Google-Maps

SI "National Institute of Surgery and Transplantology n.a. O.O. Shalimov " of NAMS of Ukraine
03680 Kyiv
UkraineZurückgezogen» Google-Maps

Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center
3115 Kyiv
UkraineZurückgezogen» Google-Maps

The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council
43018 Lutsk
UkraineAktiv, nicht rekrutierend» Google-Maps

Municipal Non-profit Enterprise "Odessa Regional Oncology Dispensary" of Odesa RC
65055 Odesa
UkraineAktiv, nicht rekrutierend» Google-Maps

Bristol Haematology and Oncology Centre
BS2 8ED Bristol
United KingdomRekrutierend» Google-Maps

Western General Hospital Edinburgh - PPDS
EH4 2XU Edinburgh
United KingdomRekrutierend» Google-Maps

St James University Hospital
LS9 7TF Leeds
United KingdomRekrutierend» Google-Maps

Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
SE1 9RT London
United KingdomRekrutierend» Google-Maps

Royal Marsden Hospital - London
SW7 3RP London
United KingdomRekrutierend» Google-Maps

Royal Marsden Hospital - Surrey
SW7 3RP London
United KingdomRekrutierend» Google-Maps

Mount Vernon Hospital
HA6 2RN Northwood
United KingdomRekrutierend» Google-Maps

Edith Cavell Hospital
PE3 9GZ Peterborough
United KingdomRekrutierend» Google-Maps

Weston Park Cancer Centre
S10 2SJ Sheffield
United KingdomRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

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)

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)

Studien-Rationale

Primary outcome:

1. Progression-free survival (PFS) by blinded independent central review (BICR) (Time Frame - Up to 2.5 years):
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 BICR or death from any cause

2. Overall survival (Time Frame - Up to 3.5 years):
The time from randomization to death due to any cause

Secondary outcome:

1. Confirmed objective response rate (ORR) by BICR (Time Frame - Up to 2.5 years):
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

2. Duration of response (DOR) by BICR (Time Frame - Up to 2.5 years):
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

3. PFS per Investigator assessment (Time Frame - Up to 2.5 years):
The time from randomization to the date of documented disease progression (per RECIST 1.1) as assessed by Investigator or death from any cause

4. Confirmed ORR per Investigator assessment (Time Frame - Up to 2.5 years):
Number of patients who achieved a best overall response of CR or PR as determined per RECIST 1.1 as assessed by Investigator

5. DOR per Investigator assessment (Time Frame - Up to 2.5 years):
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

6. Incidence of adverse events (Time Frame - Up to 2 years):
Number of subjects who experienced adverse events or serious adverse events

7. Incidence of clinical laboratory abnormalities (Time Frame - Up to 2 years):
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

8. 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) (Time Frame - Up to 2.5 years):
Changes from baseline in the EORTC QLQ-C30 scores

9. HRQoL as assessed by the EORTC Quality of Life Questionnaire (oesophago-gastric module) OG25 (QLQ-OG25) (Time Frame - Up to 2.5 years):
Changes from baseline in the EORTC QLQ-OG25 scores

10. HRQoL as assessed by the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire (Time Frame - Up to 2.5 years):
Changes from baseline in the EORTC EQ-5D-5L questionnaire scores

11. Serum concentration of zanidatamab and tislelizumab (Time Frame - Up to 2 years)

12. Incidence of anti-drug antibodies (ADAs) (Time Frame - Up to 2 years):
Number of patients who develop ADAs

Studien-Arme

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

Geprüfte Regime

Zanidatamab (ZW25 / JZP598 / ):
Administered IV
Tislelizumab:
Administered IV
Trastuzumab (Herceptin®):
Administered intravenously (IV)
Capecitabine:
Administered orally (PO bid)
Oxaliplatin:
Administered IV
Cisplatin:
Administered IV
5-Fluorouracil:
Administered IV

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!