En studie av Zanidatamab i kombination med kemoterapi Plus eller Minus Tislelizumab hos patienter med HER2-positiv avancerad eller metastaserad mag- och matstrupscancer (HERIZON-GEA-01)
19 oktober 2026 uppdaterad av: Jazz Pharmaceuticals
En randomiserad, multicenter, fas 3-studie av Zanidatamab i kombination med kemoterapi med eller utan Tislelizumab i försökspersoner med HER2-positiv, icke-operabelt lokalt avancerat eller metastaserande gastroesofagealt adenokarcinom (GEA)
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).
Studieöversikt
Status
Aktiv, inte rekryterande
Studietyp
Interventionell
Inskrivning (Faktisk)
920
Fas
- Fas 3
Utökad åtkomst
Inte längre tillgänglig utanför den kliniska prövningen.
Se utökad åtkomstpost.
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Buenos Aires, Argentina, C1181ACH
- Hospital Italiano de Buenos Aires
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Buenos Aires, Argentina, 1264
- Hospital de Gastroenterología Dr Bonorino Udaondo
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Buenos Aires, Argentina, C1012
- Instituto de Investigaciones Metabólicas - IDIM
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Córdoba, Argentina, X5000HXL
- Fundación Centro de Medicina Nuclear y Molecular ER
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Córdoba, Argentina, X5008HHW
- Centro Médico Privado CEMAIC
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Pergamino, Argentina, 2700
- Centro de Investigación Pergamino S.A.
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Viedma, Argentina, R8500ACE
- Centro de Investigación Clínica - Clínica Viedma
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Bedford Park, Australien, 5042
- Flinders Medical Centre
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Heidelberg, Australien, 3084
- Austin Health
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Liverpool, Australien, 2170
- Liverpool Hospital
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Murdoch, Australien, 6150
- Fiona Stanley Hospital
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Bonheiden, Belgien, 2820
- Imelda VZW
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Brussels, Belgien, 1200
- Cliniques Universitaires Saint-Luc
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Ghent, Belgien, 9000
- UZ Gent
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Leuven, Belgien, 3000
- UZ Leuven
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Liège, Belgien, 4000
- CHU de Liège
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Barretos, Brasilien, 14784-400
- Centro Integrado de Pesquisa - CIP
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Barretos, Brasilien, 14784-400
- Fundação Pio XII Hospital de Câncer de Barretos
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Belo Horizonte, Brasilien, 30130-090
- Cenantron - Centro Avancado de Tratamento Oncologico Ltda
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Brasília, Brasilien, 70840-901
- Centro de Pesquisas Clínicas/Fundação Doutor Amaral Carvalho
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Fortaleza, Brasilien, 60430-230
- Instituto Do Câncer Do Ceará ICC
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Porto Alegre, Brasilien, 90050-170
- Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
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Porto Alegre, Brasilien, 90050-170
- Irmandade Da Santa Casa de Misericordia de Porto Alegre
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Porto Alegre, Brasilien, 91350-200
- Hospital Nossa Senhora Da Conceição
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Santo André, Brasilien, 09060-650
- Núcleo de Pesquisa Clínica da Rede São Camilo
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Sorocaba, Brasilien, 18030-075
- Instituto de Oncologia de Sorocaba
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São Paulo, Brasilien, 01246-000
- Instituto do Cancer do Estado de São Paulo ICESP
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Providencia, Chile, 7500000
- Centro de Estudios Clínicos SAGA SpA
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Santiago, Chile, 7500000
- Sociedad Oncovida S.A
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Santiago, Chile, 8150513
- Icegclinic
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Santiago, Chile, 8330336
- BIOCINETIC SpA
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Temuco, Chile, 4810469
- Sociedad de Investigaciones Medicas Limitada
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Region Metropolitan
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Santiago, Region Metropolitan, Chile, 8420383
- Centro Internacional de Estudios Clinicos CIEC
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Santiago Metropolitan
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Providencia, Santiago Metropolitan, Chile, 7500000
- Fundación Arturo López Pérez (FALP) - PPDS
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Tallinn, Estland, 13419
- North Estonia Medical Centre Foundation
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Avignon, Frankrike, 84000
- Sainte-Catherine, Institut du Cancer Avignon Provence
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Bordeaux, Frankrike, 33000
- EDOG - Institut Bergonie - PPDS
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Dijon, Frankrike, 21079
- Universite de Bourgogne - Faculte de Medecine - IN
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Grenoble, Frankrike, 38043
- Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon
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Lyon, Frankrike, 69008
- Centre Léon Berard
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Nantes, Frankrike, 44805
- EDOG Institut de Cancerologie de l'Ouest - PPDS
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Poitiers, Frankrike, 86021
- CHRU de Poitiers La Miletrie
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Rennes, Frankrike, 35000
- EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
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Saint-Priest-en-Jarez, Frankrike, 42270
- CHRU de Brest - Hopital Morvan
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Toulouse, Frankrike, 69437
- Hôpital de Rangueil
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Villejuif, Frankrike, 94800
- Hôpital Saint Antoine
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Gironde
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Pessac, Gironde, Frankrike, 33600
- CHU de Bordeaux - Hopital Haut Leveque
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Tbilisi, Georgien, 0112
- Research Institute of Clinical Medicine
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Tbilisi, Georgien, 6000
- High Technology Hospital MedCenter Ltd
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Athens, Grekland, 124 64
- Attikon University General Hospital
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Thessaloniki, Grekland, 552 36
- Agios Loucas Clinic SA
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Thessaloniki, Grekland, 54622
- Bioclinic Thessaloniki Oncology Department
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Thessaloniki, Grekland, 57001
- Interbalkan Medical Center of Thessaloniki Oncology Department
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Guatemala City, Guatemala, 01010
- Clinica Medica Especializada CELAN
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Guatemala City, Guatemala, 01015
- Grupo Medico Angeles
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Salcajá, Guatemala, 09002
- Centro Medico Integral de Cancerologia CEMIC
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Bhubaneswar, Indien, 751019
- All India Institute of Medical Sciences, Bhubaneswar
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Gūrgaon, Indien, 122003
- Artemis Hospital
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Hyderabad, Indien, 500004
- MNJ Institute of Oncology and Regional Cancer Centre
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New Delhi, Indien, 110076
- Indraprastha Apollo Hospitals
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Patna, Indien, 800014
- Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
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Vijayawada, Indien, 520002
- HCG City Cancer Center
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Dublin, Irland, 8
- St James's Hospital
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Bologna, Italien, 40138
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
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Candiolo, Italien, 10060
- Fondazione del Piemonte per l'Oncologia (IRCCS)
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Genova, Italien, 16132
- Ospedale Policlinico San Martino
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Meldola, Italien, 47014
- Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
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Milan, Italien, 20132
- Ospedale San Raffaele S.r.l. - PPDS
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Milan, Italien, 20162
- ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
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Milan, Italien, 20133
- Istituto Nazionale Dei Tumori
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Modena, Italien, 41124
- Azienda Ospedaliero Universitaria Di Modena Policlinico
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Reggio Emilia, Italien, 43100
- Arcispedale Santa Maria Nuova
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Rome, Italien, 00168
- Fondazione Policlinico Universitario A Gemelli
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Verona, Italien, 37134
- Centro Ricerche Cliniche Di Verona
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Vicenza, Italien, 36100
- Azienda ULSS 8 "Berica" - Ospedale San Bortolo
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Chūōku, Japan, 104-0045
- National Cancer Center Hospital
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Fukuoka, Japan, 811-1395
- National Hospital Organization Kyushu Cancer Center
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Ina, Japan, 362-0806
- Saitama Cancer Center
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Matsuyama, Japan, 791-0245
- Shikoku Cancer Center
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Osaka, Japan, 540-0008
- Osaka International Cancer Institute
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Tokyo, Japan, 135-8550
- The Cancer Institute Hospital of Japanese Foundation For Cancer Research
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Ōsaka-sayama, Japan, 589-0014
- Kindai University Hospital
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Chiba
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Chiba, Chiba, Japan, 260-0801
- Chiba Cancer Center
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Kashiwa-shi, Chiba, Japan, 277-8577
- National Cancer Center Hospital East
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Gihu
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Gifu, Gihu, Japan, 501-1112
- Gifu University Hospital
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Gunma
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Ota-shi, Gunma, Japan, 373-8550
- Gunma Prefectural Cancer Center
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Hyôgo
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Akashi-shi, Hyôgo, Japan, 673-8558
- Hyogo Cancer Center
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Ibaraki
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Kasama-Shi, Ibaraki, Japan, 309-1793
- Ibaraki Prefectural Central Hospital
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Kagawa-ken
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Kita-Gun Miki-Cho, Kagawa-ken, Japan, 761-0701
- Kagawa University Hospital
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Kanagawa
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Yokohama-Shi Asahi-Ku, Kanagawa, Japan, 241-0815
- Kanagawa Cancer Center
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Kumamoto
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Chuo-Ku, Kumamoto, Japan, 860-8556
- Kumamoto University Hospital - Honjo-Kuhonji Campus A
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Kyoto-shi
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Sakyo-ku, Kyoto-shi, Japan, 606-8507
- Kyoto University Hospital
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Miyagi
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Osaki-Shi, Miyagi, Japan, 989-6136
- Osaki Citizen Hospital
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Okayama-ken
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Kurashiki-Shi, Okayama-ken, Japan, 710-0052
- Kurashiki Central Hospital
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Osaka
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Suita-Shi, Osaka, Japan, 565-0871
- Osaka University Hospital
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Takatsuki-Shi, Osaka, Japan, 569-8686
- Osaka Medical and Pharmaceutical University Hospital
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Tokyo
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Shinjuku-Ku, Tokyo, Japan, 160-8582
- Keio University Hospital
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Toronto, Kanada, M5G 2C1
- Princess Margaret Cancer Centre
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Beijing, Kina, 100142
- Beijing Cancer Hospital
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Beijing, Kina, 100191
- Peking University Third Hospital
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Beijing, Kina, 100021
- Cancer Hospital Chinese Academy of Medical Sciences
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Beijing, Kina, 101199
- Beijing Luhe Hospital, Capital Medical University
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Beijing, Kina, 100020
- Beijing Chao-Yang Hospital, Capital Medical University
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Bengbu, Kina, 233004
- The First Affiliated Hospital of Bengbu Medical College
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Changsha, Kina, 410031
- Hunan Cancer Hospital
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Changzhi, Kina, 046099
- Changzhi People's Hospital
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Changzhou, Kina, 213004
- Changzhou First People's Hospital
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Chengdu, Kina, 610042
- Sichuan Cancer Hospital & Institute
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Fuzhou, Kina, 350014
- Fujian Cancer Hospital
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Fuzhou, Kina, 350005
- The First Affiliated Hospital of Fujian Medical University
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Guangzhou, Kina, 510655
- The Sixth Affiliated Hospital of Sun Yat-sen University
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Guangzhou, Kina, 510055
- Guangdong Provincial People's Hospital
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Haikou, Kina, 570311
- Hainan General Hospital
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Hangzhou, Kina, 310016
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Hangzhou, Kina, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Kina, 310003
- The First Affiliated Hospital, College of Medicine, Zhejiang University
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Hangzhou, Kina, 310017
- Second Affiliated Hospital of Zhejiang University School of Medicine
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Harbin, Kina, 150081
- Harbin Medical University Cancer Hospital
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Hefei, Kina, 230601
- The Second Affiliated Hospital of Anhui Medical University
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Hefei, Kina, 230031
- Anhui Provincial Cancer Hospital
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Hohhot, Kina, 01000
- Affiliated Hospital of Inner Mongolia Medical University
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Jinan, Kina, 250013
- Jinan Central Hospital
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Jinan, Kina, 250000
- Shandong Cancer Hospital
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Kunming, Kina, 650118
- Yunnan Cancer Hospital
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Lanzhou, Kina, 730050
- Gansu Cancer Hospital
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Lanzhou, Kina, 730013
- The First Hospital of Lanzhou University
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Nanchang, Kina, 330052
- The First Affiliated Hospital of Nanchang University
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Nanjing, Kina, 210008
- Nanjing Drum Tower Hospital ,The Affiliated Hospital of Nanjing University Medical School
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Qingdao, Kina, 266003
- The Affiliated Hospital of Qingdao University
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Shanghai, Kina, 200032
- Fudan University Shanghai Cancer Center
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Shanghai, Kina, 200080
- Shanghai General Hospital
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Shanghai, Kina, 200032
- Fudan University Affiliated Zhongshan Hospital
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Shanghai, Kina, 200025
- Ruijin hospital Shanghai Jiao Tong University School of Medicine
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Shenyang, Kina, 110801
- Liaoning Cancer Hospital & Institute
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Shijiazhuang, Kina, 50011
- The Fourth Hospital of Hebei Medical University
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Tianjin, Kina, 300060
- Tianjin Medical University Cancer Institute & Hospital
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Tianjin, Kina, 300041
- Tianjin Medical University General Hospital
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Tonghua, Kina, 143099
- The Tonghua Central Hospital
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Weihai, Kina, 264200
- Weihai Municipal Hospital
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Wenzhou, Kina, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, Kina, 430079
- Hubei Cancer Hospital
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Wuhan, Kina, 430023
- Union Hospital Tongji Medical College HuaZhong University of Science and Technology
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Wuxi, Kina, 214062
- Affiliated Hospital of Jiangnan University
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Xi'an, Kina, 710061
- First Affiliated Hospital of Xi 'an Jiaotong University
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Xiamen, Kina, 361003
- The First Affiliated Hospital of Xiamen University
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Yangzhou, Kina, 225001
- Northern Jiangsu People's Hospital
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Zhengzhou, Kina, 450052
- The First Affiliated Hospital of Zhengzhou University
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Zhengzhou, Kina, 450003
- Henan Cancer Hospital
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Ürümqi, Kina, 830026
- Cancer Hospital affiliated to Xinjiang Medical University
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George Town, Malaysia, 10990
- Hospital Pulau Pinang
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Kuching, Malaysia, 93586
- Sarawak General Hospital
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Putrajaya, Malaysia, 62675
- National Cancer Institute ( Institut Kanser Negara)
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Mexico City, Mexiko, 03100
- Health Pharma Professional Research S.A de C.V.
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Monterrey, Mexiko, 64460
- Hospital Universitario Dr. Jose Eleuterio González
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Oaxaca City, Mexiko, 68020
- Centro de Investigacion Clinica de Oaxaca
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Eindhoven, Nederländerna, 5623 EJ
- Catharina Hospital
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Leiden, Nederländerna, 2333 ZA
- Leids Universitair Medisch Centrum
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Tilburg, Nederländerna, 5042 AD
- ETZ-Elisabeth
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Lodz, Polen, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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Warsaw, Polen, 02-034
- Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
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Almada, Portugal, 2801-951
- Hospital Garcia de Orta
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Coimbra, Portugal, 3000-459
- Centro Hospitalar E Universitário de Coimbra EPE
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Guimarães, Portugal, 4830-044
- Hospital Senhora da Oliveira - Guimaraes, E.P.E
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Lisbon, Portugal, 1649-035
- Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
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Matosinhos Municipality, Portugal, 4454-509
- Unidade Local de Saúde de Matosinhos SA
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Porto, Portugal, 4200-072
- Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
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Porto, Portugal, 4099-001
- Centro Hospitalar do Porto EPE
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Bucharest, Rumänien, 022328
- Fundeni Clinical Institute
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Cluj-Napoca, Rumänien, 400015
- Prof Dr I Chiricuta Institute of Oncology - PPDS
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Cluj-Napoca, Rumänien, 400641
- Medisprof SRL
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Craiova, Rumänien, 200347
- Oncology Center Sfantul Nectarie
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Belgrade, Serbien, 11070
- Clinical Hospital Center Bezanijska Kosa
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Belgrade, Serbien, 11000
- University Clinical Center of Serbia - PPDS
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Kamenitz, Serbien, 21204
- Oncology Institute of Vojvodina
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Niš, Serbien, 18000
- University Clinical Center Nis
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Singapore, Singapore, 258500
- National Cancer Center Singapore
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Badalona, Spanien, 8915
- Hospital Universitario Germans Trias i Pujol
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Barcelona, Spanien, 08035
- Hospital Universitario Vall d'Hebron - PPDS
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Girona, Spanien, 17007
- Hospital Universitari de Girona Dr Josep Trueta
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L'Hospitalet de Llobregat, Spanien, 08908
- Institut Català d'Oncologia (Hospital Duran y Reynals)
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Madrid, Spanien, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, Spanien, 28046
- Hospital Universitario La Paz - PPDS
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Málaga, Spanien, 29010
- Hospital Regional Universitario de Malaga - Hospital General
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Salamanca, Spanien, 32911
- Complejo Asistencial Universitario de Salamanca - H. Clinico
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Santander, Spanien, 39008
- Hospital Universitario Marques de Valdecilla
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Seville, Spanien, 41009
- Hospital Universitario Virgen Macarena
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Zaragoza, Spanien, 50009
- Hospital Universitario Miguel Servet
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Barcelona
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Sabadell, Barcelona, Spanien, 08208
- Corporacio Sanitaria Parc Tauli
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Navarre
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Pamplona, Navarre, Spanien, 31008
- Complejo Hospitalario de Navarra
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Bristol, Storbritannien, BS2 8ED
- Bristol Haematology and Oncology Centre
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Edinburgh, Storbritannien, EH4 2XU
- Western General Hospital Edinburgh - PPDS
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Leeds, Storbritannien, LS9 7TF
- St James University Hospital
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London, Storbritannien, SE1 9RT
- Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
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London, Storbritannien, SW7 3RP
- Royal Marsden Hospital - London
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London, Storbritannien, SW7 3RP
- Royal Marsden Hospital - Surrey
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Peterborough, Storbritannien, PE3 9GZ
- Edith Cavell Hospital
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Sheffield, Storbritannien, S10 2SJ
- Weston Park Cancer Centre
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Pretoria, Sydafrika, 0184
- Wilgers Oncology Centre
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Anyang-si, Sydkorea, 14068
- Hallym University Sacred Heart Hospital
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Busan, Sydkorea, 49201
- Dong-A University Hospital
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Daegu, Sydkorea, 41404
- Kyungpook National University Chilgok Hospital
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Goyang-si, Sydkorea, 10408
- National Cancer Center
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Incheon, Sydkorea, 21565
- Gachon University Gil Medical Center
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Seongnam-si, Sydkorea, 13620
- Seoul National University Bundang Hospital
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Seongnam-si, Sydkorea, 13496
- CHA Bundang Medical Center, CHA University
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Seoul, Sydkorea, 03080
- Seoul National University Hospital
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Seoul, Sydkorea, 05505
- Asan Medical Center
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Seoul, Sydkorea, 06351
- Samsung Medical Center
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Seoul, Sydkorea, 03181
- Kangbuk Samsung Hospital
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Seoul, Sydkorea, 02841
- Korea University Anam Hospital
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Seoul, Sydkorea, 08308
- Korea University Guro Hospital
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Seoul, Sydkorea, 03080
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Sydkorea, 03686
- Severance Hospital Yonsei University Health System - PPDS
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Seoul, Sydkorea, 06229
- Gangnam Severance Hospital, Yonsei University Health System
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Taichung, Taiwan, 404472
- China Medical University Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Hat Yai, Thailand, 90110
- Songklanagarind Hospital
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Khon Kaen, Thailand, 40000
- Srinagarind Hospital, Khon Kaen University
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Lak Si, Thailand, 10210
- Chulaborn Hospital
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Ankara, Turkiet (Türkiye), 06230
- Hacettepe Universitesi Kanser Enstitusu
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Edirne, Turkiet (Türkiye), 22030
- Trakya University Medical Faculty
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Izmir, Turkiet (Türkiye), 35220
- Dokuz Eylul Universitesi
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Seyhan, Turkiet (Türkiye), 01130
- Acibadem Adana Hospital
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Trabzon, Turkiet (Türkiye), 61310
- Medical Park Trabzon Yildizli
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Yenimahalle, Turkiet (Türkiye), 06200
- Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital
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Hesse
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Frankfurt am Main, Hesse, Tyskland, 60488
- Institut für Klinisch-Onkologische Forschung
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Dnipropetrovsk, Ukraina, 49102
- Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Arm A
Trastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP) |
Administered intravenously (IV)
Andra namn:
Administered orally (PO bid) Administered IV Administered IV Administered IV |
|
Experimentell: Arm B
Zanidatamab plus physician's choice of CAPOX or FP |
Administered orally (PO bid) Administered IV Administered IV Administered IV Administered IV
Andra namn:
|
|
Experimentell: Arm C
Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP |
Administered orally (PO bid) Administered IV Administered IV Administered IV Administered IV
Andra namn:
Administered IV |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-free survival (PFS) by BICR
Tidsram: 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 blinded independent central review (BICR) or death from any cause |
Up to 2.5 years
|
|
Overall survival
Tidsram: Up to 3.5 years
|
The time from randomization to death due to any cause |
Up to 3.5 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Serumkoncentration av zanidatamab och tislelizumab
Tidsram: Upp till 2 år
|
Upp till 2 år
|
|
|
Confirmed objective response rate (ORR) by BICR
Tidsram: 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 |
Up to 2.5 years
|
|
Duration of response (DOR) by BICR
Tidsram: 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 |
Up to 2.5 years
|
|
PFS per Investigator assessment
Tidsram: 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 |
Up to 2.5 years
|
|
Confirmed ORR per Investigator assessment
Tidsram: 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 |
Up to 2.5 years
|
|
DOR per Investigator assessment
Tidsram: 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 |
Up to 2.5 years
|
|
Assessment of Contribution of Components based on Progression-free Survival (PFS) by BICR
Tidsram: 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 blinded independent central review (BICR) or death from any cause |
Up to 2.5 years
|
|
Assessment of Contribution of Components based on Overall Survival
Tidsram: Up to 3.5 years
|
The time from randomization to death due to any cause |
Up to 3.5 years
|
|
Incidence of adverse events
Tidsram: Up to 2 years
|
Number of subjects who experienced adverse events or serious adverse events |
Up to 2 years
|
|
Incidence of clinical laboratory abnormalities
Tidsram: 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 |
Up to 2 years
|
|
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)
Tidsram: Up to 2.5 years
|
Changes from baseline in the EORTC QLQ-C30 scores |
Up to 2.5 years
|
|
HRQoL as assessed by the EORTC Quality of Life Questionnaire (oesophago-gastric module) OG25 (QLQ-OG25)
Tidsram: Up to 2.5 years
|
Changes from baseline in the EORTC QLQ-OG25 scores |
Up to 2.5 years
|
|
HRQoL as assessed by the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire
Tidsram: Up to 2.5 years
|
Changes from baseline in the EORTC EQ-5D-5L questionnaire scores |
Up to 2.5 years
|
|
Incidence of anti-drug antibodies (ADAs)
Tidsram: Up to 2 years
|
Number of patients who develop ADAs |
Up to 2 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Tabernero J, Shen L, Elimova E, Ku G, Liu T, Shitara K, Lin X, Boyken L, Li H, Grim J, Ajani J. HERIZON-GEA-01: Zanidatamab + chemo +/- tislelizumab for 1L treatment of HER2-positive gastroesophageal adenocarcinoma. Future Oncol. 2022 Sep;18(29):3255-3266. doi: 10.2217/fon-2022-0595. Epub 2022 Aug 24.
- Lee KW, Bai LY, Jung M, Ying J, Im YH, Oh DY, Cho JY, Oh SC, Chao Y, Kim JW, Chen Y, Li V, Chen S, Kang YK. Phase Ib/II Study of Zanidatamab in Combination with Tislelizumab and Chemotherapy in First-Line HER2-Positive Gastric/Gastroesophageal Junction Adenocarcinoma. Clin Cancer Res. 2026 Jan 16;32(2):312-323. doi: 10.1158/1078-0432.CCR-24-4295.
- Yu J, Mehta R. Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257036. doi: 10.6004/jnccn.2025.7036.
- Shitara K, Elimova E, Liu T, Tabernero J, Lee KW, Schenker M, Tebbutt NC, Ajani J, Salimin N, Ku G, Gwang Kim J, Ales Diaz I, Zhang J, Pietrantonio F, Bai LY, Le Sourd S, Zhao J, Hierro C, Kiberu A, Van Herpe F, Bao Y, Zhang H, Yang L, Li V, Gartner EM, Chen Y, Grim J, Rha SY, Shen L; HERIZON-GEA-01 Investigators. Zanidatamab with and without Tislelizumab in HER2-Positive Gastroesophageal Cancer. N Engl J Med. 2026 May 28;394(20):2002-2014. doi: 10.1056/NEJMoa2517729.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
2 december 2021
Primärt slutförande (Faktisk)
15 juli 2026
Avslutad studie (Beräknad)
30 september 2027
Studieregistreringsdatum
Först inskickad
5 november 2021
Först inskickad som uppfyllde QC-kriterierna
3 december 2021
Första postat (Faktisk)
9 december 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 oktober 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 oktober 2026
Senast verifierad
1 oktober 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Magsjukdomar
- Neoplasmer i huvud och hals
- Esofagussjukdomar
- Neoplasmer i magen
- Esofagusneoplasmer
- Parkinsons sjukdom 4, autosomal dominerande Lewy -kropp
- Adenocarcinom i matstrupen
- Aminosyror, peptider och proteiner
- Proteiner
- Organiska kemikalier
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Nukleinsyror, nukleotider och nukleosider
- Antikroppar, monoklonal, humaniserad
- Antikroppar, monoklonal
- Antikroppar
- Immunglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Oorganiska kemikalier
- Klorföreningar
- Kväveföreningar
- Koordinationskomplex
- Deoxycytidin
- Cytidin
- Pyrimidin nukleosider
- Pyrimidiner
- Nukleosider
- Uracil
- Pyrimidinoner
- Platinaföreningar
- Deoxyribonukleosider
- Trastuzumab
- Capecitabin
- Oxaliplatin
- Fluorouracil
- Cisplatin
- zanidatamab
- tislelizumab
Andra studie-ID-nummer
- ZWI-ZW25-301
- 2021-000296-36 (EudraCT-nummer)
- jRCT2061230026 (Registeridentifierare: Japan Registry for Clinical Trials (jRCT))
- 2023-510319-20-00 (Ctis)
- 2023 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .