Esophageal Adenocarcinoma Clinical Trial
— HERIZON-GEA-01Official 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)
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).
Status | Recruiting |
Enrollment | 918 |
Est. completion date | July 1, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital de Gastroenterología Dr Bonorino Udaondo | Buenos Aires | |
Argentina | Hospital Italiano de Buenos Aires | Buenos Aires | |
Argentina | Instituto de Investigaciones Metabólicas - IDIM | Ciudad Autónoma de Buenos Aires | |
Argentina | Centro Médico Privado CEMAIC | Córdoba | |
Argentina | Fundación Centro de Medicina Nuclear y Molecular ER | Córdoba | |
Argentina | Centro de Investigación Pergamino S.A. | Pergamino | |
Argentina | Centro de Investigaciones Médicas Tucumán | San Miguel De Tucumán | |
Argentina | Centro de Investigación Clínica - Clínica Viedma | Viedma | |
Australia | Border Medical Oncology Research Unit | Albury | |
Australia | Flinders Medical Centre | Bedford Park | |
Australia | Austin Health | Heidelberg | |
Australia | Liverpool Hospital | Liverpool | |
Australia | Fiona Stanley Hospital | Murdoch | |
Belgium | Imelda VZW | Bonheiden | |
Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
Belgium | UZ Gent | Gent | |
Belgium | UZ Leuven | Leuven | |
Belgium | CHU de Liège | Liège | |
Brazil | Centro Integrado de Pesquisa - CIP | Barretos | |
Brazil | Fundação Pio XII Hospital de Câncer de Barretos | Barretos | |
Brazil | Cenantron - Centro Avancado de Tratamento Oncologico Ltda | Belo Horizonte | |
Brazil | Centro de Pesquisas Clínicas/Fundação Doutor Amaral Carvalho | Brasília | |
Brazil | Instituto Do Câncer Do Ceará ICC | Fortaleza | |
Brazil | ONCOSITE Centro de Pesquisa Clínica Em Oncologia | Ijuí | |
Brazil | Hospital de Clinicas de Porto Alegre (HCPA) - PPDS | Porto Alegre | |
Brazil | Hospital Nossa Senhora Da Conceição | Porto Alegre | |
Brazil | Hospital Sao Lucas da PUCRS | Porto Alegre | |
Brazil | Irmandade Da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | |
Brazil | INCA - Instituto Nacional de Câncer José Alencar G | Rio De Janeiro | |
Brazil | Núcleo de Pesquisa Clínica da Rede São Camilo | Santo André | |
Brazil | Instituto do Cancer do Estado de São Paulo ICESP | São Paulo | |
Brazil | Instituto de Oncologia de Sorocaba | Sorocaba | |
Canada | Princess Margaret Cancer Centre | Toronto | |
Chile | Corporacion de Beneficencia Osorno | Osorno | |
Chile | Centro de Estudios Clínicos SAGA SpA | Providencia | |
Chile | Fundación Arturo López Pérez (FALP) - PPDS | Providencia | Región-Metropolitana De Santiago |
Chile | Meditek Ltda | Recoleta | |
Chile | BIOCINETIC SpA | Santiago | |
Chile | Icegclinic | Santiago | |
Chile | Sociedad Oncovida S.A | Santiago | |
Chile | Sociedad de Investigaciones Medicas Limitada | Temuco | |
China | Beijing Cancer Hospital | Beijing | |
China | Beijing Chao-Yang Hospital, Capital Medical University | Beijing | |
China | Beijing Hospital | Beijing | |
China | Beijing Luhe Hospital, Capital Medical University | Beijing | |
China | Beijing Tiantan Hospital, Capital Medical University | Beijing | |
China | Cancer Hospital Chinese Academy of Medical Sciences | Beijing | |
China | Peking Union Medical College Hospital | Beijing | |
China | Peking University Third Hospital | Beijing | |
China | The First Affiliated Hospital of Bengbu Medical College | Bengbu | |
China | Hunan Cancer Hospital | Changsha | |
China | Changzhi People's Hospital | Changzhi | |
China | Changzhou First People's Hospital | Changzhou | |
China | Sichuan Cancer Hospital & Institute | Chengdu | |
China | Foshan First People's Hospital | Foshan | |
China | Fujian Cancer Hospital | Fuzhou | |
China | The First Affiliated Hospital of Fujian Medical University | Fuzhou | |
China | Guangdong Provincial People's Hospital | Guangzhou | |
China | The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | |
China | Hainan General Hospital | Haikou | |
China | Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | |
China | Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | |
China | The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | |
China | Zhejiang Cancer Hospital | Hangzhou | |
China | Harbin Medical University Cancer Hospital | Harbin | |
China | Anhui Provincial Cancer Hospital | Hefei | |
China | The Second Affiliated Hospital of Anhui Medical University | Hefei | |
China | Affiliated Hospital of Inner Mongolia Medical University | Hohhot | |
China | Jinan Central Hospital | Jinan | |
China | Shandong Cancer Hospital | Jinan | |
China | Yunnan Cancer Hospital | Kunming | |
China | Gansu Cancer Hospital | Lanzhou | |
China | The First Hospital of Lanzhou University | Lanzhou | |
China | The First Affiliated Hospital of Nanchang University | Nanchang | |
China | Nanjing Drum Tower Hospital ,The Affiliated Hospital of Nanjing University Medical School | Nanjing | |
China | The Affiliated Hospital of Qingdao University | Qingdao | |
China | Fudan University Affiliated Zhongshan Hospital | Shanghai | |
China | Fudan University Shanghai Cancer Center | Shanghai | |
China | Research Site 1 | Shanghai | |
China | Research Site 2 | Shanghai | |
China | Ruijin hospital Shanghai Jiao Tong University School of Medicine | Shanghai | |
China | Shanghai 10th People's Hospital | Shanghai | |
China | Shanghai East Hospital | Shanghai | |
China | Shanghai General Hospital | Shanghai | |
China | Shangrao People's Hospital | Shangrao | |
China | Liaoning Cancer Hospital & Institute | Shenyang | |
China | The First Hospital of China Medical University | Shenyang | |
China | Peking University Shenzhen Hospital | Shenzhen | |
China | Research Site | Shenzhen | |
China | Shenzehen People's Hospital | Shenzhen | |
China | The Fourth Hospital of Hebei Medical University | Shijiazhuang | |
China | Tianjin Medical University Cancer Institute & Hospital | Tianjin | |
China | Tianjin Medical University General Hospital | Tianjin | |
China | The Tonghua Central Hospital | Tonghua | |
China | Cancer Hospital affiliated to Xinjiang Medical University | Ürümqi | |
China | Weihai Municipal Hospital | Weihai | |
China | The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | |
China | Hubei Cancer Hospital | Wuhan | |
China | Union Hospital Tongji Medical College HuaZhong University of Science and Technology | Wuhan | |
China | Affiliated Hospital of Jiangnan University | Wuxi | |
China | First Affiliated Hospital of Xi 'an Jiaotong University | Xi'an | |
China | The First Affiliated Hospital of Xiamen University | Xiamen | |
China | Northern Jiangsu People's Hospital | Yangzhou | |
China | Henan Cancer Hospital | Zhengzhou | |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | |
Czechia | Fakultni nemocnice Olomouc | Hradec Králové | |
Estonia | East Tallinn Central Hospital | Tallinn | |
Estonia | North Estonia Medical Centre Foundation | Tallinn | |
France | Sainte-Catherine, Institut du Cancer Avignon Provence | Avignon | |
France | Hopital Jean Minjoz | Besançon | |
France | EDOG - Institut Bergonie - PPDS | Bordeaux | |
France | Universite de Bourgogne - Faculte de Medecine - IN | Dijon | |
France | Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon | Grenoble | |
France | Centre Léon Berard | Lyon | |
France | EDOG Institut de Cancerologie de l'Ouest - PPDS | Nantes | |
France | CHRU de Poitiers La Miletrie | Poitiers | |
France | EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS | Rennes | |
France | CHRU de Brest - Hopital Morvan | Saint-Priest-en-Jarez | |
France | Hôpital de Rangueil | Toulouse | |
France | Hôpital Saint Antoine | Villejuif | |
Georgia | High Technology Hospital MedCenter Ltd | Tbilisi | |
Georgia | LTD TIM, Tbilisi Institute of Medicine | Tbilisi | |
Georgia | Research Institute of Clinical Medicine | Tbilisi | |
Georgia | Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies | Tbilisi | |
Germany | Institut für Klinisch-Onkologische Forschung | Frankfurt am Main | Hessen |
Germany | Medizinische Hochschule Hannover | Hannover | |
Germany | Universitaetsklinikum Leipzig | Leipzig | |
Germany | Klinikum Mutterhaus der Borromäerinnen | Trier | Rheinland-Pfalz |
Germany | Universitaetsklinikum Ulm | Ulm | |
Greece | Aretaieio Hospital of Athens | Athens | |
Greece | Attikon University General Hospital | Athens | |
Greece | Metaxa Memorial Cancer Hospital Piraeus Dept. ?f Medical Oncology | Peiraias | Attiki |
Greece | Research Site | Piraeus | |
Greece | Agios Loucas Clinic SA | Thessaloniki | |
Greece | Bioclinic Thessaloniki Oncology Department | Thessaloniki | |
Greece | Interbalkan Medical Center of Thessaloniki Oncology Department | Thessaloniki | |
Guatemala | Clinica Medica Especializada CELAN | Guatemala City | |
Guatemala | Grupo Medico Angeles | Guatemala City | |
Guatemala | Integra Cancer Institute | Guatemala City | |
Guatemala | Centro Medico Integral de Cancerologia CEMIC | Salcaja | |
India | The Bangalore Hospital | Bangalore | |
India | All India Institute of Medical Sciences, Bhubaneswar | Bhubaneswar | |
India | Artemis Hospital | Gurgaon | |
India | MNJ Institute of Oncology and Regional Cancer Centre | Hyderabad | |
India | Research Site | Jaipur | |
India | Curie Manavata Cancer Centre | Nashik | |
India | Indraprastha Apollo Hospitals | New Delhi | |
India | Regional Cancer Centre Indira Gandhi Institute of Medical Sciences | Patna | |
India | Deenanath Mangeshkar Hospital and Research Centre | Pune | |
India | HCG City Cancer Center | Vijayawada | |
Ireland | St James's Hospital | Dublin | |
Italy | Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi | Bologna | |
Italy | Fondazione del Piemonte per l'Oncologia (IRCCS) | Candiolo | |
Italy | Ospedale Policlinico San Martino | Genova | |
Italy | Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS | Meldola | |
Italy | ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda | Milano | |
Italy | Istituto Nazionale Dei Tumori | Milano | |
Italy | Ospedale San Raffaele S.r.l. - PPDS | Milano | |
Italy | Azienda Ospedaliero Universitaria Di Modena Policlinico | Modena | |
Italy | Arcispedale Santa Maria Nuova | Reggio Emilia | |
Italy | Fondazione Policlinico Universitario A Gemelli | Rome | |
Italy | Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | |
Italy | Centro Ricerche Cliniche Di Verona | Verona | |
Italy | Azienda ULSS 8 "Berica" - Ospedale San Bortolo | Vicenza | |
Japan | Hyogo Cancer Center | Akashi-shi | Hyôgo |
Japan | Chiba Cancer Center | Chiba-Shi | Tiba |
Japan | National Cancer Center Hospital | Chuo Ku | |
Japan | Kumamoto University Hospital - Honjo-Kuhonji Campus A | Chuo-Ku | Kumamoto |
Japan | Fukui Prefectural Hospital | Fukui-shi | Hukui |
Japan | National Hospital Organization Kyushu Cancer Center | Fukuoka-shi | |
Japan | Gifu University Hospital | Gifu-Shi | Gihu |
Japan | Kansai Medical University Hospital | Hirakata | Osaka |
Japan | Saitama Cancer Center | Ina | |
Japan | Ibaraki Prefectural Central Hospital | Kasama-Shi | Ibaraki |
Japan | National Cancer Center Hospital East | Kashiwa-shi | Tiba |
Japan | Kagawa University Hospital | Kita-Gun Miki-Cho | Kagawa |
Japan | Kobe City Medical Center General Hospital | Kobe-Shi Chuo-Ku | Hyôgo |
Japan | Kurashiki Central Hospital | Kurashiki-Shi | Okayama |
Japan | Shikoku Cancer Center | Matsuyama | |
Japan | Aichi Cancer Center | Nagoya shi | |
Japan | Niigata Cancer Center Hospital | Niigata-shi | |
Japan | Osaka International Cancer Institute | Osaka | |
Japan | Kindai University Hospital | Osaka-sayama | |
Japan | Osaki Citizen Hospital | Osaki-Shi | Miyagi |
Japan | Gunma Prefectural Cancer Center | Ota-shi | Gunma |
Japan | Kyoto University Hospital | Sakyo-ku | Kyoto-shi |
Japan | Keio University Hospital | Shinjuku-Ku | Tokyo |
Japan | Shizuoka Cancer Center | Shizuoka | |
Japan | Osaka University Hospital | Suita-Shi | Osaka |
Japan | Osaka Medical and Pharmaceutical University Hospital | Takatsuki-Shi | Osaka |
Japan | The Cancer Institute Hospital of Japanese Foundation For Cancer Research | Tokyo | |
Japan | Kanagawa Cancer Center | Yokohama-Shi Asahi-Ku | Kanagawa |
Japan | Kitasato University Hospital | Yokohama-Shi Minami-Ku | Kanagawa |
Korea, Republic of | Hallym University Sacred Heart Hospital | Anyang-si | |
Korea, Republic of | Dong-A University Hospital | Busan | |
Korea, Republic of | Kyungpook National University Chilgok Hospital | Daegu | |
Korea, Republic of | National Cancer Center | Goyang-si | |
Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
Korea, Republic of | CHA Bundang Medical Center, CHA University | Seongnam-si | |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Gangnam Severance Hospital, Yonsei University Health System | Seoul | |
Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
Korea, Republic of | Korea University Anam Hospital | Seoul | |
Korea, Republic of | Korea University Guro Hospital | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Severance Hospital Yonsei University Health System - PPDS | Seoul | |
Korea, Republic of | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | |
Malaysia | Hospital Pulau Pinang | George Town | |
Malaysia | Pantai Hospital Kuala Lumpur | Kuala Lumpur | |
Malaysia | University Malaya Medical Centre | Kuala Lumpur | |
Malaysia | Sarawak General Hospital | Kuching | |
Malaysia | National Cancer Institute ( Institut Kanser Negara) | Putrajaya | |
Mexico | Clinstile, S.A. de C.V. | Mexico City | |
Mexico | Cryptex Investigación Clínica, S.A. de C.V. | Mexico City | |
Mexico | Health Pharma Professional Research S.A de C.V. | Mexico City | |
Mexico | Hospital Universitario Dr. Jose Eleuterio González | Monterrey | |
Mexico | Centro de Investigacion Clinica de Oaxaca | Oaxaca | |
Netherlands | Catharina Hospital | Eindhoven | |
Netherlands | Universitair Medisch Centrum Groningen | Groningen | |
Netherlands | Leids Universitair Medisch Centrum | Leiden | |
Netherlands | ETZ-Elisabeth | Tilburg | |
Poland | Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Lódz | |
Poland | Centrum Medyczne Poznan - PRATIA - PPDS | Skórzewo | |
Poland | Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie | Warszawa | |
Portugal | Hospital Garcia de Orta | Almada | |
Portugal | Centro Hospitalar E Universitário de Coimbra EPE | Coimbra | |
Portugal | Hospital Senhora da Oliveira - Guimaraes, E.P.E | Guimarães | |
Portugal | Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria | Lisboa | |
Portugal | Hospital Beatriz Angelo | Loures | |
Portugal | Unidade Local de Saúde de Matosinhos SA | Matosinhos | |
Portugal | Centro Hospitalar do Porto EPE | Porto | |
Portugal | Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS | Porto | |
Romania | Fundeni Clinical Institute | Bucure?ti | |
Romania | Cardiomed SRL | Cluj-Napoca | |
Romania | Medisprof SRL | Cluj-Napoca | |
Romania | Prof Dr I Chiricuta Institute of Oncology - PPDS | Cluj-Napoca | |
Romania | Onco Clinic Consult SA | Craiova | |
Romania | Oncology Center Sfantul Nectarie | Craiova | |
Romania | Institutul Regional de Oncologie Iasi | Iasi | |
Serbia | Clinical Hospital Center Bezanijska Kosa | Belgrade | |
Serbia | Institute for Oncology and Radiology of Serbia - PPDS | Belgrade | |
Serbia | Military Medical Academy | Belgrade | |
Serbia | University Clinical Center of Serbia - PPDS | Belgrade | |
Serbia | University Clinical Center Nis | Niš | |
Serbia | Oncology Institute of Vojvodina | Sremska Kamenica | |
Singapore | Curie Oncology | Singapore | |
Singapore | National Cancer Center Singapore | Singapore | |
Singapore | Oncocare Cancer Centre | Singapore | |
South Africa | Cape Town Oncology Trials | Cape Town | |
South Africa | Southern Cross Research South Africa (PTY) LTD | Mogale City | |
South Africa | University of Pretoria | Pretoria | |
South Africa | Wilgers Oncology Centre | Pretoria | |
Spain | Hospital Universitario Germans Trias i Pujol | Badalona | |
Spain | Hospital Universitario Vall d'Hebron - PPDS | Barcelona | |
Spain | Hospital Universitari de Girona Dr Josep Trueta | Girona | |
Spain | Institut Català d'Oncologia (Hospital Duran y Reynals) | L'Hospitalet de Llobregat | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario La Paz - PPDS | Madrid | |
Spain | Hospital Universitario Ramon y Cajal | Madrid | |
Spain | Hospital Regional Universitario de Malaga - Hospital General | Málaga | |
Spain | Complejo Hospitalario de Navarra | Pamplona | Navarra |
Spain | Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona |
Spain | Complejo Asistencial Universitario de Salamanca - H. Clinico | Salamanca | |
Spain | Hospital Universitario Marques de Valdecilla | Santander | |
Spain | Hospital Universitario Virgen Macarena | Sevilla | |
Spain | Hospital Clinico Universitario de Valencia | Valencia | |
Spain | Hospital Universitario Miguel Servet | Zaragoza | |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | Chi Mei Medical Center | Tainan | |
Taiwan | Mackay Memorial Hospital | Taipei | |
Taiwan | Taipei Veterans General Hospital | Taipei | |
Thailand | Phramongkutklao Hospital | Bangkok | |
Thailand | Vajira Hospital | Bangkok | |
Thailand | Siriraj Hospital Mahidol University | Bangkok Noi | |
Thailand | Songklanagarind Hospital | Hat Yai | |
Thailand | Srinagarind Hospital, Khon Kaen University | Khon Kaen | |
Thailand | Chulaborn Hospital | Lak Si | |
Thailand | Naresuan University | Phitsanulok | |
Turkey | Hacettepe Universitesi Kanser Enstitusu | Ankara | |
Turkey | Akdeniz University Medical Faculty | Antalya | |
Turkey | Antalya Yasam Onkoloji Merkezi | Antalya | |
Turkey | Research site | Balçova | |
Turkey | Uludag Universites Tip Fakultesi Hastanesi | Bursa | |
Turkey | Research site | Çankaya | |
Turkey | Research site | Denizli | |
Turkey | Dicle University Medical Faculty | Diyarbakir | |
Turkey | Trakya University Medical Faculty | Edirne | |
Turkey | Istanbul Universitesi Cerrahpasa Tip Fakultesi | Fatih | Istanbul |
Turkey | Research site | Fatih | |
Turkey | Dokuz Eylul Universitesi | Izmir | |
Turkey | Acibadem Maslak Hospital | Sariyer | |
Turkey | Acibadem Adana Hospital | Seyhan | |
Turkey | Research site | Sur | |
Turkey | Research site | Tarabya | |
Turkey | Medical Park Trabzon Yildizli | Trabzon | |
Turkey | Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital | Yenimahalle | |
Ukraine | Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS | Dnipropetrovsk | |
Ukraine | Communal Non-profit Enterprise Regional Center of Oncology | Kharkiv | |
Ukraine | MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council | Kryvyi Rih | |
Ukraine | Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center | Kyiv | |
Ukraine | Medical Center of Limited Liability Company "Medical center "VERUM EXPERT" | Kyiv | |
Ukraine | SI "National Institute of Surgery and Transplantology n.a. O.O. Shalimov " of NAMS of Ukraine | Kyiv | |
Ukraine | Treatment and Diagnostic Center of LLC Specialized Clinic Prognosis Optima | Kyiv | |
Ukraine | The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council | Lutsk | |
Ukraine | Daycare Facility of Dispensary-Polyclinic Department | Odesa | |
United Kingdom | Bristol Haematology and Oncology Centre | Bristol | |
United Kingdom | Western General Hospital Edinburgh - PPDS | Edinburgh | |
United Kingdom | St James University Hospital | Leeds | |
United Kingdom | Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital | London | |
United Kingdom | Royal Marsden Hospital - London | London | |
United Kingdom | Royal Marsden Hospital - Surrey | London | |
United Kingdom | Mount Vernon Hospital | Northwood | |
United Kingdom | Edith Cavell Hospital | Peterborough | |
United Kingdom | Weston Park Cancer Centre | Sheffield |
Lead Sponsor | Collaborator |
---|---|
Jazz Pharmaceuticals | BeiGene, Ltd. |
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czechia, Estonia, France, Georgia, Germany, Greece, Guatemala, India, Ireland, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Serbia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival (PFS) by BICR | 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 | |
Primary | Overall survival | The time from randomization to death due to any cause | Up to 3.5 years | |
Secondary | Confirmed objective response rate (ORR) by BICR | 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 | |
Secondary | Duration of response (DOR) by BICR | 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 | |
Secondary | PFS per Investigator assessment | 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 | |
Secondary | Confirmed ORR per Investigator assessment | 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 | |
Secondary | DOR per Investigator assessment | 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 | |
Secondary | Assessment of Contribution of Components based on Progression-free Survival (PFS) by BICR | 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 | |
Secondary | Assessment of Contribution of Components based on Overall Survival | The time from randomization to death due to any cause | Up to 3.5 years | |
Secondary | Incidence of adverse events | Number of subjects who experienced adverse events or serious adverse events | Up to 2 years | |
Secondary | Incidence of clinical laboratory abnormalities | 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 | |
Secondary | 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) | Changes from baseline in the EORTC QLQ-C30 scores | Up to 2.5 years | |
Secondary | HRQoL as assessed by the EORTC Quality of Life Questionnaire (oesophago-gastric module) OG25 (QLQ-OG25) | Changes from baseline in the EORTC QLQ-OG25 scores | Up to 2.5 years | |
Secondary | HRQoL as assessed by the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire | Changes from baseline in the EORTC EQ-5D-5L questionnaire scores | Up to 2.5 years | |
Secondary | Serum concentration of zanidatamab and tislelizumab | Up to 2 years | ||
Secondary | Incidence of anti-drug antibodies (ADAs) | Number of patients who develop ADAs | Up to 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors
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Phase 2 | |
Completed |
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Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
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Phase 2 | |
Recruiting |
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Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
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Phase 1/Phase 2 | |
Recruiting |
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Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
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Phase 2 | |
Terminated |
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Metabolomic and BH3 Profiling of Esophageal Cancers: Identification of Novel Assessment Methods of Treatment Response for Precision Therapy
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Phase 2 | |
Recruiting |
NCT05530343 -
Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance
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N/A | |
Active, not recruiting |
NCT03539822 -
Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies
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Phase 1/Phase 2 | |
Recruiting |
NCT05902988 -
A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer
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Phase 1/Phase 2 | |
Completed |
NCT01970306 -
Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material
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Phase 2 | |
Recruiting |
NCT06071845 -
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
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N/A | |
Active, not recruiting |
NCT02872116 -
Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
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Phase 3 | |
Terminated |
NCT04089904 -
Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma
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Phase 2 | |
Recruiting |
NCT05177133 -
Anti-PD-1 and CapOx for the First-line Treatment of dMMR Esophagogastric Cancer (AuspiCiOus)
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Phase 2 | |
Recruiting |
NCT02962063 -
Durvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer
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Phase 1/Phase 2 | |
Recruiting |
NCT02606396 -
Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer
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N/A | |
Completed |
NCT02610764 -
Pilot Sudy: Resectable Esophageal Adenocarcinoma and the Relevance of CTC
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N/A | |
Terminated |
NCT00430027 -
Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma
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N/A |