Zolbetuximab治疗胃和胃食管交界（GEJ）腺癌的临床试验研究

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试验详情

一、临床试验项目名称
Zolbetuximab治疗胃和胃食管交界（GEJ）腺癌的临床试验研究

二、适应症
Zolbetuximab拟开发与铂类和氟尿嘧啶类为基础的化疗联合，用于局部晚期不可切除或转移性、CLDN18.2阳性和HER2阴性的成人胃和胃食管交界（GEJ）腺癌患者的一线治疗。

三、试验介绍

在Claudin（CLDN）18.2阳性、人表皮生长因子受体2（HER2）阴性的局部晚期不可切除或转移性胃和胃食管交界处（GEJ）腺癌受试者中，通过测量无进展生存期（PFS）来比较Zolbetuximab（IMAB362）+mFOLFOX6与安慰剂+mFOLFOX6（作为一线治疗）的有效性以及总生存期（OS），客观缓解率（ORR），缓解持续时间（DOR），安全性和耐受性，HRQoL，药代动力学和免疫原性

研究中心所在省份及城市（具体启动情况以后期咨询为准）

研究中心	主要研究者
中国人民解放军第三O七医院	徐建明

序号	机构名称	主要研究者	国家	省（州）	城市
1	中国人民解放军第三O七医院	徐建明	中国	北京市	北京市
2	哈尔滨医科大学附属肿瘤医院	白玉贤	中国	黑龙江省	哈尔滨市
3	南京大学医学院附属鼓楼医院	魏嘉	中国	江苏省	南京市
4	浙江大学医学院附属第一医院	徐农	中国	浙江省	杭州市
5	郑州大学第一附属医院	樊青霞	中国	河南省	郑州市
6	复旦大学医学院附属中山医院	刘天舒	中国	上海市	上海市
7	安徽医科大学附属第一医院	顾康生	中国	安徽省	合肥市
8	Inova Schar Cancer Institute - Medical Oncology	Timothy Cannon	UNITED STATES	Virginia	Fairfax
9	Health Partners Institute	Daniel Anderson	UNITED STATES	Minnesota	Saint Louis Park
10	Stony Brook University Cancer Clinical Trials	Minsig Choi	UNITED STATES	New York	Stony Brook
11	Seattle Cancer Care Alliance	Veena Shankaran	UNITED STATES	Washington	Seattle
12	Icahn School of Medicine at Mount Sinai	Celina Ang	UNITED STATES	New York	New York
13	University of California Davis Comprehensive Cancer Center - Division of Hematology and Oncology	Edward Kim	UNITED STATES	California	Sacramento
14	University Of Arizona Cancer Center At Dignity Health St.Jos	Mital Patel	UNITED STATES	Arizona	Phoenix
15	Karmanos Cancer Institute	Anthony Shields	UNITED STATES	Michigan	Detroit
16	Lancaster General Hospital	Nandi Reddy	UNITED STATES	Pennsylvania	Lancaster
17	Norton Cancer Institute, Audubon	Michael Driscoll	UNITED STATES	Kentucky	Louisville
18	Roswell Park Cancer Institute	Christos FountzilasUNITED STATES	UNITED STATES	New York	Buffalo
19	Pacific Shores Medical Group - Long Beach	Danny Nguyen	UNITED STATES	California	Long Beach
20	UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay - Gastrointestinal Oncology	Andrew Ko	UNITED STATES	California	San Francisco
21	City of Hope Comprehensive Breast Cancer Center	Joseph Chao	UNITED STATES	California	Duarte
22	Eastern Regional Medical Center Inc	Arturo Loaiza-Bonilla	UNITED STATES	Pennsylvania	Pennsylvania
23	Oregon Health and Science University Knight Cancer Institute	Adel Kardosh	UNITED STATES	Oregon	Portland
24	Loma Linda University	Chung-Tsen Hsueh	UNITED STATES	California	Loma Linda
25	Earle A. Chiles Research Institute	Gina Vaccaro	UNITED STATES	Oregon	Portland
26	University of Arizona Cancer Center - North Campus	Aaron Scott	UNITED STATES	Arizona	Tucson
27	The Ohio State University Comprehensive Cancer Center	Anne Noonan	UNITED STATES	Ohio	Columbus
28	Thomas Jefferson - Sidney Kimmel Cancer Center	James Posey	UNITED STATES	Pennsylvania	Philadelphia
29	Western Regional Medical Center, Inc.	Saba Radhi	UNITED STATES	Arizona	Goodyear
30	Southeastern Regional Medical Center	Eyal Meiri	UNITED STATES	Georgia	Newnan
31	Cedars-Sinai Medical Center	Kristopher Wentzel	UNITED STATES	California	Los Angeles
32	Toledo Clinic Cancer Center - Toledo	Rex Mowat	UNITED STATES	Ohio	Toledo
33	Sanford Cancer Center - Oncology Clinic	Jonathan Bleeker	UNITED STATES	South Dakota	Sioux Falls
34	The University of Texas - MD Anderson Cancer Center - Gastrointestinal Oncology	Jaffer Ajani	UNITED STATES	Texas	Houston
35	University of Oklahoma Health Sciences Center	Sagila George	UNITED STATES	Oklahoma	Oklahoma City
36	Precision Cancer Research/Dayton Physicians Network - Treatment	Charles Bane	UNITED STATES	Ohio	Kettering
37	University Of Chicago Medical Center	Daniel Catenacci	UNITED STATES	Illinois	Chicago
38	Sylvester Comprehensive Cancer Center - Oncology Services	Albert Lockhart	UNITED STATES	Florida	Miami
39	The Valley Hospital Luckow Pavilion	Kevin Wood	UNITED STATES	New Jersey	Paramus
40	Northwestern University Medical School - Hematology, Oncology	Mary Mulcahy	UNITED STATES	Illinois	Chicago
41	Maryland Oncology Hematology	Jun Sun	UNITED STATES	Maryland	Clinton
42	University of Maryland School of Medicine - Gastrointestinal Medical Oncol	Yixing Jiang	UNITED STATES	Maryland	Baltimore
43	Multicare Regional Cancer Center - Tacoma - Multicare Regional Cancer Center -	Jennifer Slim	UNITED STATES	Washington	Tacoma
44	St Lukes Hospital Association of Duluth	Homam Alkaied	UNITED STATES	Minnesota	Duluth
45	University of Colorado Cancer Center	Sunnie Kim	UNITED STATES	Colorado	Aurora
46	Rhode Island Hospital - Lifespan Oncology Clinical Res	Howard Safran	UNITED STATES	Rhode Island	Providence
47	Dana-Farber Cancer Institute - Medicine	Peter Enzinger	UNITED STATES	Massachusetts	Boston
48	Massachusetts General Hospital Cancer Center - Hematology/Oncology	Peter Enzinger	UNITED STATES	Massachusetts	Boston
49	Beth Israel Deaconess Medical Center	Peter Enzinger	UNITED STATES	Massachusetts	Boston
50	Memorial Regional Hospital East	Jennifer Zikria	UNITED STATES	Florida	Hollywood
51	Memorial Hospital West	Jennifer Zikria	UNITED STATES	Florida	Hollywood
52	Orlando Health Inc.	Omar Kayaleh	UNITED STATES	Florida	Orlando
53	Gene Upshaw Memorial Tahoe Forest Cancer Center	Thomas Semrad	UNITED STATES	California	Truckee
54	St. Joseph Heritage Healthcare	David Park	UNITED STATES	California	Fullerton
55	Comprehensive Blood & Cancer Center	David Kanamori	UNITED STATES	California	Bakersfield
56	Mount Sinai West	Celina Ang	UNITED STATES	New York	New York
57	Regions Hospital	Daniel M Anderson	UNITED STATES	Minnesota	St. Louis Park
58	Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital - Oncology	David Ilson	UNITED STATES	New York	New York
59	Memorial Sloan Kettering Cancer Center (MSKCC) - Basking Ridgel - Oncology	David Ilson	UNITED STATES	New York	New York
60	Memorial Sloan-Kettering Cancer Center - Oncology - West Harrison	David Ilson	UNITED STATES	New York	New York
61	Memorial Sloan-Kettering Cancer Center - Commack	David Ilson	UNITED STATES	New York	New York
62	Memorial Sloan Kettering Cancer Center (MSKCC) - Monmouth - Oncology	David Ilson	UNITED STATES	New York	New York
63	Memorial Sloan Kettering Cancer Center - Oncology - Bergen	David Ilson	UNITED STATES	New York	New York
64	Memorial Sloan Kettering Cancer Center	David Ilson	UNITED STATES	New York	New York
65	St. Mary's Hospital Center	Richard Dalfen	CANADA	Quebec	Montreal
66	Alberta Health Services - Cross Cancer Institute - Endocrine/Gastrointestinal Can	Jennifer Spratlin	CANADA	Alberta	Edmonton
67	McGill University Health Center	Thierry Alcindor	CANADA	Quebec	Montreal
68	Atlantic Health Sciences Corporation - Oncology	Samantha Gray	CANADA	New Brunswick	Saint John
69	Mount Sinai Hospital	Christine Brezden-Masley	CANADA	Ontario	Toronto
70	Cliniques Universitaires Saint-Luc	Marc Van den Eynde	BELGIUM	Brussels Capital Region	Bruxelles
71	CHU de Liège - Domaine Universitaire du Sart Tilman	Joelle Collignon	BELGIUM	Liege	Liege
72	Institut Jules Bordet - Oncologie Médicale	Amelie Deleporte	BELGIUM	Brussels Capital Region	Brussels
73	AZ Sint-Lucas - Campus Sint-Lucas	Joris Arts	BELGIUM	West-Vlaanderen	Brugge (Assebroek)
74	UZ Leuven - Campus Gasthuisberg	Eric Van Cutsem	BELGIUM	Vlaams Brabant	Leuven
75	UZ Antwerpen - Oncologie	Marc Peeters	BELGIUM	Antwerpen	Edegem
76	CHU Ambroise Paré	Stephane Holbrechts	BELGIUM	Hainaut	Mons
77	Centre Hospitalier Jolimont	Thierry Delaunoit	BELGIUM	Hainaut	Haine-Saint-Paul
78	Grand H？pital de Charleroi - Site Notre-Dame	Isabelle Sinapi	BELGIUM	Hainaut	Charleroi
79	AZ Maria Middelares - Campus Maria Middelares	Erik Vanderstraeten	BELGIUM	Oost-Vlaanderen	Gent
80	Centre Eugene Marquis - medical oncology	Samuel LE SOURD	FRANCE	Ille-et-Vilaine	Rennes
81	Hopital Saint Antoine - Aphp H？pitaux Universitaires Est Par	Thierry Andre	FRANCE	Paris	Paris
82	Hopital Privé Jean Mermoz - Gastro-entérologie et Cancérologie Digestive	Pascal Artru	FRANCE	Rhone	Lyon
83	CHU De Nice - H？′pital De L'Archet - P？′le H？？patite C	Anne-Claire Frin	FRANCE	Alpes-Maritimes	Nice
84	Hospital of Poitiers - La vienne	David Tougeron	FRANCE	Vienne	Poitiers
85	Centre Antoine Lacassagne - Oncology	Ludovic Evesque	FRANCE	Alpes-Maritimes	nice
86	CHRU Jean Minjoz	Christophe Borg	FRANCE	Franche-Comté	Besancon cedex
87	Centre Georges-Francois Leclerc	Fran？ois Ghiringhelli	FRANCE	Bourgogne	Dijon
88	Hopital Morvan - CHRU de Brest - cancérologie et d'hématologie	Jean-Philippe Metges	FRANCE	Bretagne	Brest Cedex
89	ICM Val d'Aurelle - Oncologie Médicale	Emmanuelle Samalin	FRANCE	Languedoc-Roussillon	Montpellier Cedex 5
90	Institut de Cancérologie de l'Ouest	Julie Vanbockstael	FRANCE	Angers Cedex 02	Angers Cedex 02
91	Henri Mondor - Albert Chevenier - Service Oncologie Médicale	Christophe Tournigand	FRANCE	Val-de-Marne	Créteil
92	CHU Saint Etienne - Hepatologie, Gastroentérologie (HGE) et d'oncologie digestive	Jean-Marc Phelip	FRANCE	Rh？ne-Alpes	Saint Priest en Jarez
93	Centre Leon Berard - departement d'oncologie medicale	Christelle De la Fouchardiere	FRANCE	Rh？ne	Lyon cedex 08
94	H.U.V.Arrixaca	Miguel Marin Vera	SPAIN	Murcia	Murcia
95	Hospital Universitario Ramón y Cajal	Federico Longo Mu？oz	SPAIN	Madrid	Madrid
96	Hospital del Mar	Joana Vidal Barrull	SPAIN	Barcelona	Barcelona
97	Hospital Universitario Miguel Servet	Roberto Pazo	SPAIN	Zaragoza	Zaragoza
98	Hospital General Universitario Gregorio Mara？ón	Montserrat Blanco	SPAIN	Madrid	Madrid
99	Hospital Ntra. Sra. de Sonsoles	Elena Filipovich	SPAIN	Castilla y León	Avila
100	Hospital Universitario Fundación Alcorcón	Alicia Hurtado	SPAIN	Madrid	Alcorcón
101	Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol	Laura Layos	SPAIN	Barcelona	Barcelona
102	Hospital Universitario Vall d'Hebrón	Marc Diez Garcia	SPAIN	Barcelona	Barcelona
103	Hospital de La Santa Creu i Sant Pau	Marta Martin Richard	SPAIN	Barcelona	Barcelona
104	M.D. Anderson Center Madrid	Sara Encinas Garcia	SPAIN	Madrid	Madrid
105	Hospital Universitario Virgen de la Macarena	Juan Reina Zoilo	SPAIN	Sevilla	Sevilla
106	H.U. de Burgos	Ana Maria López Mu？oz	SPAIN	Burgos	Burgos
107	Ospedale Guglielmo da Saliceto, AUSL Piacenza	Luigi Cavanna	ITALY	Piacenza	Piacenza
108	ASST Papa Giovanni XXIII - Oncologia - Bergamo	Carlo Tondini	ITALY	Bergamo	Bergamo
109	IRCCS Ospedale S.Raffaele - Oncologia Medica	Michele Reni	ITALY	Milano	Milano
110	IEO, IRCCS	Nicola Fazio	ITALY	Milano	Milano
111	ASST di Cremona SC Oncologia medica - Medical Oncology	Rodolfo Passalacqua	ITALY	Cremona	Cremona
112	IRCCS IRST	Giovanni Luca Frassineti	ITALY	Forli	Meldola
113	AOU di Parma	Francesca Negri	ITALY	Parma	Parma
114	Ospedale Umberto I, AOU Ospedali Riuniti Umberto I – GM.Lanc - Oncologia Medica	Rossana Berardi	ITALY	Ancona	Ancona
115	Humanitas Gavazzeni	Giordano Beretta	ITALY	Bergamo	Bergamo
116	PU Campus Bio-medico di Roma	Giuseppe Tonini	ITALY	Roma	Roma
117	Istituto Oncologico Veneto IOV-IRCCS	Fotios Loupakis	ITALY	Padova	Padova
118	Ospedale S.Maria della Misericordia, AO di Perugia, Universi	Fausto Roila	ITALY	Perugia	Perugia
119	SO S.Chiara, AOU Pisana - Oncologia 2	Lorenzo Fornaro	ITALY	Pisa	Pisa
120	Ospedale San Gerardo-ASST Monza	Raffaella Longarini	ITALY	Milano	Monza
121	AOU Policlinico di Modena	Gabriele Luppi	ITALY	Modena	Modena
122	Arcispedale S. Maria Nuova, AO di Reggio Emilia	Francesco Iachetta	ITALY	Reggio Emilia	Reggio Emilia
123	Osp S.Bortolo, ULSS8 Berica	Giuseppe Aprile	ITALY	Veneto	Vicenza
124	AOU Città della Salute e della Scienza di Torino - Molinette	Libero Ciuffreda	ITALY	Torino	Torino
125	Azienda Ospedaliera S. Maria	Sergio Bracarda	ITALY	Terni	Terni
126	Edinburgh Cancer Centre Western General Hospital - Oncology	Lucy Wall	UNITED KINGDOM	Scotland	Edinburgh
127	Leeds Cancer Centre at St. James's University Hospital - Leeds Cancer Centre	Daniel Swinson	UNITED KINGDOM	York	Leeds
128	University Hospitals Coventry & Warwickshire - Oncology	Martin Scott-Brown	UNITED KINGDOM	Warwickshire	Coventry
129	The Royal Marsden Hospital (Surrey)	Ian Chau	UNITED KINGDOM	Sutton	Sutton
130	The Royal Marsden NHS Foundation Trust - Royal Marsden Hospi	Ian Chau	UNITED KINGDOM	Sutton	Sutton
131	Addenbrookes Hospital	Elizabeth Smyth	UNITED KINGDOM	Cambridgeshire	Cambridge
132	Christie Hospital NHS Foundation Trust	Tom Waddell	UNITED KINGDOM	Manchester	Manchester
133	Royal Free Hospital London NHS Trust	Roopinder Gillmore	UNITED KINGDOM	London	London
134	Aberdeen Royal Infirmary - Oncology	Ishtiaq Zubairi	UNITED KINGDOM	Aberdeenshire	Aberdeen
135	Sarah Cannon Research Institute	Hendrik-Tobias Arkenau	UNITED KINGDOM	London	London
136	University of Dundee - NHS Tayside - Ninewells Hospital & Me	Russell Petty	UNITED KINGDOM	Dundee	Dundee
137	Narodowy Instytut Onkologii im. Marii Sk？odowskiej-Curie – Państwowy Instytut Badawczy	Lucjan Wyrwicz	POLAND	Mazowieckie	Warszawa
138	Szpital Specjalist. w Brzozowie,Podkarpacki O？rodek Onkologi	Dariusz Sawka	POLAND	Podkarpackie	Brzozow
139	Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli	Bozena Kukielka - Budny	POLAND	Lubelskie	Lublin
140	Mazowiecki Szpital Onkologiczny	Malgorzata Chudzik	POLAND	Mazowieckie	Wieliszew
141	Centrum Medyczne Pratia Ostroleka	Agnieszka Domurad	POLAND	Mazowieckie	Ostroleka
142	Centrum Onkologii im. prof. F. Lukaszczyka	Adrianna Makarewicz	POLAND	Kujawsko-pomorskie	Bydgoszcz
143	Narodowy Instytut Onkologii im. Marii Sk？odowskiej-Curie – Państwowy Instytut Badawczy	Anna Cencelewicz - Lesikow	POLAND	Mazowieckie	Warszawa
144	Johannes Gutenberg-Universit？t	Markus Moehler	GERMANY	Rheinland-Pfalz	Mainz
145	Universit？tsklinikum Leipzig	Florian Lordick	GERMANY	Sachsen	Leipzig
146	Klinikum Bogenhausen	Martin Fuchs	GERMANY	Bayern	München
147	LMU - Klinikum der Universitaet Muenchen - Campus Grosshader	Volker Heinemann	GERMANY	Bayern	Muenchen
148	Universit？tsklinikum Carl Gustav Carus Dresden - Medizinische Klinik und Poliklinik I	Gunnar Folprecht	GERMANY	Sachsen	Dresden
149	Charité - Campus Virchow-Klinikum (CVK)	Peter Thuss-Patience	GERMANY	Berlin	Berlin
150	Helios Klinikum Berlin-Buch	Peter Reichardt	GERMANY	Berlin	Berlin-Buch
151	Praxis Kr？ning	Hendrik Kr？ning	GERMANY	Sachsen-Anhalt	Magdeburg
152	Charite - Campus Benjamin Franklin (Cbf)	Christoph Treese	GERMANY	Berlin	Berlin
153	St？dtisches Klinikum Dresden - Medizinische Klinik IV	Harald Schmalenberg	GERMANY	Sachsen	Dresden
154	SLK Kliniken Heilbronn GmbH - Onkologisches Studienzentrum	Uwe Martens	GERMANY	Baden-Württemberg	Heilbronn
155	Onkologisches Versorgungszentrum Friedrichshain	Fritz Albert Maiwirth	GERMANY	Berlin	Berlin
156	Studiengesellschaft BSF UG	Lars Fechner	GERMANY	Sachsen-Anhalt	Halle
157	Clínica Anglo Americana	Ashley Alarcon Rozas	PERU	Lima	Lima
158	Centro Médico Monte Carmelo	Renzo Alvarez Barreda	PERU	Arequipa	Arequipa
159	Instituto de Oncología y Radioteraapia. Clinica Ricardo Palm	Manuel Jesus Philco Salas	PERU	Lima	San Isidro
160	UNIDAD DE INVES DE LA CLíNICA INTERNACIONAL SEDE SAN BORJA	LUIS VERA VALDIVIA	PERU	Lima	Lima
161	Clinica Santa Beatriz - Clinic	Ashley Alarcon Rozas	PERU	Lima	Lima
162	Médicos Especialistas en Cáncer S.C.	Froylan López-Lopez	MEXICO	Aguascalientes	Aguascalientes
163	Hospital Angeles - Metropolitano	Gloria Martínez Martínez	MEXICO	Distrito Federal	Mexico
164	Consultorio dentro de la Torre Medica Dalinde - Oncología Médica	Ricardo Villalobos-Valencia	MEXICO	Distrito Federal	Mexico
165	Oaxaca Site Managment Organization OSMO	Carlos Hernandez Hernandez	MEXICO	Oaxaca	Oaxaca
166	Instituto Nacional de Cancerologia (INCAN)	German Calderillo Ruiz	MEXICO	Distrito Federal	Mexico
167	Mexico Centre for Clinical Research	Lizbett Garcia Montes	MEXICO	Distrito Federal	Mexico
168	Centro Potosino de Investigación Médica SC	Jorge David Pérez Rodriguez	MEXICO	San Luis Potosi	San Luis Potosi
169	Investigacion Biomedica para el Desarrollo de Farmacos S.A (iBiomed) - Oncology	Emilio Murillo Ramirez	MEXICO	Jalisco	Zapopan
170	Sociedad de Metabolismo y Corazón S.C.	Yair Rojas	MEXICO	Veracruz	Veracruz
171	Centro de Novos Tratamentos Itajai	Giuliano Borges	BRAZIL	Santa Catarina	Itajai
172	FM ABC/ CEPHO	Daniel Cubero	BRAZIL	S？o Paulo	Santo Andre
173	Hospital Santa Marcelina	Roberto Rocha	BRAZIL	S？o Paulo	S？o Paulo
174	Hospital de Base de S？o José do Rio Preto - CIP	Gustavo Girotto	BRAZIL	S？o Paulo	S？o José do Rio Preto
175	Hospital Bruno Born	Leandro Brust	BRAZIL	Rio Grande do Sul	Lajeado
176	Fundacao Pio XII Hospital De Cancer de Barretos	Florinda Santos	BRAZIL	S？o Paulo	Barretos
177	A.C.Camargo Cancer Center	Helano Freitas	BRAZIL	S？o Paulo	S？o Paulo
178	Hospital Sirio Libanés	Gustavo Fernandes	BRAZIL	Distrito Federal	Brasília
179	Instituto COI de pesquisa, educa？？o e gest？o	Fernando Vieira	BRAZIL	Rio de Janeiro	Rio de Janeiro
180	Hospital Sao Vicente de Paulo (HSVP) - Internal Medicine	Luis Alberto Schlittler	BRAZIL	Rio Grande do Sul	Passo Fundo
181	CENANTRON - Centro Avan？ado de Tratamento Oncologico - Pesquisa Clinica	André Marcio Murad	BRAZIL	Minas Gerais	Belo Horizonte
182	ANIMI - Unidade de Tratamento Oncológico	Maite Schurmann	BRAZIL	Santa Catarina	Lages
183	Fundacion Arturo Lopez Perez	Luis Matamala Rebolledo	CHILE	Región Metropolitana de Santia	Santiago
184	Clinica San Carlos de Apoquindo - Oncology	Marcelo Adán Garrido Salvo	CHILE	Región Metropolitana de Santia	Santiago
185	Clinical Research SpA - Oncolo	Cesar Daniel Aguero	CHILE	Valdivia	Valdivia
186	Clinica Santa Maria	Eva Garcia Teran	CHILE	Región Metropolitana de Santia	Providencia
187	Hospital Clinico Universidad De Chile	Monica Ahumada Olea	CHILE	Región Metropolitana de Santia	Santiago
188	Centro de Investigaciones Clínicas (CIC) de la Fundación Valle del Lili	ángela Zambrano Harvey	COLOMBIA	Valle del Cauca	Cali
189	Hospital General de Medellín-Luz Castro de Gutiérrez - E.S.E	Victor Ramos Gonzalez	COLOMBIA	Antioquia	Medellin
190	Centro Medico Imbanaco de Cali S.A.	Alvaro Guerrero Villota	COLOMBIA	Valle del Cauca	Cali
191	Hospital Pablo Tobón Uribe	Isabel Durango	COLOMBIA	Antioquia	Medellin
192	Oncomédica S.A.	Fernando Oviedo Martínez	COLOMBIA	Córdoba	Monteria
193	Instituto De Cancerologia (IDC) - Clinica Las Americas	Eduardo Gutiérrez	COLOMBIA	Antioquia	Medellín
194	Hospital Universitario San Ignacio	Kelman Ojeda Rodriguez	COLOMBIA	Cundinamarca	Bogotá
195	Townsville Hospital	Suresh Varma	AUSTRALIA	Queensland	Douglas
196	Monash Health	Andrew Strickland	AUSTRALIA	Victoria	Clayton
197	St George Hospital	Katrin Sjoquist	AUSTRALIA	New South Wales	Kogarah
198	The Queen Elizabeth Hospital	Timothy Price	AUSTRALIA	South Australia	Woodville South
199	John Flynn Private Hospital	Sumit Lumba	AUSTRALIA	Queensland	Tugun
200	Osaka University Hospital - Medical Oncology	Daisuke Sakai	JAPAN	Osaka	Osaka
201	Shikoku Cancer Center - Gastroenterology	Tomohiro Nishina	JAPAN	Ehime	Matsuyama
202	National Cancer Center Hospital East - Gastrointestinal Oncology	Kohei Shitara	JAPAN	Tiba	Kashiwa
203	Osaka International Cancer Institute - Medical Oncology	Naotoshi Sugimoto	JAPAN	Osaka	Osaka
204	Kyushu University Hospital - Hematology/Oncology - Hematology/Oncology	Eiji Oki	JAPAN	Fukuoka	Fukuoka
205	National Cancer Center Hospital - Gastrointestinal Oncology	Hirokazu Shoji	JAPAN	Tokyo	Tsukiji
206	Hokkaido University Hospital - Medical Oncology Center	Yoshito Komatsu	JAPAN	Hokkaido	Sapporo
207	The Cancer Institute Hospital of JFCR - Medical Oncology	Kensei Yamaguchi	JAPAN	Koto-ku	Koto-ku
208	Aichi Cancer Center Hospital - Clinical Oncology	Yukiya Narita	JAPAN	Aichi	Nagoya
209	Saitama Cancer Center - Gastroenterology	Hiroki Hara	JAPAN	Saitama	Kitaadachi-gun
210	Osaka General Medical Center - Gastrointestinal Surgery	Kazumasa Fujitani	JAPAN	Osaka	Osaka
211	Shizuoka Cancer Center - Gastrointestinal Oncology	Hirofumi Yasui	JAPAN	Shizuoka	Sunto-gun
212	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital - Chemotherapy	Yasushi Omuro	JAPAN	Tokyo	Tokyo
213	Kobe City Medical Center General Hospital - Medical Oncology	Hisateru Yasui	JAPAN	Hyogo	Kobe
214	Saitama Medical University International Medical Center - Medical Oncology	Tetsuya Hamaguchi	JAPAN	Saitama	Hidaka
215	Seoul National University Bundang Hospital	Keun-Wook	KOREA	Gyeonggido	Seongnam-si
216	Seoul National University Hospital - Department of Internal	Do-Youn	KOREA	Seoul Teugbyeolsi	Seoul
217	Samsung Medical Center - Hematology-Oncology	Won Ki	KOREA	Seoul Teugbyeolsi	Seoul
218	Asan Medical Center - Oncology	Yoon-Koo Kang	KOREA	Seoul Teugbyeolsi	Seoul
219	The Catholic University of Korea, Seoul St. Mary's Hospital	In-Ho Kim	KOREA	Seoul Teugbyeolsi	Seoul
220	Korea University Guro Hospital - Hematology-Oncology	Sang Cheul Oh	KOREA	Seoul Teugbyeolsi	Seoul
221	Gachon University Gil Medical Center - Medical Oncology	Sun Jin Sym	KOREA	Incheon Gwang'yeogsi	Incheon
222	The Catholic University of Korea, St. Vincent's Hospital - Oncology	Byoung Yong Shim	KOREA	Gyeonggido	Suwon-si
223	Taipei Veterans General Hospital	Yee Chao	中国台湾	Taipei	Taipei
224	China Medical University Healthcare System	Li-Yuan Bai	中国台湾	Taichung Municipality	Taichung
225	Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology	Yen-Hao Chen	中国台湾	Kaohsiung	Kaohsiung
226	Chang Gung Medical Foundation (CGMF) - Linkou Branch	Jen-Shi Chen	中国台湾	Taoyuan	Kwei-Shan
227	National Taiwan University Hospital	Kun-Huei Yeh	中国台湾	Taipei	Taipei
228	National Cheng Kung University Hospital	Li-Tzong TainanChen	中国台湾	Tainan	Tainan
229	Rambam Health Care Campus	Irit Ben-Aharon	ISRAEL	Haifa	Haifa
230	Shaare Zedek Medical center	Esther Tahover	ISRAEL	Yerushalayim	Jerusalem
231	Tel Aviv Sourasky Medical Center - Oncology	Sharon Pelles Avraham	ISRAEL	Tel-Aviv	Tel Aviv
232	Meir Medical Center	Moshe Mishaeli	ISRAEL	HaMerkaz	Kfar Saba
233	Rabin Medical Center, Beilinson Hospital	Gali Perl	ISRAEL	Petah Tikva	Petah Tikva
234	The E. Wolfson Medical Center - Oncology	Ronen Brenner	ISRAEL	HaMerkaz	Holon
235	Assaf Harofeh Medical Center	Nirit Yarom	ISRAEL	HaMerkaz	Zerifin

1	在任何与研究有关的程序开始之前，必须从受试者或合法授权的代表（如适用）获得机构审查委员会（IRB）/独立伦理委员会（IEC）根据国家法规（例如，美国中心的健康保险流通与责任法案[HIPAA]授权）批准的书面知情同意书和隐私保护语言。
2	签署知情同意书时，受试者根据当地法规被视为成人（例如在美国，年龄为≥ 18岁）。
3	受试者同意在研究治疗期间不参加另一项干预性研究。
4	女性受试者如果未怀孕（筛选时血清妊娠试验阴性；血清β-人绒毛膜促性腺激素[βhCG]升高，但通过其他检测证实未怀孕的女性受试者有资格入组）且至少符合下列条件之一，则有资格参加研究： a.不是附录12.3 避孕要求中定义的有生育能力的女性（WOCBP）或者 b.是WOCBP，但同意在整个治疗期间以及研究药物末次给药后6个月内遵守附录12.3 避孕要求中定义的避孕指导。
5	女性受试者必须同意从筛选开始时和整个研究期间以及最终研究治疗给药后6个月内不进行哺乳。
6	女性受试者不得从筛选开始时和整个研究期间及最终研究药物给药后6个月内捐赠卵细胞。
7	具有育龄女性伴侣的性活跃男性受试者，必须同意在整个治疗期间以及研究药物末次给药后至少6个月使用附录12.3 避孕要求中所述避孕措施。
8	男性受试者不得从筛选开始时和整个研究期间以及最终研究药物给药后6个月内捐献精子。
9	具有妊娠或哺乳伴侣的男性受试者必须同意在整个研究期的妊娠期间或伴侣哺乳期间以及最终研究药物给药后6个月内禁欲或使用避孕套。
10	受试者经组织学证实诊断为胃癌或GEJ腺癌。
11	受试者在随机化前28天内经影像学证实为局部晚期不可切除或转移性疾病。
12	受试者在随机化前≤28天内根据RECIST 1.1，基于地方实验室评估有影像学可评估的疾病（可测量的和/或不可测量的）。对于只有1个可评价病灶和在随机化前≤3个月接受既往放疗的受试者，病灶必须在既往放疗范围外，或在放疗后有记录的进展。
13	受试者的肿瘤在≥ 75 %的肿瘤细胞中表达CLDN18.2，通过中心IHC检测证实为中等至强的膜染色。
14	受试者存在已知HER2阴性的胃或GEJ肿瘤。
15	受试者的ECOG体能状态为0到1。
16	研究者认为受试者的预期寿命≥ 12周。
17	在随机化之前14天内，根据收集的中心或地方实验室的检查分析，受试者必须符合以下所有标准。如果在此期间有多个中心实验室数据，则应使用最新数据确定合格性。 a.血红蛋白（Hgb）≥ 9 g/dL。如果输血后的Hgb≥ 9 g/dL，需要输血的受试者有入组资格。 b.绝对嗜中性粒细胞计数≥ 1.5 x 109/L c.血小板≥ 100 x 109/L d.白蛋白≥ 2.5 g/dL e.总胆红素≤正常上限（ULN）的1.5倍，并且无肝转移（若发生肝转移，则为＜3.0 ×ULN）f.天冬氨酸氨基转移酶和丙氨酸氨基转移酶≤ 2.5 x ULN，并且无肝转移（或者如果出现肝转移，≤ 5 x ULN） g.估计的肌酐清除率≥30 mL/min 凝血酶原时间/国际标准化比值和部分凝血活酶时间≤ 1.5 x ULN（除接受抗凝治疗的受试者外）

1	受试者已接受了既往全身性化疗治疗局部晚期不可切除或转移性胃或GEJ腺癌。但是只要受试者在随机化前至少6个月已完成新辅助化疗或辅助化疗的则可以接受。受试者在随机化前>28天已接受已知的具有抗肿瘤活性的中药治疗。
2	受试者在随机化之前≥14天接受过局部晚期不可切除或转移性胃癌或GEJ腺癌的放疗治疗，且尚未从任何相关毒性中恢复。
3	受试者在随机化前14天内已接受了全身性免疫抑制疗法，包括全身性皮质类固醇治疗。允许受试者使用生理替代剂量的氢化可的松或其等价物（定义为氢化可的松每日最高30mg或强的松每日最高10mg），接受单次全身性皮质类固醇治疗，或者接受全身性皮质类固醇治疗作为影像学成像造影剂用药的预防性用药。
4	受试者在随机化前28天内已接受了其他研究药物或器械。
5	受试者有既往严重过敏反应或对Zolbetuximab的已知组分或其他单克隆抗体（包括人源化或嵌合抗体）不耐受。
6	受试者已知对研究药物的任何组分有速发或迟发的超敏反应、不耐受或禁忌。
7	受试者对mFOLFOX6的任何组分既往有严重过敏反应或不耐受。
8	受试者已知有二氢嘧啶脱氢酶缺乏症（DPD）。（注意：应根据当地要求进行DPD缺乏症筛查。）
9	受试者患有完全胃出口综合征或部分胃出口综合征伴持续/反复呕吐。
10	根据研究者的判断，对于出现严重胃出血的受试者和/或未经治疗的胃溃疡的受试者，将排除受试者的参与。
11	受试者有己知的人类免疫缺陷病毒（HIV）感染或己知的活动性乙型肝炎（HBsAg阳性）或丙型肝炎感染的阳性检测史。注意：应根据当地要求进行这些感染的筛查。a.对于HBsAg阴性但HBcAb阳性的受试者，将进行HBVDNA检测，如果呈阳性则排除受试者。b.丙型肝炎病毒（HCV）血清学阳性但HCVRNA检测阴性的受试者具有入组资格。c.接受了HCV治疗且存在无法检测到病毒载量结果的受试者具有入组资格。
12	受试者在随机化之前的过去3个月内患有需要全身性治疗的活动性自身免疫性疾病
13	受试者患有需要全身性治疗的活跃性感染且在随机化前7天内未完全缓解。
14	受试者患有重大心血管疾病，包括以下任何情况： a.在随机化前6个月内的充血性心力衰竭（定义为纽约心脏协会III或IV级）、心肌梗塞、不稳定型心绞痛、冠状动脉血管成形术、支架置入术、冠状动脉搭桥术、脑血管意外或高血压危象 b.有临床意义的室性心律失常病史（如持续性室性心动过速，心室纤维性颤动或尖端扭转型室速） c.男性受试者QTc间期> 450毫秒；女性受试者QTc间期>470毫秒 d.先天性长QT综合征病史或家族史 e.需要抗心律失常药物治疗的心律失常（在随机化前，心房颤动率可控> 1个月的受试者有入组资格）受试者患有已知的活跃性中枢神经系统转移和/或癌性脑膜炎。
15	受试者中枢神经系统转移和/或癌性脑膜炎（源自胃/GEJ癌）病史。
16	受试者患有已知> 1级的外周感觉神经异常，除非深腱反射缺失是唯一的神经异常。
17	受试者在随机化前≤28天已接受了重大手术。 a．随机化前≤14天仍未从重大手术中完全康复的受试者应排除在外。
18	根据研究者的判断，受试者患有会妨碍研究依从性的精神疾病或社交情况。
19	受试者患有另一种恶性肿瘤，根据研究者的临床判断需要治疗。
20	受试者患有干扰受试者参与研究能力的任何并发疾病、感染或共患病症，使研究者认为受试者处于不适当的风险中或使数据解释更加复杂。

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