杭州DS-8201a100mg注射液III期临床试验-比较 T-DXd与 SoC化疗作为子宫内膜癌辅助治疗的试验

登记号	CTR20253443	试验状态	进行中
申请人联系人	施祎凡	首次公示信息日期	2025-08-26
申请人名称	Daiichi Sankyo, Inc./ 第一三共（中国）投资有限公司/ Baxter Oncology GmbH

登记号	CTR20253443
相关登记号	暂无
药物名称	DS-8201a 100mg注射液
药物类型	生物制品
临床申请受理号	企业选择不公示
适应症	子宫内膜癌
试验专业题目	一项德曲妥珠单抗对比标准化疗作为辅助治疗（联合或不联合放疗）治疗 HER2表达（IHC 3+/2+）的子宫内膜癌的 III期、多中心、随机、开放性试验
试验通俗题目	比较 T-DXd与 SoC化疗作为子宫内膜癌辅助治疗的试验
试验方案编号	DS8201-854	方案最新版本号	1.0
版本日期:	2025-02-28	方案是否为联合用药	否

申请人名称	[["Daiichi Sankyo, Inc."],["第一三共（中国）投资有限公司"],["Baxter Oncology GmbH"]]
联系人姓名	施祎凡	联系人座机	021-60397733	联系人手机号
联系人Email	shi.yifan.vx@daiichisankyo.com.cn	联系人邮政地址	上海市-上海市-南京西路1717号会德丰国际广场36楼	联系人邮编	200040

本试验旨在评价T-DXd 对比SoC 化疗作为辅助治疗（联合或不联合放疗）治疗HER2 表达（IHC 3+/2+）子宫内膜癌参与者的有效性和安全性。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	开放	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 无上限 (最大年龄)
性别	女
健康受试者	无
入选标准	[["签署ICF 时年龄≥18 岁的成人（如果参与试验的法定知情同意年龄>18 岁，请遵循当地法规要求）"],["经组织学确诊为子宫内膜上皮癌。除肉瘤外，允许其他所有组织学类型（允许癌肉瘤）。"],["新诊断为FIGO 2023 IIC 期（包括IICmp53abn 期）或III 期。注：FIGO 2023 IIC 期包括累及任何子宫肌层的侵袭性组织学类型疾病。FIGO 2023 III 期包括任何组织学亚型肿瘤局部和/或区域性扩散疾病。"],["根据2016 年ASCO-CAP 胃癌IHC 评分指南，经中心实验室检测确认存在HER2 表达（IHC 3+/2+）。"],["有足够的存档肿瘤组织样本（强烈建议使用手术获得的样本）可供中心实验室评估HER2 状态。"]]
排除标准	[["患有子宫间充质肿瘤，如子宫内膜间质肉瘤、平滑肌肉瘤或其他类型的纯肉瘤。腺肉瘤也不允许参与。"],["患有复发性或FIGO 2023 IV 期癌。"],["经BICR 评估确定手术后存在可测量的残留肿瘤。"],["通过获批和/或经验证的当地检测确定已知携带POLE 突变（根据当地法规[如适用]）"],["存在心肌梗死（随机化/入组前6 个月内）、症状性慢性心力衰竭（NYHA II 至IV级）病史。筛选时肌钙蛋白水平高于ULN（由生产商定义）且无任何心肌梗死相关症状的参与者，应在筛选期间进行心脏科会诊以排除心肌梗死。"],["根据筛选时三次重复12 导联ECG 的平均值，QTcF 延长至>480 ms。因并发肺部疾病导致的临床重度肺损伤，包括但不限于任何基础肺疾病（即试验入组前3 个月内发生的肺栓塞、重度哮喘、重度COPD、限制性肺疾病、胸腔积液等）和任何自身免疫性、结缔组织或炎症性疾病潜在累及肺部（即类风湿关节炎、舍格林综合征、结节病等）或既往全肺切除术。"],["7. 有需要皮质类固醇治疗的（非感染性）ILD/非感染性肺炎病史，目前患有ILD/非感染性肺炎，或筛选时存在无法通过影像检查排除的疑似ILD/非感染性肺炎。"]]

试验药

[["中文通用名:DS-8201a100mg注射液 英文通用名:DS-8201aforInjection100mg 商品名称:优赫得","剂型:冻干粉剂 规格:100mg 用法用量:静脉输注5.4mg/kg 用药时程:Q3W"]] 序号 名称 用法

对照药

[["中文通用名:卡铂 英文通用名:Carboplatininjection 商品名称:NA","剂型:输注用浓溶液 规格:10mg/ml150mg/15ml 用法用量:静脉输注AUC5或6 用药时程:Q3W"],["中文通用名:卡铂 英文通用名:Carboplatininjection 商品名称:NA","剂型:输注用浓溶液 规格:10mg/ml600mg/60ml 用法用量:静脉输注AUC5或6 用药时程:Q3W"],["中文通用名:顺铂注射液 英文通用名:CisplatinInjection 商品名称:NA","剂型:注射液 规格:50ml:50mg 用法用量:静脉输注50mg/m2 用药时程:第一天和第29天"],["中文通用名:多西他赛注射液 英文通用名:Docetaxel 商品名称:NA","剂型:注射液 规格:80mg/4mL 用法用量:静脉输注75mg/m2 用药时程:Q3W"],["中文通用名:紫杉醇注射液 英文通用名:Paclitaxel 商品名称:NA","剂型:注射液 规格:16.7ml:100mg 用法用量:175mg/m2静脉输注 用药时程:Q3W"]] 序号 名称 用法

主要终点指标及评价时间	[["通过BICR 或组织病理学确认疾病复发(根据当地评估)所评估的无疾病生存期","从随机化至首次记录到局部区域性复发、远处转移或全因死亡（以先发生者为准），最长约51个月","有效性指标"]] 序号 指标 评价时间 终点指标选择
次要终点指标及评价时间	[["总生存期","从随机化日期至全因死亡日期，最长约63个月","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	朱笕青	学位	医学博士	职称	主任医师
	电话	13605818467	Email	zjq-hz@126.com	邮政地址	浙江省-杭州市-拱墅区半山东路1号
	邮编	310022	单位名称	浙江省肿瘤医院

[["浙江省肿瘤医院","朱笕青","中国","浙江省","杭州市"],["天津市肿瘤医院","王珂","中国","天津市","天津市"],["海南省人民医院","朱根海","中国","海南省","海口市"],["福建省肿瘤医院","林安","中国","福建省","福州市"],["宜宾市第二人民医院","汪善兵","中国","四川省","宜宾市"],["中南大学湘雅医院","张瑜","中国","湖南省","长沙市"],["温州医科大学附属第一医院","颜笑健","中国","浙江省","温州市"],["四川大学华西第二医院","尹如铁","中国","四川省","成都市"],["广西医科大学附属肿瘤医院","姚德生","中国","广西壮族自治区","南宁市"],["河南省肿瘤医院","王莉","中国","河南省","郑州市"],["西安交通大学第一附属医院","安瑞芳","中国","陕西省","西安市"],["北京肿瘤医院","郑虹","中国","北京市","北京市"],["华中科技大学同济医学院附属同济医院","陈刚","中国","湖北省","武汉市"],["华中科技大学同济医学院附属协和医院","李贵玲","中国","湖北省","武汉市"],["山东省肿瘤医院","李大鹏","中国","山东省","济南市"],["吉林大学第一医院","魏振彤","中国","吉林省","长春市"],["中国医科大学附属盛京医院","高嵩","中国","辽宁省","沈阳市"],["临沂市肿瘤医院","李秀敏","中国","山东省","临沂市"],["烟台毓璜顶医院","杨瑛","中国","山东省","烟台市"],["云南省肿瘤医院","杨宏英","中国","云南省","昆明市"],["江西省妇幼保健院","何林生","中国","江西省","南昌市"],["郑州大学第二附属医院","赵虎","中国","河南省","郑州市"],["安徽省立医院","周颖","中国","安徽省","合肥市"],["浙江大学医学院附属妇科医院（浙江省妇女保健院）","吕卫国","中国","浙江省","杭州市"],["复旦大学附属妇产科医院","王超","中国","上海市","上海市"],["上海市第一妇婴保健院","万小平","中国","上海市","上海市"],["上海市第十人民医院","陈晓军","中国","上海市","上海市"],["辽宁省肿瘤医院","王丹波","中国","辽宁省","沈阳市"],["Sunnybrook Health Sciences Centre","Gien Lilian","Canada","Ontario","Toronto"],["McGill University Health Centre/Glen Site / Royal Victoria Hospital","Gilbert Lucy","Canada","Quebec","Montreal"],["CHUM","Samouelian Vanessa","Canada","Quebec","Montreal"],["Cross Cancer Institute","Sabourin Jeannelle","Canada","Alberta","Edmonton"],["Health Sciences Centre Winnipeg","Altman Alon","Canada","Manitoba","Winnipeg"],["Avera Medical Group Gynecologic Oncology Sioux Falls","Starks David","United States","South Dakota","Sioux Falls"],["Texas Oncology, P.A. - Tyler","Priebe Anna","United States","South Dakota","Sioux Falls"],["Willamette Valley Clinical Studies","Anderson Charles","United States","Oregon","Eugene"],["Icahn School of Medicine at Mount Sinai PRIME","Blank Stephanie","United States","New York","New York"],["Laura and Isaac Perlmutter Cancer Center at NYU Langone Health","Pothuri Bhavana","United States","New York","New York"],["UC San Diego Moores Cancer Center","Eskander Ramez","United States","California","La Jolla"],["The University of Chicago Medical Center","Kurnit Katherine","United States","Illinois","Chicago"],["Optimum Clinical Research Group","Finkelstein Karen","United States","New Mexico","Albuquerque"],["Texas Oncology San Antonio Medical Center","Santillan-Gomez Antonio","United States","Texas","San Antonio"],["Brown University - Women and Infant's Hospital","Oliver Matthew","United States","Rhode Island","Providence"],["Trials365 LLC","Black Destin","United States","Louisiana","Shreveport"],["Northwest Cancer Specialists, P.C","Wysham Weiya","United States","Oregon","Tigard"],["Minnesota Oncology Hematology, P.A.","Mallen Adrianne","United States","Minnesota","Coon Rapids"],["Ohio State University","Backes Floor","United States","Ohio","Columbus"],["HonorHealth Research Institute","Willmott Lyndsay","United States","Arizona","Scottsdale"],["Texas Oncology - Bedford","Messing Mark","United States","Texas","Bedford"],["Mount Sinai Medical Center","Slomovitz Brian","United States","Florida","Miami Beach"],["Miami Cancer Institute","Diaz John","United States","Florida","Miami"],["Parkview Research Center","Menzies Anya","United States","Indiana","Fort Wayne"],["Novant Health Huntersville Medical Center","Fauci Janelle","United States","North Carolina","Charlotte"],["Intermountain Health West End Clinic","Petersen Megan","United States","Montana","Billings"],["Western Pennsylvania Hospital","Crafton Sarah","United States","Pennsylvania","Pittsburgh"],["Florida Cancer Specialists East","Monk Bradley","United States","Florida","West Palm Beach"],["Sanford Research / USD-Sioux Falls","Bell Maria","United States","South Dakota","Sioux Falls"],["The Center of Hope Reno","Lim Peter","United States","Nevada","Reno"],["University of Colorado","Corr Bradley","United States","Colorado","Aurora"],["Tufts","Gonzalez Rafael","United States","Massachusetts","Boston"],["Broward Health Medical Center","Jordan Scott","United States","Florida","Ft. Lauderdale"],["FirstHealth of the Carolinas, Inc.","Sundborg Michael","United States","North Carolina","Pinehurst"],["University of Cincinnati Physicians Group, LLC","Jackson Amanda","United States","Ohio","Cincinnati"],["Aretaieio Hospital","Zagouri Flora","Greece","NA","Athens"],["Hospital Mitera","Syrios Ioannis","Greece","NA","Athens"],["St Luke's Hospital","Fountzila Elena","Greece","NA","Thessaloniki"],["University General Hospital Attikon","Koumarianou Anna","Greece","NA","Athens"],["IASO General Clinic","Papadimitriou Christos","Greece","NA","Marousi"],["General Hospital of Athens","Liontos Michail","Greece","NA","Athens"],["Centre Francois Baclesse","Joly Florence","France","Calvados","Caen Cedex 05"],["Institut Bergonié","Lebreton Coriolan","France","Gironde","Bordeaux cedex"],["CHU Besancon - Hopital Jean Minjoz","Mansi Laura","France","Doubs","Besancon Cedex"],["CHU de Brest - Hopital de la Cavale Blanche","Deiana Laura","France","Finistere","Brest"],["Institut de Cancérologie de Strasbourg Europe - ICANS","Eberst Lauriane","France","Bas Rhin","Strasbourg"],["Institut Sainte Catherine","Billemont Bertrant","France","Vaculuse","Avignon Cedex 9"],["Centre Antoine Lacassagne","Follana Philippe","France","Alpes Maritimes","Nice"],["CRLCC Eugene Marquis","De La Motte Rouge Thibault","France","Ille et Vilaine","Rennes cedex"],["Institut Claudius Regaud","Gladieff Laurence","France","Haute Garonne","Toulouse"],["Centre Jean Perrin - CLCC","Kalbacher Elsa","France","Puy de Dome","Clermont Ferrand cedex 01"],["Hopital Privé du Confluent","Blonz Cyriac","France","Loire Atlantique","Nantes cedex 2"],["Centre de Cancérologie du Grand Montpellier","Guardiola Emmanuel","France","Herault","Montpellier"],["Centre Oscar Lambret","Abdeddaim Cyril","France","Nord","Lille cedex"],["Institut Gustave Roussy","Leary Alexandra","France","Val de Marne","Villejuif cedex"],["Centre Hospitalier Lyon Sud","Peron Julien","France","Rhone","Pierre Benite cedex"],["ICO Girona - Hospital Universitari de Girona Dr Josep Trueta","Barretina Ginesta Pilar","Spain","Girona","Girona"],["Hospital Universitario 12 de Octubre","Manso Sanchez Luis Manuel","Spain","Madrid","Madrid"],["Hospital Universitario La Paz","Redondo Sanchez Andres","Spain","Madrid","Madrid"],["Hospital Clinic de Barcelona","Gaba Garcia Lydia","Spain","Barcelona","Barcelona"],["Instituto Valenciano de Oncologia IVO","Romero Noguera Ignacio","Spain","Valencia","Valencia"],["Complejo Hospitalario Universitario A Coruna","Quindos Varela Maria","Spain","La Coruna","La Coruna"],["Hospital Universitario Virgen Macarena","Gordon Santiago Maria Del Mar","Spain","Sevilla","Sevilla"],["Hospital Universitario Virgen de la Arrixaca","Puertes Boix Ana","Spain","Murcia","El Palmar"],["ICO Badalona - Hospital Universitari Germans Trias i Pujol","Guillen Sentis Pau","Spain","Barcelona","Badalona"],["Hospital Universitari Son Espases","Justo de la Pena Marina","Spain","Baleares","Palma de Mallorca"],["Hospital Universitario Ramon y Cajal","Cortes Salgado Alfonso","Spain","Madrid","Madrid"],["Hospital Universitari Vall d'Hebron - VHIO","Garcia Illescas David","Spain","Barcelona","Barcelona"],["Instituto Português de Oncologia do Porto Francisco Gentil, EPE","Abreu Miguel","Portugal","NA","Porto"],["Centro Hospitalar e Universitário de Coimbra E.P.E.","M C Rodrigues Joana","Portugal","NA","Coimbra"],["Hospital da Luz","Nave Mónica","Portugal","NA","Lisboa"],["Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.","Marques Cristiana","Portugal","NA","Vila Nova de Gaia"],["IEO Istituto Europeo di Oncologia","Colombo Nicoletta","Italy","Milano","Milano"],["Ospedale San Raffaele","Mangili Giorgia","Italy","Milano","Milano"],["Humanitas San Pio X","Lorusso Domenica","Italy","Milano","Milano"],["IOV - Istituto Oncologico Veneto IRCCS","Guarneri Valentina","Italy","Padova","Padova"],["Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS","Zamagni Claudio","Italy","Bologna","Bologna"],["Fondazione IRCCS Istituto Nazionale dei Tumori","Raspagliesi Francesco","Italy","Milano","Milano"],["Ospedale Mauriziano Umberto I","Ferrero Annamaria","Italy","Torino","Torino"],["Istituto Nazionale Tumori Fondazione G. Pascale","Pisano Carmela","Italy","Napoli","Napoli"],["Fondazione IRCCS San Gerardo dei Tintori","Canova Stefania","Italy","Milano","Monza"],["Azienda Ospedaliera Universitaria Careggi","Petrella Maria Cristina","Italy","Firenze","Firenze"],["Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Fagotti Anna","Italy","Roma","Roma"],["Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)","Tognon Germana","Italy","Brescia","Brescia"],["Azienda Ospedaliera Universitaria- Università degli Studi della Campania “Luigi Vanvitelli”","Bianco Roberto","Italy","Napoli","Napoli"],["Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia","Bologna Alessandra","Italy","Reggio Emilia","Reggio Emilia"],["Presidio Ospedaliero Alessandro Manzoni di Lecco","Crippa Alessandra","Italy","Lecco","Lecco"],["Nuovo Ospedale degli Infermi","Zavallone Laura","Bari","Biella","Pinderano"],["Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari","Naglieri Emanuele","Bari","Bari","Bari"],["Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawla II w Siedlcach Sp z o o","Bodnar Lubomir","Poland","NA","Siedlce"],["Szpitale Pomorskie spólka z ograniczona odpowiedzialnoscia","Pikiel Joanna","Poland","NA","Gdynia"],["Uniwersytecki Szpital Kliniczny w Poznaniu","Madry Radoslaw","Poland","NA","Poznan"],["Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie","Mackowiak Matejczyk Beata","Poland","NA","Bialystok"],["Uniwersyteckie Centrum Kliniczne","Klasa Mazurkiewicz Dagmara","Poland","NA","Gdansk"],["Uniwersytecki Szpital Kliniczny w Bialymstoku","Knapp Pawel","Poland","NA","Bialystok"],["Universitaetsklinikum Duesseldorf AoeR","Fehm Tanja","Germany","Nordrhein Westfalen","Duesseldorf"],["Universitaetsklinikum Ulm","Heublein Sabine","Germany","Baden Wuerttemberg","Ulm"],["Universitaetsklinikum Frankfurt Goethe-Universitaet","Rost Maximilian","Germany","Hessen","Frankfurt"],["Universitaetsklinikum Freiburg","Rautenberg Beate","Germany","Baden Wuerttemberg","Freiburg"],["Klinikum Lippe-Detmold","Ataseven Beyhan","Germany","Nordrhein Westfalen","Detmold"],["Universitaetsklinikum Carl Gustav Carus TU Dresden","Wimberger Pauline","Germany","Sachsen","Dresden"],["Kliniken Essen-Mitte","Welz Julia","Germany","Nordrhein Westfalen","Essen"],["Universitaetsklinikum Hamburg-Eppendorf","Schmalfeldt Barbara","Germany","Hamburg","Hamburg"],["Instituto de Oncologia de Rosario","Micheri Cristian","Argentina","Santa Fe","Rosario"],["Organizacion Medica de Investigacion (OMI)","Alfie Margarita Sonia","Argentina","Buenos Aires","CABA"],["Centro de Investigaciones Medicas Mar del Plata","Barbero Arturo","Argentina","Buenos Aires","Mar del Plata"],["Hospital Aleman","Gomez Abuin Gonzalo","Argentina","Ciudad Autonoma Buenos Aires","Buenos Aires"],["Instituto Medico de la Fundacion Estudios Clinicos","Romitelli Betiana","Argentina","Santa Fe","Rosario"],["Sanatorio Allende Cerro","Cortes Matias","Argentina","Cordoba","Cordoba"],["Sanatorio Privado de la Canada - Cordoba","Fogtman Ruben","Argentina","Cordoba","Cordoba"],["Hospital Italiano de Buenos Aires","Riggi Maria Cecilia","Argentina","Buenos Aires","Ciudad Autonoma Buenos Aires"],["Hospital Provincial del Centenario","Pastor Andrea","Argentina","Santa Fe","Rosario"],["CEMAIC - Centro Medico Privado","Salinas Jorge Emilio","Argentina","Cordoba","Cordoba"],["Instituto Medico Especializado Alexander Fleming","Giornelli Gonzalo","Argentina","Ciudad Autonoma Buenos Aires","Buenos Aires"],["Hospital Britanico de Buenos Aires","Vera Karina","Argentina","Ciudad Autonoma Buenos Aires","Ciudad Autonoma Buenos Aires"],["CER San Juan Centro Polivalente de Asistencia e Inv. Clinica","Valdez Jorge","Argentina","San Juan","San Juan"],["Hospital de Cancer de Barretos - Fundacao Pio XII","Paiva Carlos Eduardo","Brazil","Sao Paulo","Barretos"],["Fundacao Doutor Amaral Carvalho","Ranzani Brigida","Brazil","Sao Paulo","Jaú"],["INCA - Instituto Nacional de Cancer","de Melo Andreia Cristina","Brazil","Rio do Janeiro","Rio de Janeiro"],["Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto","Cardoso Guedes Joao Daniel","Brazil","Sao Paulo","Sao Jose Rio Preto"],["Instituto de Cancer de Londrina","Miyasaki Piovesana Mariana","Brazil","Paraná","Londrina"],["CEMEC CTO","Melo Fernandes Bruno","Brazil","Pará","Belem"],["Hospital Haroldo Juacaba - Instituto do Cancer do Ceará","Fernandes Monteiro Maria Marcela","Brazil","Ceará","Fortaleza"],["Centro de Pesquisa Clinica Onconeo","Anjos Sampaio Cristina","Brazil","Mato Grosso","Campo Grande"],["Centro de Pesquisas Oncology Natal","de Almeida Matias Danielli","Brazil","Rio Grande do Norte","Natal"],["Hospital Ernesto Dornelles","Santiago Escovar Carlos Eugenio","Brazil","Rio Grande do Sul","Porto Alegre"],["Irmandade da Santa Casa de Misericórdia de Porto Alegre","Arima Tiscoski Katsuki","Brazil","Rio Grande do Sul","Porto Alegre"],["Caism Hospital Da Mulher J A Pinotti","Ramalho Susana","Brazil","Sao Paulo","Campinas"],["Centro de Pesquisas do Servico de Ginecologia e Mama do Hospital Araujo Jorge","De Freitas Junior Ruffo","Brazil","Goiás","Goiania"],["ICESP - Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira","Severino da Silva Samantha Cabral","Brazil","Sao Paulo","Sao Paulo"],["ICAVC - Instituto do Cancer Arnaldo Vieira de Carvalho","Marubayashi Patricia","Brazil","Sao Paulo","Sao Paulo"],["Hospital Santa Marcelina","Odebrecht Rocha Roberto","Brazil","Sao Paulo","Sao Paulo"],["Obras Sociais Irma Dulce - Hospital Santo Antonio","Andrade Livia Maria","Brazil","Bahia","Salvador"],["Hospital de Amor da Amazonia","Gurgel Camara Jessica Priscilla","Brazil","Rondonia","Porto Velho"],["Oncocentro - Oncoclinicas do Brasil Servicos Médicos","Nogueira Rodrigues Angelica","Brazil","Minas Gerais","Belo Horizonte"],["Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer","Soares Nunes Joao","Brazil","Paraná","Curitiba"],["IMIP - Instituto de Medicina Integral Professor Fernando Figueira","do Prado Moura Jose Fernando","Brazil","Pernambuco","Recife"],["Centro de Investigaciones Clinicas de la Universidad Catolica","Ibanez Caceres Carolina","Chile","NA","Santiago"],["Biocenter","Rodriguez De Vasquez Esther Mireya","Chile","NA","Concepcion"],["Centro de Estudios Clinicos SAGA","Garrido Salvo Marcelo Adan","Chile","NA","Santiago"],["Centro de Investigacion Clinica Bradford Hill","Gallardo Araneda Carlos","Chile","NA","Santiago"],["Centro de Investigacion del Maule","Leiva Madariaga Juan Enrique","Chile","NA","Talca"],["King Chulalongkorn Memorial Hospital","Manchana Tarinee","Thailand","Bangkok","Pathum Wan"],["Siriraj Hospital","Jaishuen Atthapon","Thailand","Bangkok","Bangkok"],["Maharaj Nakorn Chiang Mai Hospital","Cheewakriangkrai Chalong","Thailand","Chiang Mai","Chiangmai"],["Ramathibodi Hospital","Lertkhachonsuk Arb aroon","Thailand","Bangkok","Bangkok"],["Songklanagarind Hospital","Jiamset Ingporn","Thailand","Songkhla","Hat Yai"],["Saitama Medical University International Medical Center","Hasegawa Kosei","Japan","Saitama-Ken","Hidaka-shi"],["Hyogo Cancer Center","Yamamoto Kasumi","Japan","Hyogo-Ken","Akashi-shi"],["Okayama University Hospital","Nagao Shoji","Japan","Okayama-Ken","Okayama-shi"],["National Cancer Center Hospital","Yonemori Kan","Japan","Tokyo-To","Chuo-ku"],["Cancer Institute Hospital of JFCR","Yunokawa Mayu","Japan","Tokyo-To","Koto-ku"],["Yamagata University Hospital","Nagase Satoru","Japan","Yamagata-Ken","Yamagata-shi"],["Mie University Hospital","Kondo Eiji","Japan","Mie-Ken","Tsu-shi"],["Niigata Cancer Center Hospital","Kikuchi Akira","Japan","Niigata-Ken","Niigata-shi"],["Kurume University Hospital","Nishio Shin","Japan","Fukuoka-Ken","Kurume-shi"],["NHO Kyushu Cancer Center","Ariyoshi Kazuya","Japan","Fukuoka-Ken","Fukuoka-shi"],["Tohoku University Hospital","Shigeta Shogo","Japan","Miyagi-Ken","Sendai-shi"],["Keio University Hospital","Yamagami Wataru","Japan","Tokyo-To","Shinjuku-ku"],["Fukushima Medical University Hospital","Soeda Shu","Japan","Fukushima-Ken","Fukushima-shi"],["NHO Hokkaido Cancer Center","Minobe Shinichiro","Japan","Hokkaido","Sapporo-shi"],["Gunma Prefectural Cancer Center","Nakamura Kazuto","Japan","Gunma-Ken","Ota-shi"],["Osaka International Cancer Institute","Kitai Miho","Japan","Osaka-Fu","Osaka-shi"],["Shizuoka Cancer Center","Kado Nobuhiro","Japan","Shizuoka-Ken","Sunto-gun"],["Seoul National University Hospital","Kim Jae-Weon","Korea, Republic of","Not Applicable","Seoul"],["Severance Hospital, Yonsei University Health System","Lee Jung-Yun","Korea, Republic of","Not Applicable","Seoul"],["National Cancer Center","Lim Myong Cheol","Korea, Republic of","Gyeonggi-do","Goyang-si"],["Seoul National University Bundang Hospital","Kim Kidong","Korea, Republic of","Gyeonggi-do","Seongnam"],["Gangnam Severance Hospital, Yonsei University Health System","Kim Jae Hoon","Korea, Republic of","Not Applicable","Seoul"],["Korea University Anam Hospital","Song Jae Yun","Korea, Republic of","Not Applicable","Seoul"],["Samsung Medical Center","Lee Yooyoung","Korea, Republic of","Not Applicable","Seoul"],["Asan Medical Center","Lee Shin-Wha","Korea, Republic of","Not Applicable","Seoul"],["Keimyung University Dongsan Hospital","Shin So-Jin","Korea, Republic of","Not Applicable","Daegu"],["Taichung Veterans General Hospital","Lu Chien-Hsing","中国台湾","NA","Taichung"],["Taipei Veterans General Hospital","Wang Peng-Hui","中国台湾","NA","Taipei"],["MacKay Memorial Hospital_ Taipei Branch","Chang Chih-Long","中国台湾","NA","Taipei"],["National Taiwan University Hospital","Wei Lin-Hung","中国台湾","NA","Taipei"],["National Cheng Kung University Hospital","Huang Yu-Fang","中国台湾","NA","Tainan"],["Gujarat Cancer & Research Institute","Panchal Harsha","India","Gujarat","Ahmedabad"],["HCG Cancer Centre Vadodara","Mahato Pinaki","India","Gujarat","Vadodara"],["Deenanath Mangeshkar Hospital and Research Centre","Deshmukh Chetan Dilip","India","Maharashtra","Pune"],["HCG Manavata Cancer Centre","Vasantrao Nagarkar Rajnish","India","Maharashtra","Nashik"],["Vardhman Mahavir Medical College & Safdarjung Hospital","Kalra Kaushal","India","Delhi","Delhi"],["Hemato Oncology Clinic Ahmedabad Rajpath Branch","Desai Chirag","India","Gujarat","Ahmedabad"],["All India Institute of Medical Sciences","Khurana Sachin","Israel","Delhi","New Delhi"],["The Lady Davis Carmel Medical Center","Segev Yakir","Israel","NA","Haifa"],["Wolfson Medical Center","Levy Tally","Israel","NA","Holon"],["Shaare Zedek","Rosengarten Ora","Israel","NA","Jerusalem"],["Tel Aviv Sourasky Medical Center","Safra Tamar","Israel","NA","Tel Aviv"],["Rambam Medical Center","Matanes Emad","Israel","NA","Haifa"],["Sheba Medical Center","Korach Jacob","Israel","NA","Ramat-Gan"],["Hadassah University Hospital - Ein Kerem","Perry Tamar","Israel","NA","Jerusalem"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["浙江省肿瘤医院医学伦理委员会","修改后同意","2025-06-24"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 130 ； 国际: 710 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；