上海注射用MK-2870III期临床试验-sac-TMT联合帕博利珠单抗序贯化疗联合帕博利珠单抗治疗早期TNBC或HR低表达/HER2- BC

登记号	CTR20253282	试验状态	进行中
申请人联系人	高蒙蒙	首次公示信息日期	2025-08-18
申请人名称	默沙东研发（中国）有限公司

登记号	CTR20253282
相关登记号	暂无
药物名称	注射用MK-2870
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	高危早期三阴性乳腺癌或激素受体低表达/人表皮生长因子受体2阴性乳腺癌
试验专业题目	一项评价sac-TMT（芦康沙妥珠单抗，MK-2870）联合帕博利珠单抗序贯卡铂/紫杉醇联合帕博利珠单抗对比化疗联合帕博利珠单抗作为高危早期三阴性乳腺癌或激素受体低表达/人表皮生长因子受体2 阴性乳腺癌的新辅助治疗的有效性和安全性的III 期、随机、开放性研究
试验通俗题目	sac-TMT联合帕博利珠单抗序贯化疗联合帕博利珠单抗治疗早期TNBC或HR低表达/HER2- BC
试验方案编号	MK-2870-032	方案最新版本号	00
版本日期:	2025-02-18	方案是否为联合用药	是

申请人名称	[["默沙东研发（中国）有限公司"]]
联系人姓名	高蒙蒙	联系人座机	010-58609035	联系人手机号	18911036968
联系人Email	Mengmeng.gao@merck.com	联系人邮政地址	北京市-北京市-朝阳区容达路21号	联系人邮编	100102

在既往未经治疗、经中心确认的高危早期TNBC或HR低表达/HER2- BC受试者中，评估MK-2870联合帕博利珠单抗序贯卡铂/紫杉醇联合帕博利珠单抗对比化疗联合帕博利珠单抗新辅助治疗的有效性和安全性

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	男+女
健康受试者	无
入选标准	[["既往未经治疗的高危早期非转移性（M0）乳腺癌，定义为由研究者基于影像学和/或临床评估，按照AJCC第8版乳腺癌分期标准，评估为以下原发性肿瘤（T）和局部淋巴结（N）分期组合：n- cT1c，N1-N2 n- cT2，N0-N2 n- cT3，N0-N2 n- cT4a-d，N0-N2"],["受试者必须患有经过中心确认的三阴性或HR低表达/HER2- BC（定义为ER为1%-10%的低表达且HER2阴性），符合最新的美国临床肿瘤学会（ASCO）/美国病理学会（CAP）指南。"],["能够提供符合要求的自原发乳腺肿瘤的空芯针活检组织样本。"],["男性需按照方案要求同意实施避孕措施。"],["女性需按照方案要求同意实施避孕措施。"],["受试者（或法律上接受的代理人）已提供本研究的书面知情同意书。"],["有HIV感染的受试者必须在ART治疗后HIV得到良好控制得以参加研究。"],["HBsAg阳性的受试者如果在随机分组前已接受至少4周的HBV抗病毒治疗并且HBV病毒载量低于检测下限，则有资格参加研究。"],["有HCV感染史的受试者如果筛选时HCV病毒载量低于检测下限，则有资格参加研究。"],["治疗随机分组前28天内的ECOG体能状态评分为0或1。"],["具有研究方案所定义的充分的器官功能。"],["有蒽环类药物用药史，需满足方案对于蒽环类药物终生累积剂量的限制要求。"]]
排除标准	[["有≥2级周围神经病变。"],["有记录的重度眼、睑板腺、角膜相关疾病病史。"],["患有需要免疫抑制药物治疗的活动性炎症性肠病，或有炎症性肠病既往史。"],["患有无法控制的重大心血管疾病或脑血管疾病。"],["患有未受控制的系统性疾病的受试者。"],["HIV感染受试者有卡波西肉瘤和/或多中心Castleman病的病史。"],["既往接受过抗PD-1、抗PD-L1或抗PD-L2药物或针对另一种刺激或协同抑制T细胞受体的药物治疗。"],["随机分组前4周内接受过系统性抗肿瘤治疗，包括试验用药物。"],["在研究干预首次给药前30天内接种过活疫苗或减毒活疫苗。允许接种灭活疫苗。"],["既往接受过靶向TROP2的ADC治疗。"],["既往接受过含拓扑异构酶I抑制剂的ADC治疗。"],["需要在研究干预首次给药前和整个研究期间接受CYP3A4强效抑制剂或诱导剂治疗。"],["既往接受过任何针对当前诊断BC的既往治疗。"],["有意向接受辅助内分泌治疗联合或不联合CDK4/6抑制剂治疗。"],["在研究干预给药前4周内接受过试验用药物治疗或使用过试验用器械。"],["有转移性（IV期）BC或cN3淋巴结受累。"],["在研究治疗前已接受原发性肿瘤切除活检、腋窝淋巴结清扫和/或腋窝前哨淋巴结活检。"],["被诊断为免疫缺陷，或在研究药物首次给药前正在接受长期全身性类固醇治疗。"],["已知患有在过去5年内正在进展或需要积极治疗的其他恶性肿瘤。"],["在过去2年内患有需要系统性治疗的活动性自身免疫性疾病。"],["有需要类固醇治疗的肺部炎症/间质性肺病病史或当前患有肺部炎症/间质性肺疾病。"],["有需要全身治疗的活动性感染。"],["并发活动性乙型肝炎和丙型肝炎病毒感染。"],["研究者认为参与研究不符合受试者的最佳利益。"],["对任何研究干预和/或其任何辅料有重度超敏反应。"],["干细胞/实体器官移植史。"],["受试者尚未从大手术中充分恢复或有持续的手术并发症。"]]

试验药	[["中文通用名:注射用MK-2870 英文通用名:MK-2870forinjection 商品名称:NA","剂型:注射剂 规格:200mg/瓶 用法用量:4mg/kg，Q2WIV输注 用药时程:新辅助治疗，共2周期"],["中文通用名:帕博利珠单抗注射液 英文通用名:PembrolizumabInjection 商品名称:可瑞达","剂型:注射剂 规格:100mg/4ml 用法用量:200mgQ3WIV输注；400mgQ6WIV输注 用药时程:新辅助治疗，共4周期；辅助治疗，共5周期"]] 序号 名称 用法
对照药	[["中文通用名:帕博利珠单抗注射液 英文通用名:PembrolizumabInjection 商品名称:可瑞达","剂型:注射剂 规格:100mg/4ml 用法用量:00mgQ3WIV输注；400mgQ6WIV输注 用药时程:新辅助治疗，共4周期；辅助治疗，共5周期"]] 序号 名称 用法

主要终点指标及评价时间	[["病理完全缓解率pCR（ypT0/Tis ypN0）","方案中规定的时间","有效性指标"],["无事件生存期（EFS）","方案中规定的时间","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（OS）","方案中规定的时间","有效性指标"],["病理完全缓解率pCR（ypT0 ypN0）","方案中规定的时间","有效性指标"],["无远处进展/无远处复发生存期（DPDRFS）","方案中规定的时间","有效性指标"],["安全性和耐受性","方案中规定的时间","安全性指标"],["EORTC QLQ-C30和EORTC QLQ-BR42中HRQoL较基线的平均变化","方案中规定的时间","有效性指标+安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	邵志敏	学位	博士	职称	正高级
	电话	021-64175590	Email	szmgcp2016@163.com	邮政地址	上海市-上海市-徐汇区东安路270号复旦大学附属肿瘤医院2号楼6楼
	邮编	200032	单位名称	复旦大学附属肿瘤医院

[["复旦大学附属肿瘤医院","邵志敏","中国","上海市","上海市"],["山东省肿瘤医院","王永胜","中国","山东省","济南市"],["浙江省肿瘤医院","俞洋","中国","浙江省","杭州市"],["浙江大学医学院附属第二医院","陈益定","中国","浙江省","杭州市"],["浙江省人民医院","孟旭莉","中国","浙江省","杭州市"],["江苏省人民医院","査小明","中国","江苏省","南京市"],["南京大学医学院附属鼓楼医院","姚永忠","中国","江苏省","南京市"],["南昌市人民医院（原南昌市第三医院）","李志华","中国","江西省","南昌市"],["武汉大学人民医院","姚峰","中国","湖北省","武汉市"],["广西医科大学附属肿瘤医院","杨华伟","中国","广西壮族自治区","南宁市"],["云南省肿瘤医院","聂建云","中国","云南省","昆明市"],["新疆医科大学附属肿瘤医院","李鸿涛","中国","新疆维吾尔自治区","乌鲁木齐市"],["安徽省肿瘤医院","洪士开","中国","安徽省","合肥市"],["河南省肿瘤医院","刘真真","中国","河南省","郑州市"],["华中科技大学同济医学院附属协和医院","刘春萍","中国","湖北省","武汉市"],["江门市中心医院","李晓平","中国","广东省","江门市"],["德阳市人民医院","贾新建","中国","四川省","德阳市"],["济南市中心医院","刘宪强","中国","山东省","济南市"],["广东省妇幼保健院","张安秦","中国","广东省","广州市"],["柳州市人民医院","莫军扬","中国","广西壮族自治区","柳州市"],["内江市第二人民医院","王绪娟","中国","四川省","内江市"],["临沂市肿瘤医院","王京芬","中国","山东省","临沂市"],["西安交通大学第一附属医院","王珂","中国","陕西省","西安市"],["北京肿瘤医院","范照青","中国","北京市","北京市"],["哈尔滨医科大学附属肿瘤医院","刘通","中国","黑龙江省","哈尔滨市"],["吉林大学第一医院","石爱平","中国","吉林省","长春市"],["厦门大学附属第一医院","欧阳忠","中国","福建省","厦门市"],["中南大学湘雅医院","胡煜","中国","湖南省","长沙市"],["湖南省肿瘤医院","胡小波","中国","湖南省","长沙市"],["Nagoya City University Hospital","Toyama, Tatsuya","日本","Aichi","Nagoya"],["Aichi Cancer Center","Hara, Fumikata","日本","Aichi","Nagoya"],["Akita University Hospital","Takahashi, Eriko","日本","Akita","Akita"],["Azienda Ospedaliero Universitaria delle Marche","Berardi, Rossana","意大利","Ancona","Ancona"],["Memorial Ankara Hastanesi","Demirci, Umut","土耳其","Ankara","Ankara"],["Instituto de Cancerología-Oncology","Zapata, Maycos","哥伦比亚","Antioquia","Medellin"],["Auckland City Hospital","Mesnage, Soizick","新西兰","Auckland","Auckland"],["University of Arizona Cancer Center","Ehsani, Sima","美国","AZ","Tucson"],["Banner MD Anderson Cancer Center","Khong, Hung","美国","AZ","Gilbert"],["Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont","Horvath, Zsolt","匈牙利","Bacs-Kiskun","Kecskemet"],["Institut Català d'Oncologia - L'Hospitalet","Villanueva Vazquez, Rafael","西班牙","Barcelona","L'Hospitalet De Llobregat"],["Parc de Salut Mar - Hospital del Mar","Martinez Garcia, Maria","西班牙","Barcelona","Barcelona"],["BC Cancer - Surrey","Kumar, Aalok","加拿大","BC","Surrey"],["ASST Papa Giovanni XXIII","Zambelli, Alberto","意大利","Bergamo","Bergamo"],["Hospital de Basurto","GALVE CALVO, ELENA","西班牙","Bizkaia","Bilbao"],["Borsod-Abaúj-Zemplén Vármegyei Kozponti Kórház és Egyetemi Oktatókórház","Dombovari, Gergely","匈牙利","Borsod-Abauj-Zemplen","Miskolc"],["Institut Paoli Calmettes.","Goncalves, Anthony","法国","Bouches-Du-Rhone","Marseille"],["Centre Georges Francois Leclerc","Ladoire, Sylvain","法国","Bourgogne","Dijon"],["Spitalul Clinic Filantropia","Median, Mircea","罗马尼亚","Bucuresti","Bucuresti"],["Országos Onkológiai Intézet-B-Belgyógyászati Onkológiai Osztály","Rubovszky, Gabor","匈牙利","Budapest","Budapest"],["Sanatorio Finochietto","KASSIS, NAIMA","阿根廷","Buenos Aires","Buenos Aires"],["Instituto de Investigaciones Clinicas Mar del Plata","Casarini, Ignacio","阿根廷","Buenos Aires","Mar Del Plata."],["Hoag Memorial Hospital Presbyterian","Nangia, Chaitali","美国","CA","Newport Beach"],["Roy and Patricia Disney Family Cancer Center","wong, karlton","美国","CA","Burbank"],["The Oncology Institute of Hope and Innovation","Mohammadi, Oranus","美国","CA","Whittier"],["Providence Medical Foundation","Lee, Monica","美国","CA","Fullerton"],["Hospital Italiano de Buenos Aires-ginecology","Riggi, Maria","阿根廷","Caba","Ciudad Autonoma De Buenos Aires"],["Centro de Educación Médica e Investigaciones clínicas","De la Vega, Maximo","阿根廷","Caba","Ciudad Autonoma De Buenos Aires"],["Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca","Rodriguez, Cesar","西班牙","Castilla Y Leon","Salamanca"],["AOU Renato Dulbecco","Tagliaferri, Pierosandro","意大利","Catanzaro","Catanzaro"],["PRONUTRIR","Braga, Virginia","巴西","Ceara","Fortaleza"],["COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI","Paramonov, Viktor","乌克兰","Cherkaska Oblast","Cherkasy"],["Municipal Enterprise Bukovinian сlinical oncology сenter","Pidverbetska, Anna","乌克兰","Cherkaska Oblast","Cherkasy"],["Maharaj Nakorn Chiang Mai Hospital","Somwangprasert, Areewan","泰国","Chiang Mai","Muang"],["Chiba Cancer Center","Nakamura, Rikiya","日本","Chiba","Chiba"],["Institutul Oncologic Cluj","Antone, Nicoleta","罗马尼亚","Cluj","Cluj"],["Intermountain Health St. Mary's Regional Hospital","Swink, Alicia","美国","CO","Grand Junction"],["Saint Joseph Hospital","Diab, Sami","美国","CO","Denver"],["Sanatorio Allende - Nueva Córdoba","Kim, Chong Hun","阿根廷","Cordoba","Cordoba"],["Sanatorio de la Canada - Córdoba","Diaz, Andrea","阿根廷","Cordoba","Cordoba"],["IMAT S.A.S","Lobatón Ramirez, José","哥伦比亚","Cordoba","Monteria"],["Szegedi Tudományegyetem Szent-Gy orgyi Albert Klinikai Kozpont-Onkoterapias Klinika","Nikolényi, Aliz","匈牙利","Csongrad","Szeged"],["All India Institute of Medical Sciences","Batra, Atul","印度","Delhi","New Delhi"],["Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia","RAMIREZ SIERRA, CARLOS","哥伦比亚","Distrito Capital De Bogota","Bogota"],["FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO","Franco Millan, Sandra","哥伦比亚","Distrito Capital De Bogota","Bogota"],["Centrul de Oncologie “Sfantul Nectarie”","Schenker, Michael","罗马尼亚","Dolj","Craiova"],["Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu","Sokolowski, Marcin","波兰","Dolnoslaskie","Walbrzych"],["Mayo Clinic Hospital","Chumsri, Saranya","美国","FL","Jacksonville"],["Bioresearch Partner","Rangel, Luis","美国","FL","Hialeah"],["Florida Cancer Specialists - North","Imam, Muhammad","美国","FL","St. Petersburg"],["Florida Cancer Specialists - South","Bustamante, Liliana","美国","FL","Fort Myers"],["Fukushima Medical University Hospital","Saji, Shigehira","日本","Fukushima","Fukushima"],["Sandton Oncology Medical Group (Pty) Ltd","Tabane, Neonyana","南非","Gauteng","Sandton"],["LIFE GROENKLOOF-Mary Potter Cancer Centre","Slabber, Coenraad","南非","Gauteng","Pretoria"],["Wits Clinical Research","Demetriou, Georgia","南非","Gauteng","Johannesburg"],["Hospital Araújo Jorge","Freitas-Junior, Ruffo","巴西","Goias","Goiania."],["MEDI-K","Alvarado Munoz, Juan","危地马拉","危地马拉","危地马拉"],["CELAN,S.A","Reyes Morales, Agatha","危地马拉","危地马拉","危地马拉"],["Onco Go, S.A","Barillas Ruiz, Allan","危地马拉","危地马拉","危地马拉"],["Asociacion Espanola de Beneficencia","Reynoso Lemus, Giovanni","危地马拉","危地马拉","危地马拉"],["INTEGRA Cancer Institute","Caceres Mendia, Claudia","危地马拉","危地马拉","危地马拉"],["K Hospital - National Cancer Hospital","Le, Thanh Duc","越南","Ha Noi","Hanoi"],["Hanoi Oncology Hospital","Nguyen, Duc Long","越南","Ha Noi","Hanoi"],["Mammazentrum HH - Krankenhaus Jerusalem","Schem, Christian","德国","Hamburg","Hamburg"],["Centre de Cancerologie du Grand Montpellier","Villanueva, Cristian","法国","Herault","Montpellier"],["Hiroshima City Hiroshima Citizens Hospital","Itoh, Mitsuya","日本","Hiroshima","Hiroshima"],["Ho Chi Minh City Oncology Hospital - Tan Phu Ward","Vo, Duc Hieu","越南","Ho Chi Minh","Thu Duc"],["Cho Ray Hospital","Nguyen, Thi Bich Lien","越南","Ho Chi Minh","Ho Chi Minh"],["National Hospital Organization Hokkaido Cancer Center","Watanabe, Kenichi","日本","Hokkaido","Sapporo"],["Institutul Regional de Oncologie","Gafton, Bogdan","罗马尼亚","Iasi","Iasi"],["Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology","de la Motte Rouge, Thibault","法国","Ille-Et-Vilaine","Rennes"],["Franciscan Health","Raghavendra, Meghana","美国","IN","Indianapolis"],["Fort Wayne Medical Oncology and Hematology","Vutukuri, Naga Malleswari","美国","IN","Fort Wayne"],["Koc Universitesi Hastanesi","Gunduz, Seyda","土耳其","Istanbul","Istanbul"],["Bakirkoy Dr. Sadi Konuk Training and Research Hospital","Yilmaz, Mesut","土耳其","Istanbul","Istanbul"],["CNCE Precarpathian Clinical Oncologic Center","Kryzhanivska, Anna","乌克兰","Ivano-Frankivska Oblast","Ivano-Frankivsk"],["HOSPITAL UNIVERSITARIO DE JAEN","Sanchez Rovira, Pedro","西班牙","Jaen","Jaén"],["Fundacion Ars Medica","Salvatierra, Alejandro","阿根廷","Jujuy","San Salvador De Jujuy"],["Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO)","Valentin Bejarano, John","秘鲁","Junin","Concepcion"],["Kanagawa Cancer Center","Yamashita, Toshinari","日本","Kanagawa","Yokohama"],["Erciyes University","Inanc, Mevlude","土耳其","Kayseri","Kayseri"],["CNE Regional clinical oncology center of Kirovograd regional Council","Iskimzhy, Dmytro","乌克兰","Kirovohradska Oblast","Kropyvnytskyi"],["Faculty of Medicine Siriraj Hospital","Soparattanapaisarn, Nopadol","泰国","Krung Thep Maha Nakhon","Bangkok"],["Chulalongkorn University","Parinyanitikul, Napa","泰国","Krung Thep Maha Nakhon","Pathumwan"],["Pantai Hospital Kuala Lumpur","Abdul Satar, Nur Fadhlina","马来西亚","Kuala Lumpur","Kuala Lumpur"],["University Malaya Medical Centre.","Alip, Adlinda","马来西亚","Kuala Lumpur","Lembah Pantai"],["Centrum Onkologii im. Prof. Franciszka Lukaszczyka","Zurawski, Bogdan","波兰","Kujawsko-Pomorskie","Bydgoszcz"],["Nonprofit Organization National Cancer Institute","Kondtratskyi, Yurii","乌克兰","Kyivska Oblast","Kyiv"],["National Cancer Center","Sim, Sung Hoon","韩国","Kyonggi-Do","Goyang-Si"],["Seoul National University Bundang Hospital","Kim, Jee Hyun","韩国","Kyonggi-Do","Kyonggi-Do"],["Kyoto University Hospital","Masuda, Norikazu","日本","Kyoto","Kyoto"],["Ochsner Clinic Foundation","Sheen, Melanie","美国","LA","New Orleans"],["Louisiana State University Health Sciences Shreveport","Burton, Gary","美国","LA","Shreveport"],["CHUS - Hospital Clinico Universitario","Lopez Lopez, Rafael","西班牙","La Coruna","Santiago De Compostela"],["Instituto Regional de Enfermedades Neoplásicas Del Norte","Galvez, Marco","秘鲁","La Libertad","Trujillo"],["Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman","Rorive, Andree","比利时","Luik","Genova"],["Ospedale San Martino","Del Mastro, Lucia","意大利","Genova","Lima"],["IPOR Instituto Peru ano de Oncología & Radioterapia","Leiva, Manuel","秘鲁","Lima","Lima"],["Hospital Guillermo Almenara Irigoyen","Milla, Dency","秘鲁","Lima","Lima"],["Hospital Nacional Edgardo Rebagliati Martins","Li Torres, Walter","秘鲁","Lima","Lima"],["Oncosalud","Gomez, Henry","秘鲁","Lima","Lima"],["INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS","Valencia, Guillermo","秘鲁","Lima","Lima"],["Salve Medica sp. z o.o. sp. k.","Kukulska, Monika","波兰","Lodzkie","Lodz"],["HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID","Gonzalez Cortijo, Lucia","西班牙","Madrid","Pozuelo De Alarcon"],["Ruby Hall Clinic","Jain, Minish","印度","Maharashtra","Pune"],["Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie","Grela-Wojewoda, Aleksandra","波兰","Malopolskie","Krakow"],["Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie","Nowecki, Zbigniew","波兰","Mazowieckie","Warszawa"],["Mercy Medical Center - Baltimore","Riseberg, David","美国","MD","Baltimore"],["New England Cancer Specialists","Battelli, Chiara","美国","ME","Westbrook"],["Mie University Hospital","Kawaguchi, Kosuke","日本","Mie","Tsu"],["Fondazione IRCCS Istituto Nazionale dei Tumori di Milano","Vernieri, Claudio","意大利","Milano","Milano"],["Hospital Mario Penna","Toledo, Joseane","巴西","Minas Gerais","Belo Horizonte"],["Washington University Siteman Cancer Center","Ademuyiwa, Foluso","美国","MO","St Louis"],["Saint Luke's Cancer Institute","Gast, Kelly","美国","MO","Kansas City"],["Queen Mary Hospital","Hui, Rina","中国香港","N/A","Pokfulam"],["Prince of Wales Hospital","Yeo, Winnie","中国香港","N/A","Shatin"],["Princess Margaret Hospital","Shum, Chui Yu","中国香港","N/A","Lai Chi Kok"],["Tuen Mun Hospital","Ng, Ting Ying","中国香港","N/A","Tuen Mun"],["香港 United Oncology Centre","Chiu, Wing Yan Joanne","中国香港","N/A","Jordan"],["Rambam Health Care Campus","Shai, Ayelet","爱尔兰","N/A","Haifa"],["Sheba Medical Center","Nili-Gal-Yam, Einav","爱尔兰","N/A","Ramat Gan"],["Meir Medical Center.","Kuchuk, Iryna","爱尔兰","N/A","Kfar Saba"],["Yitzhak Shamir Medical Center.","Merose, Rotem","爱尔兰","N/A","Zerifin"],["CHU UCL Namur/Site Sainte Elisabeth","Taylor, Donatienne","比利时","Namur","Namur"],["THE MEDICAL CITY","Bautista, Janet","菲律宾","National Capital Region","Pasig City"],["Makati Medical Center","Tamayo, Maria Belen","菲律宾","National Capital Region","Makati"],["Rex Hematology Oncology Associates","Rauch, Julia","美国","NC","Raleigh"],["Altru Health System","Seeger, Grant","美国","ND","Grand Forks"],["Cancer Partners of Nebraska","Tilford, Joni","美国","NE","Lincoln"],["Westmead Hospital","Dinh, Phuong","澳大利亚","New South Wales","Westmead"],["Macquarie University","Sabanathan, Dhanusha","澳大利亚","New South Wales","North Ryde"],["Chris O'Brien Lifehouse","Kumar, Sanjeev","澳大利亚","New South Wales","Camperdown"],["Hackensack Univ Medical Center (HUMC)","Graham, Deena","美国","NJ","Hackensack"],["Rutgers Cancer Institute of New Jersey","George, Mridula","美国","NJ","New Brunswick"],["St. Vincenz-Krankenhaus Frauen- und Kinderklinik","Lux, Michael","德国","Nordrhein-Westfalen","Paderborn"],["Universit？tsklinikum Münster - Albert Schweitzer Campus","Tio, Joke","德国","Nordrhein-Westfalen","Muenster"],["Renown Regional Medical Center","Schwartzberg, Lee","美国","NV","Reno"],["Cleveland Clinic - Ohio","Barot, Shimoli","美国","ON","Cleveland"],["Good Samaritan Hospital-TriHealth Cancer institute","Shatavi, Seerin","美国","ON","Cincinnati"],["The Ottawa Hospital Cancer Centre","Song, Xinni","加拿大","ON","Ottawa"],["Mount Sinai Hospital","Brezden-Masley, Christine","加拿大","ON","Toronto"],["Lakeridge Health","Chandhoke, Gursimran","加拿大","ON","Oshawa"],["Sault Area Hospital","Spadafora, Silvana","加拿大","ON","Sault Ste. Marie"],["Royal Victoria Regional Health Centre","Veitch, Zachary","加拿大","ON","Barrie"],["UZ Gent","Naert, Eline","比利时","Oost-Vlaanderen","Gent"],["SP ZOZ Opolskie Centrum Onkologii im. prof. T. Koszarowskiego w Opolu","Radecka, Barbara","波兰","Opolskie","Opole"],["The University of Osaka Hospital","Yoshinami, Tetsuhiro","日本","Osaka","Suita"],["National Hospital Organization Osaka National Hospital","Yasojima, Hiroyuki","日本","Osaka","Osaka"],["Kindai University Hospital","Watanabe, Satomi","日本","Osaka","Osakasayama"],["Kansai Medical University Hospital","Takada, Masahiro","日本","Osaka","Hirakata"],["Istituto Oncologico Veneto IRCCS","Guarneri, Valentina","意大利","Padova","Padova"],["Institut Curie","Loirat, Delphine","法国","Paris","Paris"],["Tampereen ylipistollinen sairaala","Maenpaa, Niina","芬兰","Pirkanmaa","Tampere"],["Azienda Ospedaliero Universitaria Pisana","Bengala, Carmelo","意大利","Pisa","Pisa"],["Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie","Hermanowicz-Szamatowicz, Kinga","波兰","Podlaskie","Bialystok"],["Oulun yliopistollinen sairaala","Iivanainen, Sanna","芬兰","Pohjois-Pohjanmaa","Oulu"],["Wojewódzki Szpital Specjalistyczny im. J. Korczaka w S？upsku","Rogowski, Wojciech","波兰","Pomorskie","Slupsk"],["Hospital Pulau Pinang","Lee, Cheen Leng","马来西亚","Pulau Pinang","George Town"],["Jewish General Hospital","Boileau, Jean-Francois","加拿大","QC","Montreal"],["Centre Hospitalier de l'Université de Montréal","Younan, Rami","加拿大","QC","Montreal"],["McGill University Health Centre","Soldera, Sara","加拿大","QC","Montreal"],["CHU de Quebec Universite Laval - Hopital du Saint-Sacrement","Poirier, Brigitte","加拿大","QC","Quebec"],["Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec","Aucoin, Jean Sebastien","加拿大","QC","Trois-Rivières"],["Arcispedale Santa Maria Nuova","Giovanardi, Filippo","意大利","Reggio Emilia","Reggio Emilia"],["FALP","Reyes, Felipe","智利","Region M. De Santiago","Santiago"],["Bradfordhill","Gallardo, Carlos","智利","Region M. De Santiago","Santiago"],["Centro de Estudios Clínicos SAGA","Garrido, Marcelo","智利","Region M. De Santiago","Santiago"],["InVO Institut für Versorgungsforschung in der Onkologie","Weide, Rudolf","德国","Rheinland-Pfalz","Koblenz"],["centre hospitalier lyon sud","Peron, Julien","法国","Rhone","Pierre-Benite"],["Liga Norte Riograndense Contra o Cancer","Aquino Pimentel, Luciana","巴西","Rio Grande Do Norte","Natal"],["Hospital Sao Lucas da PUCRS","Damian, Fernanda","巴西","Rio Grande Do Sul","Porto Alegre"],["Oncologos del Occidente","Arenas Arias, Andres Fernando","哥伦比亚","Risaralda","Pereira"],["Fondazione Policlinico Universitario Agostino Gemelli IRCCS – Università Cattolica del Sacro Cuore","PARIS, IDA","意大利","Roma","Roma"],["Istituto Nazionale Tumori Regina Elena","Calabro, Fabio","意大利","Roma","Roma"],["CaritasKlinikum Saarbrücken St. Theresia","Deryal, Mustafa","德国","Saarland","Saarbrücken"],["Sanatorio Parque","Fruci, Luisina","阿根廷","Santa Fe","Rosario."],["Hospital de Base de Sao José do Rio Preto","Guedes, Jo？o Daniel","巴西","Sao Paulo","Sao Jose Do Rio Preto"],["Fundacao Pio XII - Hospital de Cancer de Barretos","Paiva, Carlos","巴西","Sao Paulo","Barretos"],["Sarawak General Hospital","WAN MAHARUDDIN, IZZATI BINTI","马来西亚","Sarawak","Kuching"],["Medical University of South Carolina-Hollings Cancer Center","Sivapiragasam, Abirami","美国","SC","Charleston"],["Lübecker Onkologische Schwerpunktpraxis","Kisro, Jens","德国","Schleswig-Holstein","Luebeck"],["Avera McKennan Hospital","Higgins, Alexandra","美国","SD","Sioux Falls"],["Avera Cancer Institute - Yankton","Higgins, Alexandra","美国","SD","Yankton"],["The Catholic University of Korea. Seoul St. Mary s Hospital","Lee, Jieun","韩国","Seoul","Seoul"],["Asan Medical Center","Kim, Sung-Bae","韩国","Seoul","Seoul"],["Severance Hospital Yonsei University Health System","Sohn, Joo Hyuk","韩国","Seoul","Seoul"],["Seoul National University Hospital","Im, Seock-Ah","韩国","Seoul","Seoul"],["Samsung Medical Center","Park, Yeon Hee","韩国","Seoul","Seoul"],["Hospital Universitario Virgen Macarena","de la Cruz Merino, Luis","西班牙","Sevilla","Sevilla"],["Shizuoka Cancer Center","Nishimura, Seiichiro","日本","Shizuoka","Sunto-Gun"],["Skanes Universitetssjukhus Malmo","Narbe, Ulrik","瑞典","Skane Lan","Lund"],["CHU d'Amiens-Picardie - Hopital Sud","Moreira, Aurelie","法国","Somme","Amiens"],["Songklanagarind Hospital","Sathitruangsak, Chirawadee","泰国","Songkhla","Hat Yai"],["Karolinska Universitetssjukhuset Solna","Foukakis, Theodoros","瑞典","Stockholms Lan","Stockholm"],["Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch","Zubrowska, Justyna","波兰","Swietokrzyskie","Kielce"],["Kyungpook National University Chilgok Hospital","Chae, Yee Soo","韩国","Taegu-Kwangyokshi","Taegu"],["Taichung Veterans General Hospital","Hung, Chih-Chiang","中国台湾","Taichung","Taichung"],["National Taiwan University Hospital","Lu, Yen-Shen","中国台湾","Taipei","Taipei"],["National Taiwan University Cancer Center (NTUCC)","Wang, Ming-Yang","中国台湾","Taipei","Taipei"],["MacKay Memorial Hospital","Chang, Yuan-Ching","中国台湾","Taipei","Taipei"],["Chang Gung Medical Foundation-Linkou Branch","Chen, Shin-Cheh","中国台湾","Taoyuan","Taoyuan"],["Cabinet Medical Oncomed","Oprean, Cristina","罗马尼亚","Timis","Timisoara"],["Nashville General Hospital","Jacob, Robin","美国","TN","Nashville"],["Vanderbilt Breast Center","Kennedy, Laura","美国","TN","Nashville"],["Tennessee Cancer Specialists","Schumaker, David","美国","TN","Knoxville"],["Cancer Institute Hospital of JFCR","Takano, Toshimi","日本","Tokyo","Koto"],["Showa Medical University Hospital","Hayashi, Naoki","日本","Tokyo","Shinagawa"],["Toranomon Hospital","Tanabe, Yuko","日本","Tokyo","Minato"],["Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L","Vega, Natalia","阿根廷","Tucuman","San Miguel De Tucuman"],["Hendrick Medical Center","Khalife, Mustapha","美国","TX","Abilene"],["Kelsey Research Foundation","Patel, Sunil","美国","TX","Houston"],["Oncology Consultants P.A.","Alvarez, Ricardo","美国","TX","Houston"],["JPS Oncology and Infusion Center","Narra, Kalyani","美国","TX","Fort Worth"],["Texas Tech University Health Sciences Center","Daniele, Karla","美国","TX","Lubbock"],["Kelsey Research Foundation","Patel, Sunil","美国","TX","Houston"],["Texas Oncology - San Antonio","Aponte-Garcia, Emmalind","美国","TX","San Antonio"],["Akademiska sjukhuset","Schiza, Aglaia","瑞典","Uppsala Lan","Uppsala"],["Intermountain Medical Center","Van Meter, Margaret","美国","UT","Murray"],["Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syopakeskus)","Karihtala, Peeter","芬兰","Uusimaa","Helsinki"],["Bon Secours Cancer Institute at St. Francis","Irvin, William","美国","VA","Midlothian"],["Oncology and Hematology Associates of Southwest Virginia (BRCC)","Gillespie-Twardy, Amanda","美国","VA","Roanoke"],["HENRI MONDOR HOSPITAL","assaf, elias","法国","Val-De-Marne","Creteil"],["Hospital General de Valencia","IRANZO, VEGA","西班牙","Valenciana, Comunitat","Creteil"],["Fundación Valle del Lili","Ortiz Diaz, Juan","哥伦比亚","Valle Del Cauca","Creteil"],["ONCOCENTRO APYS","Acevedo, Alejandro","智利","Valparaiso","Vina Del Mar"],["Sodra Alvsborgs Sjukhus Boras","Einbeigi, Zakaria","瑞典","Vastra Gotalands Lan","Bor？s"],["Monash Health","White, Michelle","澳大利亚","Victoria","Clayton"],["Cancer Care Northwest","Thumma, Saritha","美国","WA","Spokane"],["Northwest Medical Specialties, PLLC","Blau, Sibel","美国","WA","Tacoma"],["Fred Hutchinson Cancer Center","Symonds, Lynn","美国","WA","Seattle"],["Szpital Kliniczny Ministerstwa Spraw Wewn？trznych i Administracji z Warmińsko-Mazurskim Centrum Onko","Kotyla, Monika","波兰","Warminsko-Mazurskie","Olsztyn"],["Bowen Hospital","Okonji, David","新西兰","Wellington","Wellington"],["Breast Cancer Research Centre-WA","Khan, Azim","澳大利亚","Western Australia","Nedlands"],["Cancercare Rondebosch Oncology","Sirkhotte, Aqeela","南非","Western Cape","Rondebosch"],["University of Wisconsin-Madison","Qamar, Rubina","美国","WI","Madison"],["National Cancer Institute","Wong, Yoke Fui","马来西亚","Wilayah Persekutuan Putrajaya","Putrajaya"],["Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie","Kwiatkowski, Mariusz","波兰","Zachodniopomorskie","Koszalin"],["Zala Vármegyei Szent Rafael Kórház-Onkológiai osztály","Mahr, Karoly","匈牙利","Zala","Zalaegerszeg"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["复旦大学附属肿瘤医院医学伦理委员会","同意","2025-05-23"]]

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: 260 ； 国际: 2400 ；
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：2025-06-30；
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；