北京帕博利珠单抗注射液III期临床试验-sac-TMT联合帕博利珠单抗作为pMMR型子宫内膜癌的1L维持治疗

登记号	CTR20252559	试验状态	进行中
申请人联系人	张新建	首次公示信息日期	2025-07-02
申请人名称	默沙东研发（中国）有限公司

登记号	CTR20252559
相关登记号	暂无
药物名称	帕博利珠单抗注射液
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	一项在错配修复基因完整的子宫内膜癌受试者中比较芦康沙妥珠单抗（MK-2870，sac-TMT）联合帕博利珠单抗与帕博利珠单抗单药作为一线维持治疗有效性和安全性的III期、随机、开放性、多中心研究
试验通俗题目	sac-TMT联合帕博利珠单抗作为pMMR型子宫内膜癌的1L维持治疗
试验方案编号	TroFuse-033	方案最新版本号	01
版本日期:	2025-01-30	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	张新建	联系人座机	010-58609542	联系人手机号
联系人Email	xin.jian.zhang@merck.com	联系人邮政地址	北京市-北京市-北京市朝阳区容达路21号楼	联系人邮编	100012

在未接受过化疗和/或抗PD-1/PD-L1治疗作为晚期或转移性疾病一线治疗的pMMR原发性晚期或复发性子宫内膜癌受试者中比较芦康沙妥珠单抗（MK-2870，sac-TMT）联合帕博利珠单抗与帕博利珠单抗单药的有效性和安全性

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	[["受试者必须有组织学确诊的原发性晚期或复发性子宫内膜癌，并且已通过当地病理学确认为pMMR。"],["存在研究者根据RECIST 1.1评估的影像学可评价病灶，可测量的III期或可测量/不可测量的IV期或复发性疾病。位于既往放疗照射区域的病灶，如果已经出现进展，则认为该病灶是可测量的。"],["既往未接受过针对子宫内膜癌的系统治疗，以下情况除外：既往可能在根治治疗阶段，接受过1个治疗线的以铂类为基础的系统性辅助和/或新辅助化疗。在诱导治疗开始前＞2周，可接受过放疗伴或未伴放射增敏的化疗。如果既往接受过内分泌疗法治疗子宫内膜癌，则必须在诱导治疗开始前≥1周终止。"]]
排除标准	[["患有癌肉瘤、神经内分泌肿瘤或子宫内膜肉瘤，包括间质肉瘤、平滑肌肉瘤、腺肉瘤或其他类型的肉瘤。"],["患有任何组织学类型的dMMR子宫内膜癌。"],["入组时为根治性手术或根治性放疗的候选者。"],["重度干眼症、重度睑板腺疾病和/或睑缘炎或妨碍/延缓角膜愈合的角膜疾病的有记录的病史。"],["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。"],["有未控制的重大心血管疾病或脑血管疾病。"],["有卡波西肉瘤和/或多中心型Castleman病病史的HIV感染者。"],["既往任何治疗线中接受过抗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。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。"]]

试验药

[["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:诱导治疗：200mg，Q3W;维持治疗：400mg，Q6W； 用药时程:用药时程：诱导治疗：共6个周期；维持治疗：共14个周期；"],["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,每6周一个周期，第1、15和29天 用药时程:维持治疗：最多持续14个周期（最长约19个月）；"],["中文通用名:卡铂注射液 英文通用名:CarboplatinInjection 商品名称:伯尔定","剂型:注射剂 规格:150mg/15mL 用法用量:诱导治疗：AUC5，Q3W 用药时程:诱导治疗：共6个周期"],["中文通用名:紫杉醇注射液 英文通用名:PaclitaxelInjection 商品名称:泰素","剂型:注射剂 规格:30mg/5mL 用法用量:诱导治疗：175mg/m2，Q3W 用药时程:诱导治疗：共6个周期"],["中文通用名:多西他赛注射液 英文通用名:DocetaxelInjection 商品名称:泰索帝","剂型:注射剂 规格:20mg/0.5mL 用法用量:诱导治疗代替紫杉醇：75mg/m2，Q3W 用药时程:诱导治疗：共6个周期"]] 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:诱导治疗：200mg，Q3W;维持治疗：400mg，Q6W； 用药时程:诱导治疗：共6个周期；维持治疗：共14个周期；"],["中文通用名:卡铂注射液 英文通用名:CarboplatinInjection 商品名称:伯尔定","剂型:注射剂 规格:150mg/15mL 用法用量:诱导治疗：AUC5，Q3W 用药时程:诱导治疗：共6个周期"],["中文通用名:紫杉醇注射液 英文通用名:PaclitaxelInjection 商品名称:泰素","剂型:注射剂 规格:30mg5mL 用法用量:诱导治疗：175mg/m2，Q3W 用药时程:诱导治疗：共6个周期"],["中文通用名:多西他赛注射液 英文通用名:DocetaxelInjection 商品名称:泰索帝","剂型:注射剂 规格:20mg/0.5mL 用法用量:诱导治疗代替紫杉醇：75mg/m2，Q3W 用药时程:诱导治疗：共6个周期"]] 序号 名称 用法

主要终点指标及评价时间	[["维持治疗：无进展生存期(PFS)","最长约44个月","有效性指标"],["维持治疗：总生存期(OS)","最长约54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	[["维持治疗：研究者评估的无进展生存期2（PFS2）","最长约54个月","有效性指标"],["维持治疗：研究者评估的无进展生存期2（PFS2）","最长约27个月","安全性指标"],["维持治疗：EORTC QLQ-C30总体健康状况/生活质量评分、身体功能评分、角色功能评分较基线的变化","最长约24个月","有效性指标+安全性指标"],["维持治疗：EORTC QLQ-EN24背部和盆腔疼痛评分较基线的变化","最长约24个月","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	王建六	学位	医学博士	职称	主任医师
	电话	010-88324383	Email	wangjianliu1203@163.com	邮政地址	北京市-北京市-北京市
	邮编	100044	单位名称	北京大学人民医院

[["北京大学人民医院","王建六","中国","北京市","北京市"],["浙江大学医学院附属妇产科医院","吕卫国","中国","浙江省","杭州市"],["重庆大学附属肿瘤医院","王冬","中国","重庆市","重庆市"],["山西省肿瘤医院","赵宏伟","中国","山西省","太原市"],["中山大学肿瘤防治中心","李俊东","中国","广东省","广州市"],["中南大学湘雅医院","张瑜","中国","湖南省","长沙市"],["厦门大学附属第一医院","陈琼华","中国","福建省","厦门市"],["广东医科大学附属医院","廖思海","中国","广东省","广州市"],["温州医科大学附属第一医院","胡燕","中国","浙江省","温州市"],["河南省肿瘤医院","王莉","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","李贵玲","中国","湖北省","武汉市"],["广西医科大学附属肿瘤医院","姚德升","中国","广西壮族自治区","南宁市"],["湖南省肿瘤医院","唐洁","中国","湖南省","长沙市"],["江西省妇幼保健院","安云婷","中国","江西省","南昌市"],["福建省肿瘤医院","林安","中国","福建省","福州市"],["中山大学孙逸仙纪念医院","张丙忠","中国","广东省","广州市"],["云南省肿瘤医院","杨宏英","中国","云南省","昆明市"],["汕头大学医学院附属肿瘤医院","李从铸","中国","广东省","汕头市"],["南京市第一医院","魏晓为","中国","江苏省","南京市"],["南方医科大学珠江医院","王沂峰","中国","江苏省","南京市"],["安徽省立医院","周颖","中国","安徽省","合肥市"],["吉林大学第一医院","张松灵","中国","吉林省","长春市"],["西安交通大学医学院第一附属医院","安瑞芳","中国","陕西省","西安市"],["哈尔滨医科大学附属肿瘤医院","张云艳","中国","黑龙江省","哈尔滨市"],["山东省肿瘤医院","于浩","中国","山东省","济南市"],["柳州市人民医院","贺婵娟","中国","广西壮族自治区","柳州市"],["复旦大学附属妇产科医院","罗雪珍","中国","上海市","上海市"],["郑州大学第二附属医院","赵虎","中国","河南省","郑州市"],["宜宾市第二人民医院","汪善兵","中国","四川省","宜宾市"],["上海市第十人民医院","陈晓军","中国","上海市","上海市"],["台州恩泽医疗中心（集团）","杨海华","中国","浙江省","台州市"],["四川大学华西第二医院（四川大学华西妇产儿童医院","尹如铁","中国","四川省","成都市"],["Instituto de Oncología Angel H. Roffo","Caceres, Maria","阿根廷","Buenos Aires","Ciudad Autonoma de Buenos Aires"],["Hospital Británico de Buenos Aires","Vera, Karina","阿根廷","CABA","CABA"],["Exelsus - Oncología Clínica","Zarba, Juan","阿根廷","Tucuman","San Miguel de Tucuman"],["Instituto Alexander Fleming","Giornelli, Gonzalo","阿根廷","Buenos Aires","Ciudad Autónoma de Buenos Aires"],["Instituto San Marcos","Yanzi Castilla, Alvaro","阿根廷","San Juan","San Juan"],["Instituto de Investigaciones Clínicas Mar del Plata","Casarini, Ignacio","阿根廷","Buenos Aires","Mar del Plata"],["Blacktown Hospital","Gao, Bo","澳大利亚","New South Wales","Blacktown"],["Monash Health","Frentzas, Sophia","澳大利亚","Victoria","Clayton"],["Sir Charles Gairdner Hospital","Meniawy, Tarek","澳大利亚","Western Australia","Nedlands"],["Mater Misericordiae Ltd","Shannon, Catherine","澳大利亚","Queensland","South Brisbane"],["Cancer Research SA-St Andrews Hospital","Okera, Meena","澳大利亚","South Australia","Adelaide"],["Royal Brisbane and Women's Hospital","Goh, Jeffrey","澳大利亚","Queensland","Brisbane"],["Epworth Freemasons","Ananda, Sumitra","澳大利亚","Victoria","Brisbane"],["GenesisCare North Shore","Baron-Hay, Sally","澳大利亚","New South Wales","St Leonards"],["Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gyn？kologie und Geburtshilfe","Marth, Christian","澳大利亚","Tirol","Innsbruck"],["DZU - Diagnosezentrum Urania Radiology","Concin, Nicole","澳大利亚","Wien","Vienna"],["Medizinische Universit？t Graz-Abteilung für Gyn？kologie / Onkologie","Kolovetsiou Kreiner, Vassiliki","澳大利亚","Steiermark","Graz"],["Van Gorp, Toon","UZ Leuven","比利时","Vlaams-Brabant","Leuven"],["AZ Maria Middelares","Vulsteke, Christof","比利时","Oost-Vlaanderen","Gent"],["Grand H？pital de Charleroi","Devaux, Alix","比利时","Hainaut","Hainaut"],["CHU de Liege","Gennigens, Christine","比利时","wallonne, Region","Liège"],["CHU Saint-Pierre","Martinez-Mena, Corina","比利时","Bruxelles-Capitale, Region de","Brussels"],["Instituto Nacional de Cancer - INCA","Melo, Andreia Cristina de","巴西","Rio de Janeiro","Rio de Janeiro"],["Hospital Amaral Carvalho","Beato, Patricia","巴西","Jau","Sao Paulo"],["CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia","Santi, Patricia","巴西","Sao Paulo","Santo Andre"],["Funda？？o Faculdade Regional de Medicina de S？o José do Rio Preto","Ferrari, Camila","巴西","Sao Paulo","Sao Jose do Rio Preto"],["Hospital Felicio Rocho","Costa, Renata","巴西","Minas Gerais","Belo Horizonte"],["Hospital das Clínicas da Faculdade de Medicina de Ribeir？o Preto da Universidade de S？o Paulo (USP)","Candido dos Reis, Francisco José","巴西","Sao Paulo","Ribeirao Preto"],["Hospital Araújo Jorge","Freitas-Junior, Ruffo","巴西","Goias","Goiania."],["Hospital S？o Lucas da PUCRS","Damian, Fernanda","巴西","Rio Grande do Sul","Porto Alegre"],["Liga Norte Riograndense Contra o Cancer","Gomes, Andrea","巴西","Rio Grande do Norte","Natal"],["Funda？？o Pio XII - Hospital de Cancer de Barretos","Oikawa, Karina","巴西","Sao Paulo","Barretos"],["IBCC - Instituto Brasileiro de Controle do Cancer","Barros, Lilian","巴西","Sao Paulo","Sao Paulo"],["QEII Health Sciences Centre – Victoria General Site","Willows, Karla","加拿大","NS","Halifax"],["Dr. H. Bliss Murphy Cancer Centre","Neveu, Joannie","加拿大","NL","St. John's"],["Centre intégré de cancérologie du CHU de Québec Université Laval, H？pital de l'Enfant-Jésus","Castonguay, Vincent","加拿大","QC","Québec"],["McGill University Health Centre","Mandilaras, Victoria","加拿大","QC","Montreal"],["Centre Hospitalier de l Universite de Montreal - CHUM","Samouelian, Vanessa","加拿大","QC","Montreal"],["Jewish General Hospital","Lau, Susie","加拿大","QC","Montreal"],["Fortin, Suzanne","CIUSSS de l'Est-de-l'le-de-Montréal","加拿大","QC","Montreal"],["Centre intégré universitaire de santé et de services sociaux de l'Estrie – Centre Hospitalier Univer","Bessette, Paul","加拿大","QC","Sherbrooke"],["Princess Margaret Cancer Center","Oza, Amit","加拿大","ON","Toronto"],["Sunnybrook Research Institute","MacKay, Helen","加拿大","ON","Toronto"],["Lawson Health Research Institute","Jang, Ji-Hyun","加拿大","ON","London"],["Thunder Bay Regional Health Sciences Centre","Aseyev, Olexiy","加拿大","ON","Thunder Bay"],["Hamilton Health Sciences-Juravinski Cancer Centre","Jimenez, Waldo","加拿大","ON","Hamilton"],["Windsor Regional Cancer Program","Elfiki, Tarek","加拿大","ON","Windsor"],["Royal Victoria Regional Health Centre","White, Laura","加拿大","ON","Barrie"],["Sault Area Hospital","Spadafora, Silvana","加拿大","ON","Sault Ste. Marie"],["CancerCare Manitoba","Altman, Alon","加拿大","MB","Winnipeg"],["Saskatoon Cancer Centre","Brown Broderick, Jennifer","加拿大","SK","Regina"],["Cross Cancer Institute","Sabourin, Jeanelle","加拿大","AB","Edmonton"],["BC Cancer Vancouver","Tinker, Anna","加拿大","BC","Vancouver"],["BC Cancer Surrey","Kumar, Aalok","加拿大","BC","Surrey"],["Health Sciences North","Pitre, Lacey","加拿大","ON","Sudbury"],["CIDO SpA","Rey Gonzalez, Felipe","智利","Araucania","Temuco"],["FALP","Cid, Fernando","智利","Region M. de Santiago","Santiago"],["Bradfordhill","Gallardo, Carlos","智利","Region M. de Santiago","Santiago"],["ONCOCENTRO APYS","Acevedo, Alejandro","智利","Valparaiso","Vina del Mar"],["Pontificia Universidad Catolica de Chile-Centro del Cáncer","Ibanez, Carolina","智利","Region M. de Santiago","Santiago"],["Clínica Puerto Montt","Painemal, Claudio","智利","Los Lagos","Puerto Montt."],["Centro de Estudios Clínicos SAGA","Garrido, Marcelo","智利","Region M. de Santiago","Santiago"],["IC La Serena Research","Ojeda Escalona, Maria Alejandra","智利","Coquimbo","La Serena"],["Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia","Ramos Guette, Pedro","哥伦比亚","Distrito Capital de Bogota","Bogota"],["FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO","Pierre, Marc","哥伦比亚","Distrito Capital de Bogota","Bogota"],["Fundación Valle del Lili","Franco Climent, William","哥伦比亚","Valle del Cauca","Cali."],["Instituto de Cancerología S.A.S","Graciano, Noiver","哥伦比亚","Antioquia","Medellin"],["Fundacion Colombiana de Cancerología Clinica Vida","Sanchez, Tomas","哥伦比亚","Antioquia","Medellin"],["Clinica Somer-Unidad de Investigacion y Docencia","Vallejo, Camilo","哥伦比亚","Antioquia","Rionegro"],["Oncologos Del Occidente","Arenas Arias, Andres Fernando","哥伦比亚","Risaralda","Pereira."],["Oncomédica S.A.S","Torregroza Otero, Marco","哥伦比亚","Cordoba","Monteria"],["Sociedad de Oncología Y Hematología del Cesar S.A.S.","Granadillo, Rebeca","哥伦比亚","Cesar","Valledupar."],["Fakultni Nemocnice Ostrava","Kummel, Jan","捷克","Moravskoslezsky kraj","Ostrava - Poruba"],["Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN","Cibula, David","捷克","Praha 2","Praha 2"],["Nemocnice AGEL Novy Jicin a.s.","Tlusty, Vojtech","捷克","Novy Jicin","Novy Jicin"],["Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol","Nohejlova-Medkova, Anna","捷克","Praha 5","Praha 5"],["Fakultni nemocnice Ostrava","Kummel, Jan","捷克","Ostrava mesto","Ostrava"],["Herlev and Gentofte Hospital","Gad, Katrine","丹麦","Hovedstaden","Kobenhavn"],["Aalborg Universitetshospital, Syd","Mapendano, Christophe","丹麦","Nordjylland","Aalborg"],["Roskilde Sygehus","Ujmajuridze, Zaza","丹麦","Sjaelland","Roskilde"],["Aarhus Universitetshospital, Skejby","Kristoffersen, Kristina","丹麦","Midtjylland","Aarhus"],["Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Sy？p？keskus)","Lassus, Heini","芬兰","Uusimaa","Helsinki"],["Turku University Hospital-Department of Obstetrics and Gynecology","Hietanen, Sakari","芬兰","Varsinais-Suomi","Turku"],["Tampereen yliopistollinen sairaala","Auranen, Annika","芬兰","Pirkanmaa","Tampere"],["Kuopion Yliopistollinen Sairaala","Karkkainen, Henna","芬兰","Pohjois-Savo","Kuopio"],["CENTRE LEON BERARD","LE SAUX, Olivia","法国","Rhone","Lyon CEDEX 08"],["CHU Besan？on","Mansi, Laura","法国","Doubs","Besancon"],["Institut De Cancerologie De L Ouest","Frenel, Jean","法国","Loire-Atlantique","Saint-Herblain"],["Hopital Privé Des Cotes d'Armor","Hardy-Bessard, Anne-Claire","法国","Cotes-d Armor","Plerin"],["Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest","Lebreton, Coriolan","法国","Gironde","Bordeaux"],["Centre Hospitalier Universitaire de Poitiers","Emambux, Sheik","法国","Vienne","Poitiers"],["Oncopole Claudius Regaud","Gladieff, Laurence","法国","Haute-Garonne","Toulouse"],["Institut Curie - site Saint-Cloud","Bello Roufai, Diana","法国","Hauts-de-Seine","Saint-Cloud"],["Groupe Hospitalier Diaconesses Croix Saint Simon","Angelergues, Antoine","法国","Paris","Paris"],["Institut Paoli Calmettes","Sabatier, Renaud","法国","Bouches-du-Rhone","MARSEILLE"],["Hopitaux Universitaires Paris Centre-Hopital Cochin","Alexandre, Jerome","法国","Paris","Paris"],["Centre Francois Baclesse","Joly-Lobbedez, Florence","法国","Calvados","Caen"],["CHU Besancon","Wendling, Daniel","法国","Doubs","Besancon"],["Charité Campus Virchow-Klinikum","Braicu, Elena","德国","Berlin","Berlin"],["Universitaetsklinikum Carl Gustav Carus","Wimberger, Pauline","德国","Sachsen","Dresden"],["Universitaetsklinikum Jena","Bauerschlag, Dirk","德国","Thuringen","Jena"],["Universitaetsklinikum Bonn","Mustea, Alexander","德国","Nordrhein-Westfalen","Bonn"],["Universitaetsklinikum Leipzig","Aktas, Bahriye","德国","Sachsen","Leipzig"],["Klinikum Mutterhaus der Borrom？erinnen","Jud, Sebastian","德国","Rheinland-Pfalz","Trier"],["Universitaetsklinikum Aachen","Meyer-Wilmes, Philipp","德国","Nordrhein-Westfalen","Aachen"],["CaritasKlinikum Saarbrücken St. Theresia","Deryal, Mustafa","德国","Saarland","Saarbrücken"],["Asklepios Kliniken Hamburg","Gebauer, Gerhard","德国","Hamburg","Hamburg"],["Klinikum Kassel GmbH","Feisel-Schwickardi, Gabriele","德国","Hessen","Kassel"],["Universit？tsklinikum Münster - Albert Schweitzer Campus","Eltrop, Stephanie","德国","Nordrhein-Westfalen","Muenster"],["Universitaetsklinikum Ulm.","Heublein, Sabine","德国","Baden-Wurttemberg","Ulm"],["Universitaetsklinikum Schleswig-Holstein Campus Kiel","van Mackelenbergh, Marion","德国","Schleswig-Holstein","Kiel"],["Agios Loukas Clinic-DEPARTMENT OF ONCOLOGY","Fountzila, Elena","希腊","Kentriki Makedonia","Thessaloniki"],["Aretaieio Hospital","ZAGOURI, FLORA","希腊","Attiki","Athens"],["ATTIKON GENERAL UNIVERSITY HOSPITAL","Psyrri, Amanda","希腊","Attiki","Chaidari"],["Alexandra General Hospital of Athens","Liontos, Michalis","希腊","Attiki","Athens"],["Iaso Genera","PAPADIMITRIOU, CHRISTOS","希腊","Attiki","Marousi"],["Debreceni Egyetem Klinikai Kozpont-Szülészeti és N？gyógyászati Klinika","Poka, Robert","匈牙利","Debrecen","Debrecen"],["Országos Onkológiai Intézet-Ngyógyászat","Bagameri, Andrea","匈牙利","Budapest","Budapest"],["Semmelweis Egyetem Szuleszeti es Nogyogyaszati Klinika","Mate, Szabolcs","匈牙利","Budapest","Budapest"],["Tata Memorial Hospital","Gupta, Sudeep","印度","Maharashtra","Mumbai"],["All India Institute of Medical Sciences","Pramanik, Raja","印度","Delhi","Delhi"],["HealthCare Global Enterprises Ltd. Hospital","Pai, Vishwajeeth","印度","Karnataka","Bangalore"],["Apollo Hospital","Bajpai, Jyoti","印度","Maharashtra","Mumbai"],["Vardhman Mahavir Medical College and Safdarjung Hospital","Kalra, Kaushal","印度","Delhi","New Delhi"],["Sahyadri Super Speciality Hospital","Kulkarni, Shriniwas","印度","Maharashtra","Mumbai"],["Regional Cancer Centre [M]","Haridas, Lakshmi","印度","Maharashtra","Thiruvananthapuram"],["St. James's Hospital","Cadoo, Karen","爱尔兰","Dublin","Dublin"],["St. Vincent's University Hospital","McSorley, Lynda","爱尔兰","Dublin","Dublin04"],["Cork University Hospital","Collins, Dearbhaile","爱尔兰","Cork","Cork"],["Mater Misericordiae University Hospital","Thompson, Claire","爱尔兰","Dublin","Dublin"],["Shaare Zedek Medical Center","Breuer, Shani","以色列","Jerusalem","Jerusalem"],["Meir Medical Center.","Beiner, Mario","以色列","Kfar Saba","Kfar Saba"],["Sourasky Medical Center","Safra, Tamar","以色列","Tel Aviv","Tel Aviv"],["Carmel Hospital","Segev, Yakir","以色列","Haifa","Haifa"],["Assuta Ashdod Medical Center","Lazarev, Irina","以色列","Ashdod","Ashdod"],["Rambam Health Care Campus","Linder, Revital","以色列","Haifa","Haifa"],["Ospedale Mauriziano","Valabrega, Giorgio","意大利","Torino","Torino"],["Istituto Nazionale Tumori Regina Elena","Savarese, Antonella","意大利","Roma","Roma"],["Ospedale Cannizzaro","Scandurra, Giuseppa","意大利","Catania","Catania"],["Istituto Nazionale Tumori IRCCS Fondazione Pascale","Pisano, Carmela","意大利","Napoli","Napoli"],["Fondazione Policlinico Universitario Agostino Gemelli","Salutari, Vanda","意大利","Roma","Roma"],["Ospedale Humanitas San Pio X","Lorusso, Domenica","意大利","Lombardia","Milan"],["IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST)","Farolfi, Alberto","意大利","Forli-Cesena","Meldola"],["Azienda Ospedaliero Universitaria Pisana Ospedale S. Chiara","Bengala, Carmelo","意大利","Pisa","Pisa"],["Azienda Ospedaliera Universitaria Careggi","petrella, maria cristina","意大利","Firenze","Firenze"],["Istituto Europeo di Oncologia","Caruso, Giuseppe","意大利","Milano","Milano"],["Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino","Piovano, Elisa","意大利","Torino","Torino"],["Ospedale Santa Maria di Ca' Foncello","ARTIOLI, GRAZIA","意大利","Treviso","Treviso"],["Fondazione IRCCS Istituto Nazionale dei Tumori","Raspagliesi, Francesco","意大利","Milano","Milano"],["Saitama Medical University International Medical Center","Hasegawa, Kosei","日本","Saitama","Hidaka"],["Gunma Prefectural Cancer Center","Nakamura, Kazuto","日本","Gunma","Ota"],["National Hospital Organization Kyushu Cancer Center","Ariyoshi, Kazuya","日本","Fukuoka","Fukuoka"],["Kurume University Hospital","Nishio, Shin","日本","Fukuoka","Kurume"],["Shizuoka Cancer Center","Takekuma, Munetaka","日本","Shizuoka","Sunto-gun"],["National Hospital Organization Shikoku Cancer Center","Takehara, Kazuhiro","日本","Ehime","Matsuyama"],["Iwate Medical University Hospital","Baba, Tsukasa","日本","Iwate","Shiwa-gun"],["Cancer Institute Hospital of JFCR","Yunokawa, Mayu","日本","Tokyo","Koto"],["Keio University Hospital","Yamagami, Wataru","日本","Tokyo","Shinjuku"],["Niigata Cancer Center Hospital","Kikuchi, Akira","日本","Niigata","Niigata"],["National Cancer Center Hospital","Sudo, Kazuki","日本","Tokyo","Chuo"],["National Hospital Organization Hokkaido Cancer Center","Minobe, Shinichiro","日本","Hokkaido","Sapporo"],["Ehime University Hospital","Usami, Tomoka","日本","Ehime","Toon"],["National Cancer Center Hospital East","Harano, Kenichi","日本","Chiba","Kashiwa"],["Okayama University Hospital","Nagao, Shoji","日本","Okayama","Okayama"],["Hyogo Cancer Center","Yamamoto, Kasumi","日本","Hyogo","Akashi"],["Aichi Cancer Center","Suzuki, Shiro","日本","Aichi","Nagoya"],["Pantai Hospital Kuala Lumpur","YUSOF, HILAWATI","马来西亚","Kuala Lumpur","Kuala Lumpur"],["Sarawak General Hospital","Ngu, Ming Ruey","马来西亚","Sarawak","Kuching"],["University Malaya Medical Centre","Wan Ishak, Wan Zamaniah","马来西亚","Kuala Lumpur","Kuala Lumpur"],["Hospital Sultan Ismail","Hashim, Nor Hayati","马来西亚","Johor","Johor Bahru"],["Hospital Universitario","ZAYAS VILLANUEVA, OMAR","墨西哥","Nuevo Leon","Monterrey"],["CIO - Centro de Inmuno-Oncología de Occidente","Luna-Romero, Noel Esaul","墨西哥","Jalisco","Guadalajara"],["Higiea Oncologia","Magallanes Maciel, Manuel","墨西哥","Distrito Federal","Ciudad de Mexico"],["Centro de Investigacion Clinica de Oaxaca","Romero Diaz, Roberto","墨西哥","Oaxaca","Oaxaca de Juarez"],["Centro de Investigación Oncológica Galerías SC","Cabrera, Elvis","墨西哥","Aguascalientes","Aguascalientes"],["Operadora Unidad de Investigacion en Salud de Chihuahua SA de CV","Ramirez Medina, Raul","墨西哥","Chihuahua","Chihuahua"],["INCAN","CORONEL, JAIME","墨西哥","Distrito Federal","Ciudad de Mexico"],["Maastricht UMC+","Beijers, Tonneke","荷兰","Limburg","Maastricht"],["UMC St. Radboud","Ottevanger, Petronella","荷兰","Gelderland","Nijmegen"],["Universitair Medisch Centrum Utrecht","Baas, Inge","荷兰","Utrecht","Utrecht"],["Auckland City Hospital","Wilson, Michelle","新西兰","Auckland","Auckland"],["Christchurch Hospital","McLachlan, Jennifer","新西兰","Canterbury","Christchurch"],["Oslo universitetssykehus, Radiumhospitalet","Lindemann, Kristina","挪威","Oslo","Oslo"],["Universitetssykehuset Nord-Norge HF","Ingebrigtsen, Vibeke Anett","挪威","Troms","Tromso"],["Stavanger Universitetssykehus","Nilsen, Elisabeth","挪威","Rogaland","Stavanger"],["Centro Medico Monte Carmelo","Alvarez Barreda, Renzo","秘鲁","Ariqipa","Arequipa"],["Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO)","Ccopa Apaza, Emanuel","秘鲁","Junin","Concepcion"],["IPOR Instituto Peruano de Oncología & Radioterapia","Garcia Rosario, Gustavo","秘鲁","Lima","San Isidro."],["Clínica San Felipe","Li Torres, Walter","秘鲁","Lima","Jesus Maria"],["INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS","Olivera Hurtado de Mendoza, Mivael","秘鲁","Lima","Lima"],["Hospital Cayetano Heredia","Rua Fernandez, Oliver","秘鲁","Lima","Lima"],["Philippine General Hospital","Imperio-Onglao, Romelyn","菲律宾","National Capital Region","Manila"],["Philippine General Hospital","Domingo, Efren","菲律宾","National Capital Region","Manila"],["CARDINAL SANTOS MEDICAL CENTER","Garcia, Christine Joy","菲律宾","National Capital Region","San Juan City"],["Cebu Doctors University Hospital","Uy, Noemi","菲律宾","National Capital Region","Cebu City"],["Philippine General Hospital","Luna, Jericho","菲律宾","National Capital Region","Metro Manila"],["Perpetual Succour Hospital","Sulay, Raymond","菲律宾","Cebu","Cebu City"],["Jose R. Reyes Memorial Medical Center","Cole, Lilli May","菲律宾","National Capital Region","Manila"],["The Medical City","Campos, Ronald Augustine","菲律宾","National Capital Region","Pasig"],["University of the East Ramon Magsaysay Memorial Medical Center","Amparo, Genalin","菲律宾","Quezon","Metro Manila"],["East Avenue Medical Center","Garcia, Stephen Joseph","菲律宾","National Capital Region","Quezon City"],["Makati Medical Center","Domingo, Barbara","菲律宾","National Capital Region","Makati"],["Philippine General Hospital","Manalastas, Ricardo","菲律宾","National Capital Region","Manila"],["St. Paul's Hospital of Iloilo, Inc.","Tupas, Maria Lora","菲律宾","Iloilo","Iloilo City"],["Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi","Klasa-Mazurkiewicz, Dagmara","波兰","Pomorskie","Gdansk"],["Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie","Bidzinski, Mariusz","波兰","Mazowieckie","Warszawa"],["Wielkopolskie Centrum Onkologii im. Marii Sk？odowskiej-Curie","Urbanski, Bartosz","波兰","Wielkopolskie","Poznan"],["Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii","Bodnar, Lubomir","波兰","Mazowieckie","Siedlce"],["Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego","Nowosielski, Krzysztof","波兰","Slaskie","Katowice"],["Narodowy Instytut Onkologii - Oddzial w Gliwicach","Tarnawski, Rafal","波兰","Slaskie","Gliwice"],["Bialostockie Centrum Onkologii","Mackowiak-Matejczyk, Beata","波兰","Podlaskie","Bialystok"],["Swietokrzyskie Centrum Onkologii.","Misiek, Marcin","波兰","Swietokrzyskie","Kielce"],["Centrum Badań Klinicznych JCI","Blecharz, Pawe？","波兰","Malopolskie","Krakow"],["Uniwersytecki Szpital Kliniczny w Poznaniu","Madry, Radoslaw","波兰","Wielkopolskie","Poznań"],["Puerto Rico Cancer Specialists Clinical Trials","Santos-Reyes, Luis","波多黎各","San Juan","San Juan"],["National Cancer Centre Singapore","Chan, Junjie Jack","新加坡","Central Singapore","Singapore"],["National University Hospital","Tan, David","新加坡","Central Singapore","Singapore"],["Severance Hospital, Yonsei University Health System","Nam, EunJi","韩国","Seoul","Seoul"],["Seoul National University Hospital","Kim, Jae-Weon","韩国","Seoul","Seoul"],["Asan Medical Center","Kim, Dae Yeon","韩国","Seoul","Seoul"],["Samsung Medical Center","Lee, Jeong-Won","韩国","Seoul","Seoul"],["Keimyung University Dongsan Hospital","Shin, So Jin","韩国","Taegu-Kwangyokshi","Daegu"],["National Cancer Center","Lim, Myong Cheol","韩国","Kyonggi-do","Gyeonggi-do"],["Hospital Universitari Vall d''Hebron","Farinas Madrid, Lorena","西班牙","Barcelona","Barcelona"],["Hospital Universitario Reina Sofia","Rubio Perez, Maria Jesus","西班牙","Cordoba","Cordoba"],["Hospital Universitario Ramon y Cajal","Guerra Alia, Eva","西班牙","Madrid","Madrid"],["Hospital Universitario 12 de Octubre","Manso Sanchez, Luis","西班牙","Madrid","Madrid"],["Fundación Instituto Valenciano de Oncología","Romero Noguera, Ignacio","西班牙","Valencia","Valencia"],["Hospital Universitario La Paz","Redondo Sanchez, Andres","西班牙","Madrid","Madrid"],["Institut Català d'Oncologia (ICO) - Girona","Barretina Ginesta, Pilar","西班牙","Gerona","Girona"],["CETIR ASCIRES","Pardo Burdalo, Beatriz","西班牙","Barcelona","Barcelona"],["Akademiska Sjukhuset","Koliadi, Anthoula","瑞典","Uppsala lan","Uppsala"],["Skanes Universitetssjukhus Lund","Malander, Susanne","瑞典","Skane lan","Lund"],["National Taiwan University Hospital","Chen, Chi-Hau","中国台湾","台北","台北"],["National Cheng Kung University Hospital","Huang, Yu-Fang","中国台湾","台南","台南"],["Taichung Veterans General Hospital","Lu, Chien-Hsing","中国台湾","台中","台中"],["Mackay Memorial Hospital","Chang, Chih-Long","中国台湾","台北","台北"],["Linkou Chang Gung Memorial Hospital","Lai, Chyong-Huey","中国台湾","桃园","桃园"],["Faculty of Medicine Siriraj Hospital","Jaishuen, Atthapon","泰国","Krung Thep Maha Nakhon","Bangkok"],["Ramathibodi Hospital.","Lertkhachonsuk, Arb-aroon","泰国","Krung Thep Maha Nakhon","Bangkok"],["Faculty of Medicine - Khon Kaen University","Chumworathayi, Bandit","泰国","Khon Kaen","Khon Kaen"],["Maharaj Nakorn Chiang Mai Hospital","Cheewakriangkrai, Chalong","泰国","Chiang Mai","Chiang Mai"],["？ukurova Universitesi T？p Fakültesi Adana Hastanesi","Kara, Ismail Oguz","土耳其","Adana","Sar？sam"],["Koc University, School of Medicine","Taskiran, Cagatay","土耳其","Istanbul","Istanbul"],["Ankara University Cebeci Hospital","Urun, Yuksel","土耳其","Ankara","Ankara"],["Hacettepe Universite Hastaneleri","Arik, Zafer","土耳其","Ankara","Ankara"],["Baskent Universitesi Ankara Hastanesi","OZGUL, Nejat","土耳其","Ankara","Ankara"],["Baskent University Dr. Turgut Noyan Research and Training Center","Kose, Fatih","土耳其","Adana","Adana"],["Istanbul Universitesi Istanbul T？p Fakultesi Hastanesi","Saip, Pinar","土耳其","Istanbul","Istanbul"],["Istanbul Universitesi Cerrahpasa","Bese, Tevfik","土耳其","Istanbul","Fatih"],["Ege Universitesi Hastanesi","Gursoy, Pinar","土耳其","Izmir","Izmir"],["University College London Hospital","Eminowicz, Gemma","英国","London","London"],["Addenbrookes Hospital","Ang, Joo Ern","英国","Cambridgeshire","Cambridge"],["The Christie NHS Foundation Trust","Clamp, Andrew","英国","Manchester","Manchester"],["The Beatson West of Scotland Cancer Centre","Sadozye, Azmat","英国","Glasgow","Glasgow"],["Royal Marsden Hospital (Sutton)","Lalondrelle, Susan","英国","London","Surrey"],["ROYAL MARSDEN HOSPITAL (CHELSEA)","Lalondrelle, Susan","英国","London","Surrey"],["Maidstone Hospital","Kviat, Lorna","英国","United Kingdom","Maidstone"],["Leicester Royal Infirmary","Wood, Joey","英国","Leicester","Leicester"],["James Cook University Hospital","Mansy, Talal","英国","Middlesbrough","Central Middlesbrough"],["Hammersmith Hospital","Tookman, Laura","英国","London","London"],["University Hospitals Sussex NHS Foundation Trust","Herbertson, Rebecca","英国","Brighton and Hove","East Sussex"],["Western General Hospital","Morgan, Jennifer","英国","Midlothian","Edinburgh"],["Washington University School of Medicine","Thaker, Premal","美国","St. Louis","St. Louis"],["AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology","Holloway, Robert","美国","Orlando","Orlando"],["Inova Schar Cancer Institute","Randall, Leslie","美国","Fairfax","Fairfax"],["Laura and Isaac Perlmutter Cancer Center at NYU Langone","Pothuri, Bhavana","美国","New York","New York"],["Willis Knighton Cancer Center","Black, Destin","美国","Shreveport","Shreveport"],["AHN West Penn Hospital","Crafton, Sarah","美国","Pittsburgh","Pittsburgh"],["The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C","Backes, Floor","美国","Columbus","Columbus"],["Parkview Research Center","Menzies, Anya","美国","Fort Wayne","Fort Wayne"],["Yale University School of Medicine","Santin, Alessandro","美国","New Haven","New Haven"],["St. Tammany Parish Hospital","Braly, Patricia","美国","Covington","Covington"],["Holy Name Medical Center","Lewin, Sharyn","美国","Teaneck","Teaneck"],["University of Oklahoma Health Sciences Center, Stephenson Cancer Center","Richardson, Debra","美国","Oklahoma City","Oklahoma City"],["West Cancer Center and Research Institute","Tillmanns, Todd","美国","Germantown","Germantown"],["Miami Valley Hospital South","Guy, Michael","美国","Centerville","Centerville"],["VCU Health Adult Outpatient Pavillion","Salyer, Chelsea","美国","Richmond","Richmond"],["City of Hope","Song, Mihae","美国","Duarte","Duarte"],["Utah Cancer Specialists","Kendall, Stephan","美国","Salt Lake City","Salt Lake City"],["Women & Infants Hospital","Oliver, Matthew","美国","Providence","Providence"],["University of Iowa","Bender, David","美国","Iowa City","Iowa City"],["University of California, Irvine (UCI) Health - UC Irvine Medical Center","Tewari, Krishnansu","美国","Orange","Orange"],["Candler Hospital","Gill, Sarah","美国","Savannah","Savannah"],["Penn State Milton S. Hershey Medical Center","Bruce, Shaina","美国","Hershey","Hershey"],["Hospital of the University of Pennsylvania","Kim, Sarah","美国","Philadelphia","Philadelphia"],["Sidney Kimmel Comprehensive Cancer Center at John Hopkins","Gaillard, Stephanie","美国","Baltimore","Baltimore"],["Washington Hospital Center","Hoskins, Ebony","美国","Washington","Washington"],["University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office","Iglesias, David","美国","Gainesville","Gainesville"],["Optimum Clinical Research Group","Finkelstein, Karen","美国","Albuquerque","Albuquerque"],["John Muir Health Cancer Center","Edraki, Babak","美国","Walnut Creek","Walnut Creek"],["UCSF Medical Center at Mission Bay","Chen, Lee-May","美国","San Francisco","San Francisco"],["Kettering Health Main Campus-Kettering Health Cancer Center","Reid, Thomas","美国","Kettering","Kettering"],["Mount Sinai Cancer Center","Slomovitz, Brian","美国","Miami Beach","Miami Beach"],["Kadlec Clinic Hematology and Oncology","Zhuo, Ying","美国","Kennewick","Kennewick"],["University of South Alabama, Mitchell Cancer Institute","Pierce, Jennifer","美国","Mobile","Mobile"],["Abington Hospital - Asplundh Cancer Center","Edelson, Mitchell","美国","Willow Grove","Willow Grove"],["University of Chicago Medical Center","Kurnit, Katherine","美国","Chicago","Chicago"],["Alaska Women's Cancer Care","Pennington, Kathryn","美国","Anchorage","Anchorage"],["FirstHealth Moore Regional Hospital","Sundborg, Michael","美国","Pinehurst","Pinehurst"],["Rutgers Cancer Institute of New Jersey","Girda, Eugenia","美国","New Brunswick","New Brunswick"],["Hackensack University Medical Center-John Theurer Cancer Center","McNamara, Donna","美国","Hackensack","Hackensack"],["St. Dominic's Hospital","Haygood, Christen","美国","Jackson","Jackson"],["St. Luke's University Health Network","Huepenbecker, Sarah","美国","Bethlehem","Bethlehem"],["MH/MMP GYNONC","Bradford, Leslie","美国","Scarborough","Scarborough"],["Loma Linda University Cancer Center","Ioffe, Yevgeniya","美国","Loma Linda","Loma Linda"],["Swedish Medical Center-Swedish Cancer Institute","Musa, Fernanda","美国","Seattle","Seattle"],["Cedars-Sinai Medical Center","Rimel, Bobbie","美国","Los Angeles","Los Angeles"],["University of New Mexico Comprehensive Cancer Center","Muller, Carolyn","美国","Albuquerque","Albuquerque"],["Oklahoma Cancer Specialists and Research Institute, LLC","Gold, Michael","美国","Tulsa","Tulsa"],["Baylor College of Medicine","Costales, Anthony","美国","Houston","Houston"],["Duke Cancer Institute","Secord, Angeles","美国","Durham","Durham"],["USC Norris Comprehensive Cancer Center","Matsuo, Koji","美国","Los Angeles","Los Angeles"],["Dartmouth-Hitchcock Medical Center","Cass, Ilana","美国","Lebanon","Lebanon"],["Tufts Medical Center","Paraghamian, Sarah","美国","Boston","Boston"],["Memorial Sloan Kettering Cancer Center","Kyi, Chrisann","美国","New York","New York"],["The University of Arizona Cancer Center – North Campus","Miller, Marina","美国","Tucson","Tucson"],["Perlmutter Cancer Center at NYU Langone Hospital – Long Island","Pothuri, Bhavana","美国","Mineola","Mineola"],["Florida Cancer Specialists East","Monk, Bradley","美国","Wellington","Wellington"],["Florida Cancer Specialists - North","Stine, Jessica","美国","St. Petersburg","St. Petersburg"],["Florida Cancer Specialists - South","Guancial, Elizabeth","美国","Fort Myers","Fort Myers"],["Texas Oncology-San Antonio Medical Center","de la Garza, Joseph","美国","San Antonio","San Antonio"],["Texas Oncology - Northeast Texas","Pulaski, Heather","美国","Longview","Longview"],["Minnesota Oncology Hematology, PA","Bollinger, Lauren","美国","Minneapolis","Minneapolis"],["Texas Oncology - DFW","Cloven, Noelle","美国","Fort Worth","Fort Worth"],["Oncology Associates of Oregon, P.C.","Anderson, Charles","美国","Eugene","Eugene"],["Texas Oncology - Gulf Coast","Pustilnik, Terri","美国","Webster","Webster"],["K Hospital - National Cancer Hospital","Le, Thanh Duc","越南","Ha Noi","Ha Noi"],["Ho Chi Minh City Oncology Hospital - Tan Phu Ward","Nguyen, Tuan Khoi","越南","Ho Chi Minh","Ho Chi Minh"],["Hanoi Oncology Hospital","Nguyen, Thi Mai Lan","越南","Ha Noi","Ha Noi"],["Cho Ray Hospital","Le, Tuan Anh","越南","Ho Chi Minh","Ho Chi Minh"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["北京大学人民医院伦理审查委员会","同意","2025-05-15"]]

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: 185 ； 国际: 1123 ；
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；