上海BNT323III期临床试验-评价BNT323在子宫内膜癌患者中的有效性研究

登记号	CTR20252691	试验状态	进行中
申请人联系人	马长福	首次公示信息日期	2025-07-08
申请人名称	映恩生物制药（苏州）有限公司

登记号	CTR20252691
相关登记号	暂无
药物名称	BNT323
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	一项在既往经治HER2表达复发性子宫内膜癌参与者中比较BNT323/DB-1303与研究者选择的化疗方案的随机、多中心、开放性III期试验
试验通俗题目	评价BNT323在子宫内膜癌患者中的有效性研究
试验方案编号	BNT323-01	方案最新版本号	1.0_CHN
版本日期:	2025-01-30	方案是否为联合用药	否

申请人名称	[["映恩生物制药（苏州）有限公司"]]
联系人姓名	马长福	联系人座机	010-67228087	联系人手机号
联系人Email	eason.ma@dualitybiologics.com	联系人邮政地址	北京市-北京市-北京市东城区永定门西滨河路8号中海地产广场东塔1703室	联系人邮编	100077

通过BICR根据实体瘤疗效评价标准（RECIST）第1.1版评估的PFS风险比（HR），比较BNT323与研究者选择的化疗方案在既往接受过ICI治疗的HER2表达复发性子宫内膜癌参与者中的疗效。

试验分类	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	[["成年女性（定义为自愿提供知情同意时年龄≥18岁或当地法规规定的可接受年龄）。"],["患有符合下列条件的经组织学证实的子宫内膜癌：na. 复发性nb. 中心实验室检测确定HER2蛋白表达，HER2 IHC评分为1＋、2＋或3＋，且nc. 未被定义为真正的肉瘤（即平滑肌肉瘤或子宫内膜间质肉瘤）。注：子宫癌肉瘤允许入组。"],["存在RECIST 1.1定义的可测量病灶。"],["美国东部肿瘤协作组（ECOG）体能状态评分为0、1或2。"],["既往接受过至少一线含铂治疗（任何治疗线）。最多允许接受过三线既往治疗。允许既往接受过激素疗法和放疗，不视为既往治疗线。含铂化疗和ICI可以同时给予，也可以作为单独的治疗线。"],["筛选时预期生存期≥12周。"]]
排除标准	[["不符合研究者选择的化疗方案组的所有要求。根据当地处方信息和机构指南，有紫杉醇和多柔比星治疗禁忌症的参与者不能入组本试验。"],["随机化前3个月内有需要住院的小肠梗阻病史。"],["患有可能限制试验要求依从性或显著增高发生不良事件（AE）风险的控制不佳的并发疾病。"],["随机化前2周内存在临床控制不佳的胸腔积液、需要引流的腹水或心包积液，或接受过腹腔分流术或浓缩无细胞腹水再输注疗法。"],["具有需要类固醇治疗的间质性肺疾病（ILD）/非感染性肺炎病史，或当前患有ILD/非感染性肺炎，或筛选时存在影像学检查无法排除的疑似ILD/非感染性肺炎。"],["参与者在试验药物首次给药前14天内使用过免疫抑制药物，但鼻内和吸入性皮质类固醇或剂量低于10 mg/天的全身性皮质类固醇（泼尼松或等效药物）除外。如果在提供知情同意后剂量稳定，则接受皮质类固醇的参与者可继续接受治疗。"],["具有临床意义的肺特异性并发疾病，包括但不限于任何基础肺部疾病（例如，试验随机化前3个月内发生肺栓塞，以及重度哮喘、重度慢性阻塞性肺疾病、限制性肺疾病、肺纤维化、放射性肺炎、明显的胸腔积液等）以及伴肺部受累的任何自身免疫类疾病、结缔组织疾病或炎症性疾病（即，类风湿关节炎、舍格林综合征、肉状瘤病等）和/或既往全肺切除术（完全切除）。"],["随机化前2周内存在控制不佳的感染，需要接受全身性抗生素、抗病毒药或抗真菌药治疗。"],["既往抗癌治疗的毒性尚未恢复，定义为毒性（脱发除外）尚未恢复至≤1级或基线水平。"],["处于妊娠期或哺乳期，或计划在试验期间或试验药物末次给药后7个月内妊娠。"],["对试验药物（试验用药品[IMP]和辅助药品[AxMP]）及其任何辅料或其他单克隆抗体有过敏、超敏反应或不耐受史。"],["既往接受过拓扑异构酶I抑制剂治疗，包括含依沙替康的ADC。"],["随机化前28天内通过超声心动图（ECHO）或多门控采集（MUGA）测量的左心室射血分数（LVEF）＜55%。"]]

试验药	[["中文通用名:BNT323 英文通用名:TrastuzumabPamirtecan 商品名称:/","剂型:注射用冻干粉末 规格:100mg/瓶 用法用量:8mg/kg 用药时程:BNT323将每21天静脉输注一次（即每3周一次[Q3W]），直至出现PD、不可接受的毒性或参与者撤回同意。"]] 序号 名称 用法
对照药	[["中文通用名:多柔比星 英文通用名:Doxorubicin 商品名称:/","剂型:输液用粉末 规格:2mg/ml,100ml/瓶 用法用量:60mg/m2 用药时程:静脉推注或输注每3周给药一次，直至达到最大累积剂量500mg/m2、出现PD、不可接受的毒性或参与者撤回同意。"],["中文通用名:紫杉醇注射液 英文通用名:Paclitaxel 商品名称:/","剂型:输液浓缩液 规格:16.7ml:100mg 用法用量:80mg/m2 用药时程:每个28天周期的第1、8和15天通过静脉输注给药，直至出现PD、不可接受的毒性或参与者撤回同意。"]] 序号 名称 用法

主要终点指标及评价时间	[["接受过 ICI 治疗的子宫内膜癌患者中，BICR评估的PFS","约32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	[["所有HER2表达复发性子宫内膜癌参与者中，BICR评估的PFS","约32个月","有效性指标"],["既往接受过ICI治疗的参与者和所有参与者的总生存期OS","约55个月","有效性指标"],["在既往接受过ICI治疗的参与者和所有参与者中研究者评估的PFS","约32个月","有效性指标"],["在既往接受过ICI治疗的参与者和所有参与者中，BICR评估的ORR和DoR","约55个月","有效性指标"],["比较BNT323与研究者选择的化疗方案的安全n性和耐受性。","约35个月","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	吴小华	学位	医学博士	职称	主任医师
	电话	021-64175590	Email	wuxhgcp@163.com	邮政地址	上海市-上海市-东安路270号
	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","吴小华","中国","上海市","上海市"],["天津市肿瘤医院（天津医科大学肿瘤医院）","王珂","中国","天津市","天津市"],["广西医科大学附属肿瘤医院","张洁清","中国","广西壮族自治区","南宁市"],["中山大学附属第一医院","姚书忠","中国","广东省","广州市"],["济宁医学院附属医院","刘孝伟","中国","山东省","济宁市"],["安徽省立医院","周颖","中国","安徽省","合肥市"],["温州医科大学第一附属医院","赵红琴","中国","浙江省","温州市"],["浙江省肿瘤医院","楼寒梅","中国","浙江省","杭州市"],["山东省肿瘤医院","于浩","中国","山东省","济南市"],["临沂市肿瘤医院","李秀敏","中国","山东省","临沂市"],["厦门大学附属第一医院","陈琼华","中国","福建省","厦门市"],["复旦大学附属妇产科医院","康玉","中国","上海市","上海市"],["西安交通大学第一附属医院","安瑞芳","中国","陕西省","西安市"],["江西省妇幼保健院","梁美蓉","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"],["北京肿瘤医院","郑虹","中国","北京市","北京市"],["湖北省肿瘤医院","黄奕","中国","湖北省","武汉市"],["重庆医科大学附属第二医院","董晓静","中国","重庆市","重庆市"],["中南大学湘雅医院","张瑜","中国","湖南省","长沙市"],["烟台毓璜顶医院","董亮亮","中国","山东省","烟台市"],["甘肃省妇幼保健院","关崇丽","中国","甘肃省","兰州市"],["南京鼓楼医院（南京大学医学院附属鼓楼医院）","朱丽晶","中国","江苏省","南京市"],["汕头大学医学院附属肿瘤医院","周莉","中国","广东省","汕头市"],["襄阳市中心医院","李泉","中国","湖北省","襄阳市"],["吉林大学第一医院","张松灵","中国","吉林省","长春市"],["郑州大学第二医院","王武亮","中国","河南省","郑州市"],["四川省人民医院","李宏敏","中国","四川省","成都市"],["哈尔滨医科大学附属肿瘤医院","陈秀玮","中国","黑龙江省","哈尔滨市"],["中国医科大学附属第一医院","张颐","中国","辽宁省","沈阳市"],["Universitatsklinikum Leipzig Klinik und Poliklinik für Frauenheilkunde","Bahriye Aktas","德国","Sachsen","Leipzig"],["UZA","Sevilay Altintas","比利时","Antwerp","Edegem"],["Willamette Valley Clinical Studies","Charles Anderson","美国","Oregon","EUGENE"],["Mater Hospital Brisbane","Kathryn Middleton","澳大利亚","Queensland","South Brisbane"],["CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST","Joo Ern Ang","英国","Cambridgeshire","Cambridge"],["Kuopio University Hospital","Maarit Anttila","芬兰","Pohjois-Savo","Kuopio"],["Irmandade da Santa Casa de Misericórdia de Porto Alegre","Katsuki Arima Tiscoski","巴西","Rio Grande do Sul","Porto Alegre"],["Ospedale ca Foncello Treviso","Grazia Artioli","意大利","Treviso","Treviso"],["ICO - Site Paul Papin","Paule Augereau","法国","Maine et Loire","Angers Cedex 2"],["Hopital Nord - CHU Marseille","Marjorie Baciuchka-Palmaro","法国","Bouches-du-Rh？ne","Marseille cedex 20"],["CHU de Liège","Christine Gennigens","比利时","Liege","Liege"],["Ohio State University","Floor Backes","美国","Ohio","Columbus"],["Centro de Investigaciones Medicas Mar del Plata","Arturo Barbero","阿根廷","Buenos Aires","Mar del Plata"],["ICO de Girona - H.U. Dr. Josep Trueta","Pilar Barretina","西班牙","Girona","Girona"],["Institut Jules Bordet","Laura Polastro","比利时","Brussels","Anderlecht"],["Hoag Memorial Hospital Presbyterian","Tiffany Beck","美国","California","Newport Beach"],["Sanford Research / USD-Sioux Falls","Maria Bell","美国","South Dakota","Sioux Falls"],["Ospedale San Raffaele","Alice Bergamini","意大利","Milano","Milano"],["ICO - Site René Gauducheau","Dominique Berton Rigaud","法国","Loire Atlantique","Saint Herblain"],["Medipol University Medical Faculty","Ahmet Bilici","土耳其","Istanbul","Istanbul"],["PIB-NIO-Krakow","Pawe？ Blecharz","波兰","Lublin Voivodeship","Siedlce"],["Siedleckie Centrum Onkologii","Lubomir Bodnar","波兰","Lesser Poland Voivodeship","Krakow"],["Erasmus Medisch Centrum","Ingrid Boere","荷兰","South Holland","Rotterdam"],["Uniklinikum Salzburg Landeskrankenhaus","Pia Wolfrum-Ristau","奥地利","Salzburg","Salzburg"],["Hull","George Bozas","英国","East Riding of Yorkshire","Hull"],["Arizona Oncology Associates , PC - HOPE","Joseph Buscema","美国","Arizona","Tucson"],["Hospital Moinhos de Vento","Fernanda Cano Casarotto","巴西","Rio Grande do Sul","Porto Alegre"],["Fundacao Faculdade Regional de Medicina de S？o José do Rio Preto","Camila Ferrari","巴西","Sao Paulo","Sao Jose Rio Preto"],["MacKay Memorial Hospital_ Taipei Branch","Chih-Long Chang","中国台湾","台湾省","台北"],["China Medical University Hospital","Chen-Chang","中国台湾","台湾省","台中"],["National Cancer Centre Singapore","Wen Yee Chay","新加坡","Singapore","Singapore"],["University of California San Francisco (PARENT)","Lee-May Chen","美国","California","San Francisco"],["Keimyung University Dongsan Medical Center","Chi-Heum Cho","韩国","Daegu","Daegu"],["Seuol National University Hospital","Hyun Hoon Chung","韩国","Seoul","Seoul"],["Hospital Universitario Donostia","Maria Cristina Churruca Galaz","西班牙","Guipuzcoa","San Sebastian"],["Klinika gynekologie, porodnictví a neonatologie","David Cibula","捷克","Prague","Praha 2"],["Istituto Europeo di Oncologia","Nicoletta Colombo","意大利","Milano","Milano"],["Hospital Universitario Ramon y Cajal","Alfonso Cortes","西班牙","Madrid","Madrid"],["SUNY Upstate Medical University","Mary Cunningham","美国","New York","Syracuse"],["Clínica Oncostar - Rede D′OR","Vanessa Da Costa Miranda","巴西","Sao Paulo","Sao Paulo"],["Karolinska Institutet, Stockholm","Hanna Dahlstrand","瑞典","Stockholms lan","Solna"],["Oncocare Cancer Centre-Satellite","Sheow Lei Lim","新加坡","Singapore","Singapore"],["Hospital Sao Lucas da PUCRS","Fernanda Damian","巴西","Rio Grande do Sul","Porto Alegre"],["IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori","Alberto Farolfi","意大利","Forli - Cesena","Meldola"],["Fundacao Sao Francisco Xavier","Luciano de Souza Viana","巴西","Minas Gerais","Ipatinga"],["Universitair Ziekenhuis Ghent","Hannelore Denys","比利时","Oost-Vlaanderen","Gent"],["TN Gynecologic Oncology Group, LLC","Stephen DePasquale","美国","Tennessee","Chattanooga"],["Klinkum Kassel","Gabriele Feisel-Schwickardi","德国","Hessen","Kassel"],["Fondazione IRCCS Istituto Nazionale dei Tumori","Monika Ducceschi","意大利","Milano","Milano"],["Institut de Cancérologie de Strasbourg Europe - ICANS","Lauriane Eberst","法国","Bas Rhin","Strasbourg"],["Universitatsklinikum Bonn","Eva-Katharina Egger","德国","Nordrhein Westfalen","Bonn"],["Rabin Medical Centre","Ram Eitan","以色列","Petah Tikva","Petah Tikva"],["H. Clínic i Provincial de Barcelona","Lydia Gaba","西班牙","Barcelona","Barcelona"],["Promedica Flower Hospital","Anjalika Gandhi","美国","Ohio","Slvania"],["Sunshine Hospital, Melbourne, Victoria","Keri-Lee Geneser","澳大利亚","Victoria","St Albans"],["CHU UCL NAMUR site Ste Elisabeth","Stephanie Henry","比利时","Namur","Namur"],["Institut Català d'Oncologia L'Hospitalet","Marta Gil Martin","西班牙","Barcelona","L'Hospitalet de Llobregat"],["Hospital Universitario Virgen Macarena","Maria Del Mar Gordon Santiago","西班牙","Sevilla","Sevilla"],["Department of Clinical Therapeutics, Alexandra Hospital","Michalis Liontos","希腊","Athens","Athens"],["NYU Langone Clinical Cancer Center","Whitfield Growdon","美国","New York","New York"],["Sanford Bismarck Obstetrics and Gynecology-Satellite","Maria Bell","美国","/","/"],["Miami Valley Hospital South","Michael Guy","美国","Ohio","Centerville"],["Sanford Broadway Clinic-Satellite","Maria Bell","美国","/","/"],["Preston","Dennis Yiannakis","英国","Lancashire","Preston"],["Kliniken Essen-Mitte","Philipp Harter","德国","Nordrhein Westfalen","Essen"],["Cliniques Universitaires Saint-Luc","Jean Francois Baurain","比利时","Brussels","Brussels"],["Turku University Hospital","Sakari Hietanen","芬兰","Turku","Turku"],["Bacs-Kiskun Varmegyei Oktatokorhaz","Zsolt Horvath","匈牙利","Bács-Kiskun County","Kecskemet"],["St. Mary's Mercy Medical Center","Ebony Hoskins","美国","District of Columbia","Washington"],["Columbia University Medical Center","June Hou","美国","New York","New York"],["National Cheng Kung University Hospital","Yu-Fang Huang","中国台湾","台湾省","台南"],["Centre Francois Baclesse","Florence Joly","法国","Calvados","Caen Cedex 05"],["Broward Health Medical Center","Scott Jordan","美国","Florida","Ft. Lauderdale"],["Centro Oncologico Riojano Integral (CORI)","Diego Lucas Kaen","阿根廷","La Rioja","La Rioja"],["National Cancer Center","Sokbom Kang","韩国","Gyeonggi-do","Goyang-si"],["Gosford Hospital","Craig Kukard","澳大利亚","New South Wales","Gosford"],["Seoul National University Bundang Hospital","Kim Kidong","韩国","Gyeonggi-do","Seongnam"],["Severance Hospital, Yonsei University Health System","Sang Wun Kim","韩国","Seoul","Seoul"],["FN Ostrava","Jaroslav Klat","捷克","Ostrava-Poruba","Ostrava-Poruba"],["Kuang Tien General Hospital","Victor C. Kok","中国台湾","台湾省","台中"],["Baskent University Adana Hospital","Fatih Kose","土耳其","Adana","Adana"],["Debreceni Egyetem","Zoard Krasznai","匈牙利","Debrecen","Debrecen"],["Wollongong Hospital","Lawrence Kasherman","澳大利亚","New South Wales","Wollongong"],["Hopital Saint-Louis","Tiphaine Lambert","法国","Paris","Cedex 10"],["Jewish Hospital","Susie Lau","加拿大","Quebec","Montreal"],["Gangnam Severance Hospital, Yonsei University Health System","Jae Hoon Kim","韩国","Seoul","Seoul"],["Samsung Medical Center","Jeong-Won Lee","韩国","Seoul","Seoul"],["Odense Universitetshospital","Trine Lembrecht Jorgensen","丹麦","Odense C","Odense C"],["OncoCare Cancer Centre","Sheow Lei Lim","新加坡","Singapore","Singapore"],["Center of Hope","Peter Lim","美国","Nevada","Reno"],["Hospital Sirio-Libanes","Rudinei Linck","巴西","Sao Paulo","Sao Paulo"],["First Department of Medical Oncology, IASO Hospital","Christos Papadimitriou","希腊","Marousi","Marousi"],["Istituto Clinico Humanitas","Domenica Lorusso","意大利","Milano","Milano"],["Taichung Veterans General Hospital","Chien-Hsing Lu","中国台湾","台湾省","台中"],["Zala Varmegyei Szent Rafael Korhaz","Karoly Mahr","匈牙利","Zalaegerszeg","Zalaegerszeg"],["Lund","Susanne Malander","瑞典","Lund","Lund"],["Minnesota Oncology Hematology, P.A.","Adrianne Mallen","美国","Minnesota","Minneapolis"],["Texas Oncology","Dustin Manders","美国","Texas","Dallas"],["CHRU of Besancon - Jean Minjoz Hospital","Laura Mansi","法国","Doubs","Besancon"],["Hospital Universitario 12 de Octubre","Luis Manuel Manso Sanchez","西班牙","Madrid","Madrid"],["Aalborg University Hospital","Christophe Mapendano","丹麦","Alborg","Alborg"],["Semmelweis Egyetem","Szabolcs Mate","匈牙利","Budapest","Budapest"],["USC Norris Comprehensive Cancer Center","Koji Matsuo","美国","California","Los Angeles"],["Virginia Oncology Associates - Hampton","Michael McCollum","美国","Virginia","Norfolk"],["Fakultni Nemocnice Olomouc","Bohuslav Melichar","捷克","Olomouc","Olomouc"],["Adelaide Oncology & Haematology","Ayesha Salim","澳大利亚","South Australia","Adelaide"],["Rigshospitalet, Copenhagen","Trine Jakobi N？ttrup","丹麦","Copenhagen","Copenhagen"],["Florida Cancer Specialists and Research Institute","Bradley Monk","美国","Florida","West Palm Beach"],["University of Colorado","Marisa Moroney","美国","Colorado","Aurora"],["Swedish Cancer Institute","Fernanda Musa","美国","Washington","Seattle"],["IRCCS Oncologico Bari","Emanuele Naglieri","意大利","Bari","Bari"],["UH Coventry & Warwickshire","Walji Nawaz","英国","Warwickshire","Warwick"],["NL Health Services","Joannie Neveu","加拿大","Newfoundland","St. John's"],["Fakultni nemocnice v Motole","Anna Nohejlova Medkova","捷克","Praha 5","Praha 5"],["Orszagos Onkologiai Intezet","Zoltan Novak","匈牙利","Budapest","Budapest"],["H.U. Vall d’Hebron / Barcelona","Ana Oaknin","西班牙","Barcelona","Barcelona"],["Princess Margaret Cancer Centre","Amit Oza","加拿大","Ontario","Toronto"],["University General Hospital","Amanda Psyrri","希腊","Athens","Athens"],["Hospital de Clínicas de Passo Fundo","Julia Pastorello","巴西","Rio Grande do Sul","Passo Fundo"],["Hadassah Medical Center","Tamar Perry","以色列","Jerusalem","Jerusalem"],["Istituto Nazionale Tumori Fondazione G. Pascale","Carmela Pisano","意大利","Napoli","Napoli"],["AZ Groeninge","Philip Debruyne","比利时","West Flanders","Kortrijk"],["Intermountain Medical Center","Emily Prendergast","美国","Utah","Salt Lake"],["Universitatsklinikum Münster","Louisa Proppe","德国","Nordrhein Westfalen","Muenster"],["KALAMATA HOSPITAL","Sofia Stamatopoulou","希腊","Messinia","Kalamata"],["Centro Oncologico de Excelencia","Juan Manuel Puig","阿根廷","San Juan","San Juan"],["Texas Oncology","Heather Pulaski","美国","Texas","Dallas"],["Herlev Hospital","Nicoline Raaschou-Jensen","丹麦","Herlev","Herlev"],["H.U. La Paz / Madrid","Andrés Redondo","西班牙","Madrid","Madrid"],["University of Oklahoma","Debra Richardson","美国","Oklahoma","Oklahoma"],["Clinique Victor Hugo - Centre Jean Bernard","Sophie Roche Forestier","法国","Sarthe","LE MANS"],["Instituto Valenciano de Oncologia IVO","Ignacio Romero Noguera","西班牙","Valencia","Valencia"],["OSF Saint Francis Medical Center","Michelle Rowland","美国","Illinois","Peoria"],["Hospital de Clínicas de Porto Alegre","Pedro Emanuel Rubini Liedke","巴西","Rio Grande do Sul","Porto Alegre"],["H. Reina Sofía / Córdoba","Maria Jesús Rubio","西班牙","Córdoba","Cordoba"],["Hospital Provincial del Centenario","Patricia Saldias","阿根廷","Santa Fe","Rosario"],["Frankston Hospital","Yoland Antill","澳大利亚","Victoria","Frankston"],["Yale University School of Medicine","Alessandro Santin","美国","Connecticut","New Haven"],["University College London Hospitals","Asma Sarwar","英国","Greater London","London"],["Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Vanda Salutari","意大利","Roma","Roma"],["Azienda Ospedaliera Cannizzaro Catania","Giuseppa Scandurra","意大利","Catania","Catania"],["Carmel Medical Center","Yakir Segev","以色列","Haifa","Haifa"],["Sheba MC","Ronnie Shapira-Frommer","以色列","Ramat Gan","Ramat Gan"],["The Catholic University of Korea, Seoul St. Mary’s Hospital","Keun Ho Lee","韩国","Seoul","Seoul"],["Tampere University Hospital","Synnove Staff","芬兰","Tampere","Tampere"],["Edinburgh","Alison Stilie","英国","Lothian Region","Edinburgh"],["LMU Klinikum München - Clinic and Policlinic for Gynecology and Obstetrics","Fabian Trillsch","德国","Bayern","Muenchen"],["Bezmialem Foundation University Dept.of Medical Oncology","Haci Mehmet Turk","土耳其","Istanbul","Istanbul"],["Oulu University Hospital","Elina Urpilainen","芬兰","Oulu","Oulu"],["Ankara University Dept of Obstetrics and Gynecology","Yüksel ürün","土耳其","Ankara","Ankara"],["Ospedale Mauriziano Umberto I","Giorgio Valabrega","意大利","Torino","Torino"],["UZ Leuven","Els Van Nieuwenhuysen","比利时","Leuven","Leuven"],["Hospital Britanico","Karina Vera","阿根廷","Ciudad Autonoma Buenos Aires","Ciudad Autonoma Buenos Aires"],["Taipei Veterans General Hospital","Peng-Hui Wang","中国台湾","台湾省","台北"],["FH Brno","Vit Weinberger","捷克","Brno","Brno"],["Arizona Oncology Associates","Lyndsay Willmott","美国","Arizona","Scottsdale"],["Universitatsklinikum Carl Gustav Carus Dresden","Pauline Wimberger","德国","Sachsen","Dresden"],["Korea University Anam Hospital","Jae Yun Song","韩国","Seoul","Seoul"],["Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS","Claudio Zamagni","意大利","Bologna","Bologna"],["Gynekologicko-porodnická klinika 1. LF UK a Fakultní nemocnice Bulovka","Michal Zikán","捷克","Praha","Praha"],["Asan Medical Center","Kim Yong-Man","韩国","Seoul","Seoul"],["Radboudumc","Petronella Ottevanger","荷兰","Nijmegen","Nijmegen"],["Baskent University Ankara Hospital","Nejat Ozgul","土耳其","Ankara","Ankara"],["Medizinische Universitat Innsbruck","Christian Marth","奥地利","Innsbruck","Innsbruck"],["Cukurova University Medical Faculty","Ganim Khatib","土耳其","Adana","Adana"],["Universitaetsklinikum Tuebingen","Andreas Hartkopf","德国","Baden Wuerttemberg","Tuebingen"],["Royal Cornwall Hospital","John McGrane","英国","Cornwall","Truro"],["Akademiska Sjukhuset","Daria Glaessgen","瑞典","Uppsala","Uppsala"],["Aretaieio Hospital","Flora Zagouri","希腊","Athens","Athens"],["Oslo University Hospital","Kristina Lindemann","挪威","Oslo","Oslo"],["Stavanger University Hospital","Elisabeth Berge Nilsen","挪威","Stavanger","Stavanger"],["Universitaetsklinikum Schleswig-Holstein - Campus Luebeck","Franziska Hemptenmacher","德国","Schleswig Holstein","Luebeck"],["Charité- Universitatsmedizin Berlin","Elena Ioana Braicu","德国","Berlin","Berlin"],["Mount Vernon Hospital","Helen Hockings","英国","Middlesex","Northwood"],["Nottingham University Hospitals City Campus","Shaymaa Hosni","英国","Nottinghamshire","Nottingham"],["Guy's Hospital","Rebecca Kristeleit","英国","Greater London","London"],["Royal Devon and Exeter Hospital (Wonford)","Katherine Scatchard","英国","Devon","Exeter"],["Singleton Hospital","Mau Don Phan","英国","South Glamorgan","Swansea"],["Cancer Research SA","Meena Okera","澳大利亚","South Australia","Adelaide"],["Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie","Beata Mackowiak-Matejczyk","波兰","Bialystok","Bialystok"],["CHA Bundang Medical Center, CHA University","Hyun Park","韩国","Gyeonggi-do","Seongnam-si"],["AULSS 3 Serenissima Presidio Ospedale di Mirano","Alessandra Baldoni","意大利","Milano","Mirano Ve"],["Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital","Ozturk Ates","土耳其","Ankara","Ankara"],["Royal Sussex County Hospital","Rebecca Herbertson","英国","East Sussex","Brighton"],["AKH - Medizinische Universitat Wien","Stephan Polterauer","奥地利","Vienna","Vienna"],["Hacettepe University","Arik Zafer","土耳其","Ankara","Ankara"],["Bristol Haematology and Oncology Centre","Axel Walther","英国","Avon","Bristol"],["Izmir City Hospital","Celal Akdemir","土耳其","Izmir","Izmir"],["FCS South location","Elizabeth Guancial","美国","Florida","Ft. Myers"]]

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","2025-04-07"]]

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: 76 ； 国际: 504 ；
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；