上海注射用GEN1184III期临床试验-一项在铂类药物耐药卵巢癌受试者中比较Rina-S和研究者所选治疗的疗效的研究

登记号	CTR20253987	试验状态	进行中
申请人联系人	聂欣	首次公示信息日期	2025-10-09
申请人名称	普方生物制药（苏州）有限公司

登记号	CTR20253987
相关登记号	CTR20230813
药物名称	注射用GEN1184
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	铂类耐药型卵巢癌患者
试验专业题目	一项在铂耐药卵巢癌患者中比较Rinatabart Sesutecan (Rina-S) 和研究者选择的治疗(IC)的III期、随机、开放标签研究
试验通俗题目	一项在铂类药物耐药卵巢癌受试者中比较Rina-S和研究者所选治疗的疗效的研究
试验方案编号	GCT1184-02（PRO1184-002/GOG-3107/ENGOT-OV86/RAINFOL-02）	方案最新版本号	修正案4_CN-1；v2.0
版本日期:	2025-07-17	方案是否为联合用药	否

申请人名称	[["普方生物制药（苏州）有限公司"]]
联系人姓名	聂欣	联系人座机	021-53099339	联系人手机号	18317058627
联系人Email	xini@genmab.com	联系人邮政地址	江苏省-苏州市-中国（江苏）自由贸易试验区苏州片区新泽路1号生物医药产业园三期A区1号楼101、102单元	联系人邮编	215024

主要目的：①比较接受Rinatabart Sesutecan (Rina-S) 与研究者选择的治疗方案 (IC) 的铂类耐药型卵巢癌 (PROC) 患者的无进展生存期 (PFS)。 次要目的：①在PROC患者中评估Rina-S与IC相比的其他有效性指标；②在PROC患者中比较Rina-S与IC治疗的安全性；③评估QTc中与Rina-S相关的潜在变化；④评估接受Rina-S与IC治疗的患者的患者报告结局。

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	[["参与者必须患有经组织学或细胞学证实的高级别浆液性或子宫内膜样上皮性卵巢癌、原发性腹膜癌或输卵管癌。"],["无论 FRα 表达水平如何，参与者均可入组。"],["参与者必须既往接受过1～4线治疗。"],["参与者必须既往接受过含以下药物的治疗：no 铂类药物化疗no 如果按照机构指南，贝伐珠单抗（或生物类似药）已被列为标准治疗用药且可获取，则需要预先使用贝伐珠单抗进行治疗，除非参与者有明确有记录的禁忌症或出于预防措施方面的考虑或存在不耐受情况no 已知或疑似有害胚系或体系BRCA突变且对铂类化疗达到完全或部分缓解的患者必须接受过多聚ADP-核糖聚合酶（PARP）抑制剂治疗，作为维持治疗，除非参与者没有资格接受PARP抑制剂治疗no Mirvetuximab Soravtansine，前提是：n- Mirvetuximab Soravtansine在入组地区可用，并且n- 基于经FDA批准（或当地等效）的检测确认FRα表达阳性，符合治疗的要求，并且n- 参与者无记录的医学例外情况，包括慢性角膜疾病、角膜移植史或需要持续治疗/监测的活动性眼部疾病，例如未受控制的青光眼、需要玻璃体内注射的湿性年龄相关性黄斑变性、伴有黄斑水肿的活动性糖尿病性视网膜病、黄斑变性、存在视神经乳头水肿和/或单眼视觉。"],["参与者必须患有铂类药物耐药疾病： no 仅接受过1线含铂治疗的患者必须接受过至少4个周期的铂类药物治疗，并且必须达到缓解（完全缓解[CR]或部分缓解[PR]）或在含铂治疗开始时有不可测量的病灶，然后在铂类药物末次给药日期后＞91天至≤183天出现疾病进展。no 接受过2～4线含铂治疗的患者必须在铂类药物末次给药当天或之后183天内出现疾病进展"]]
排除标准	[["既往接受过含拓扑异构酶I抑制剂的抗体-药物偶联物治疗。"],["患有原发性铂类药物难治性疾病，定义为一线含铂治疗方案末次给药后≤91天无缓解（完全缓解(CR)或部分缓解(PR)）或进展的卵巢癌。"],["参与者在研究药物首次给药前3年内有另一种恶性肿瘤病史，或有证据表明既往诊断的恶性肿瘤存在残留病。但是，转移或死亡风险可忽略不计（例如，5年总生存期（OS）≥90%）的肿瘤除外，包括但不限于已得到充分治疗的宫颈原位癌、非黑色素瘤的皮肤癌、导管原位癌或I期子宫癌。"],["已知患有活动性中枢神经系统转移或癌性脑膜炎。此前存在脑转移且接受过治疗的患者可以参加本研究，前提是必须满足以下条件：经治疗后，在本研究入组前脑转移病灶已临床稳定至少4周；参与者无新发或增大的脑转移；在研究药物首次给药前，针对脑转移相关症状的皮质类固醇和抗惊厥药物治疗已停止至少7天。筛选时存在疑似脑转移的患者应在研究入组前接受脑部计算机断层扫描（CT）/磁共振成像（MRI）。"],["在过去91天内曾因胃肠梗阻住院或出现临床症状，或在筛选时有胃肠梗阻的影像学证据。入组前需要肠外营养的患者必须与研究医学顾问进行讨论，以确定其入组资格。"],["需要频繁接受穿刺术（大约每4周一次以上）对症治疗腹水。必须与医学顾问讨论是否入组留置腹腔导管的患者，以确定入组资格。"]]

试验药

[["中文通用名:注射用GEN1184 英文通用名:GEN1184forinjection 商品名称:NA","剂型:注射剂 规格:规格1/瓶 用法用量:基于各周期第1天的评估结果，通过Moesteller公式计算出患者的体表面积(BSA)，并以此进行给药。Rina-S静脉注射剂量为120mg/m2。 用药时程:3周为一个给药周期,直至发生疾病进展、不可接受的毒性、研究者决定停药、患者撤回知情同意、患者妊娠、患者死亡或申办方提前终止研究，以先发生者为准。"]] 序号 名称 用法

对照药

[["中文通用名:紫杉醇注射液 英文通用名:Paclitaxelinjection 商品名称:特素","剂型:注射剂 规格:30mg/瓶 用法用量:将在每4周（Q4W）第1、8和15天以80mg/m2剂量通过IV输注1h进行紫杉醇给药。 用药时程:4周为一个给药周期，直至发生疾病进展、不可接受的毒性、研究者决定停药、患者撤回知情同意、患者妊娠、患者死亡或申办方提前终止研究，以先发生者为准。"],["中文通用名:注射用盐酸托泊替康 英文通用名:TopotecanHydrochlorideforInjection 商品名称:奥罗那","剂型:注射剂 规格:2mg/瓶 用法用量:在Q4W第1、8和15天以4mg/m2剂量通过IV输注30min，或在Q3W第1～5天以1.25mg/m2剂量通过IV输注30min进行托泊替康给药。 用药时程:4周为一个给药周期或3周为一个给药周期，直至发生疾病进展、不可接受的毒性、研究者决定停药、患者撤回知情同意、患者妊娠、患者死亡或申办方提前终止研究，以先发生者为准。"],["中文通用名:盐酸多柔比星脂质体注射液 英文通用名:DoxorubicinHydrochlorideLiposomeInjection 商品名称:里葆多","剂型:注射剂 规格:20mg/瓶 用法用量:将仅在Q4W第1天以40mg/m2剂量通过IV输注1mg/min进行PLD给药；第1周期后，可按1h输注给药。 用药时程:4周为一个给药周期或3周为一个给药周期，直至发生疾病进展、不可接受的毒性、研究者决定停药、患者撤回知情同意、患者妊娠、患者死亡或申办方提前终止研究，以先发生者为准。"],["中文通用名:注射用盐酸吉西他滨 英文通用名:GemcitabineHydrochlorideforInjection 商品名称:健择","剂型:注射剂 规格:200mg/瓶 用法用量:将在Q4W第1、8和15天以1,000mg/m2或800mg/m2（根据研究者的决定）剂量通过IV输注30min进行吉西他滨给药。 用药时程:4周为一个给药周期或3周为一个给药周期，直至发生疾病进展、不可接受的毒性、研究者决定停药、患者撤回知情同意、患者妊娠、患者死亡或申办方提前终止研究，以先发生者为准。"]] 序号 名称 用法

主要终点指标及评价时间

[["无进展生存期(PFS)，由研究者根据实体瘤疗效评价标准（RECIST）第1.1版评估确认","从随机化至研究者根据RECIST第1.1版评估确认首次记录疾病进展（PD）或至全因死亡（以先发生者为准）的时间。临床进展不被视为进展终点。n(最长约5年)","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）","OS定义为从随机化日期直至因任何原因而死亡的日期。n(最长约5年)","有效性指标"],["客观缓解率（ORR），由研究者根据RECIST第1.1版评估确认","首次记录到客观肿瘤缓解（CR或PR）至首次记录到肿瘤进展或全因死亡（以先发生者为准）的时间。n(最长约5年)","有效性指标"],["盲态独立中心阅片 (BICR) 根据RECIST第1.1版确定的PFS和ORR","PFS为从随机化至BICR依RECIST第1.1确认首次PD或全因死亡(以先发生者为准)时间。临床进展不计。ORR为依RECIST 1.1由BICR评估BOR为CR或PR的患者比例。(最长约5年)","有效性指标"],["研究者和BICR根据RECIST第1.1版确定的缓解持续时间（DOR)","DOR定义为从首次记录到客观肿瘤缓解（CR或PR）至首次记录到肿瘤进展或全因死亡（以先发生者为准）的时间。n(最长约5年)","有效性指标"],["根据国际妇癌组织（GCIG）标准评估的CA-125缓解","治疗期间达到GCIG标准规定的CA-125降幅的患者百分比。n(最长约5年)","有效性指标"],["从研究随机化至第2次疾病进展或全因死亡的时间（PFS2）","从随机化至第二次PD（即在后续抗癌治疗或长期随访中报告的第一次PD）或死亡日期的时间。n(最长约5年)","有效性指标"],["治疗期间出现的不良事件（AEs)和实验室检查异常","从研究第1天（给药期间和给药后）至安全性报告周期结束n(最长约5年)","安全性指标"],["心电图（ECG）结果，根据动态心电图","在筛选时，将进行标准12导联ECG安全性评价。n基线至第3周期（周期长度 = 21 天）","安全性指标"],["总体健康状况/生活质量（GHS/Qol）较基线的总体变化","基线，最长约 5 年","安全性指标"],["GHS/Qol评分的至恶化时间（TTD）","最长约 5 年","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、教授、博士研究生导师
	电话	021-64175590-81000	Email	Wu.xh@fudan.edu.cn	邮政地址	上海市-上海市-徐汇区东安路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"],["湖南省肿瘤医院","王静","中国","湖南省","长沙市"],["河南省肿瘤医院","王莉","中国","河南省","郑州市"],["西安交通大学医学院第一附属医院","薛艳","中国","陕西省","西安市"],["中山大学肿瘤防治中心","李俊东","中国","广东省","广州市"],["天津市肿瘤医院","王珂","中国","天津市","天津市"],["四川大学华西第二医院","尹如铁","中国","四川省","成都市"],["辽宁省肿瘤医院","王丹波","中国","辽宁省","沈阳市"],["哈尔滨医科大学附属肿瘤医院","娄阁","中国","黑龙江省","哈尔滨市"],["吉林大学第一医院","张松灵","中国","吉林省","长春市"],["浙江省肿瘤医院","朱滔","中国","浙江省","杭州市"],["福建省肿瘤医院","孙阳","中国","福建省","福州市"],["北京大学肿瘤医院","高雨农","中国","北京市","北京市"],["山东省肿瘤医院","李庆水","中国","山东省","济南市"],["山西省肿瘤医院","孙立新","中国","山西省","太原市"],["复旦大学附属妇产科医院","鹿欣","中国","上海市","上海市"],["重庆大学附属肿瘤医院","黄裕","中国","重庆市","重庆市"],["中国医学科学院北京协和医院","俞梅","中国","北京市","北京市"],["中山大学孙逸仙纪念医院","饶群仙","中国","广东省","广州市"],["南京大学医学院附属鼓楼医院","周怀君","中国","江苏省","南京市"],["Instituto Médico Especializado Alexander Fleming","Giornelli Gomez, Gonzalo","阿根廷","Buenos Aires","Buenos Aires"],["Instituto de Investigaciones Clínicas Cordoba (IICC)","Cortes, Matias","阿根廷","Córdoba","Córdoba"],["Fundacion Medica de Rio Negro y Neuquen","Piazzoni, Luciano","阿根廷","Río Negro","Cipolletti"],["Diagnóstico Médico SA","Baltz Hehn, Natalia","阿根廷","Distrito Federal","Ciudad Autónoma de Buenos Aires (CABA)"],["Hospital Privado - Universitario de Córdoba","ávila, Rodolfo","阿根廷","Córdoba","Córdoba"],["University of Queensland","Shannon, Catherine","澳大利亚","Queensland","South Brisbane"],["Saint John of God - Subiaco Hospital","Meniawy, Tarek","澳大利亚","Western Australia","Subiaco"],["Icon Cancer Centre","Goh, Jeffrey","澳大利亚","Queensland","Chermside"],["Prince of Wales Hospital - Australia","Francis, Katherine","澳大利亚","New South Wales","Randwick"],["Newcastle Private Hospital","Mandaliya, Hiren","澳大利亚","New South Wales","New Lambton Heights"],["Medizinische Universitat Innsbruck","Marth, Christian","奥地利","Tyrol","Innsbruck"],["Medizinische Universitat Wien","Polterauer, Stephan","奥地利","Wien","Wien"],["Ordensklinikum Linz GmbH Barmherzige Schwestern","Lafleur, Judith","奥地利","Oberosterreich","Linz"],["Medizinische Universitat Graz","Trutnovsky, Gerda","奥地利","Styria","Graz"],["Wiener Gesundheitsverbund - Klinik Hietzing","Peters-Engl, Christian","奥地利","Wien","Wien"],["Universitair Ziekenhuis Leuven - Campus Gasthuisberg","Van Gorp, Toon","比利时","Flemish Brabant","Leuven"],["AZORG - Onze-Lieve-Vrouwziekenhuis - Campus Aalst","Huygh, Greet","比利时","Oost-Vlaanderen","Aalst"],["Centre Hospitalier Chretien - Clinique MontLégia","Bourhaba, Maryam","比利时","Liège","Liège"],["Grand Hopital de Charleroi - Notre Dame","Devaux, Alix","比利时","Hainaut","Charleroi"],["Algemeen Ziekenhuis Delta - Campus Rumbeke","De Bock, Marlies","比利时","West-Vlaanderen","Roeselare"],["Algemeen Ziekenhuis Turnhout - Campus Sint-Elisabeth","De Backer, Cleo","比利时","/","Turnhout"],["Centre Hospitalier Universitaire Saint-Pierre","Martinez Mena, Corina","比利时","Bruxelles-Capitale","Brussels"],["OncoStar - Rede D′or","Estevez Diz, Maria Del Pilar","巴西","Sao Paulo","Sao Paulo"],["A Beneficência Portuguesa de Sao Paulo - Unidade Paulista","Zibetti Dal Molin, Graziela","巴西","Sao Paulo","Sao Paulo"],["Hospital das Clinicas da Universidade Federal de Minas Gerais","Nogueira-Rodrigues, Angélica","巴西","Minas Gerais","Belo Horizonte"],["Hospital Nove de Julho - Emergency","Scaranti, Mariana","巴西","Sao Paulo","Sao Paulo"],["Hospital Esperanca - Recife","Silva de Azevedo, Carla","巴西","/","Recife"],["Instituto D'Or de Pesquisa e Ensino - Rio De Janeiro","Paulino, Eduardo","巴西","Rio de Janeiro","Botafogo"],["Catarina Pesquisa Clínica","Borges, Giuliano","巴西","Santa Catarina","Itajaí"],["Hospital Moinhos de Vento","Freitas Rossari, Jose Roberto","巴西","Rio Grande Do Sul","Porto Alegre"],["Instituto Nacional de Cancer José Alencar Gomes da Silva (INCA)","de Melo, Andréia Cristina","巴西","Rio de Janeiro","Rio de Janeiro"],["Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor","Oikawa, Karina","巴西","Sao Paulo","Barretos"],["Liga Contra o Cancer - Centro Avancado de Oncologia","Oliveira, Sulene Cunha Sousa","巴西","Rio Grande do Norte","Natal"],["AMO - Medicina Diagnóstica","Calabrich, Aknar","巴西","Bahia","Salvador"],["Centre Hospitalier de l'Université de Montréal (CHUM)","Provencher, Diane","加拿大","Québec","Montreal"],["Tom Baker Cancer Centre","Ghatage, Prafull","加拿大","Alberta","Calgary"],["Sunnybrook Health Sciences Centre - Bayview Campus","Vicus, Danielle","加拿大","Ontario","Toronto"],["Princess Margaret Cancer Centre","Oza, Amit","加拿大","Ontario","Toronto"],["Vseobecna Fakultni Nemocnice v Praze","Cibula, David","捷克共和国","Prague","Praha 2"],["Fakultní Nemocnice Hradec Králové","Ndukwe, Munachiso","捷克共和国","Hradec Králové","Hradec Králové"],["Masarykuv Onkologicky ústav","Zvaríková, Mária","捷克共和国","Brno","Brno"],["Fakultni nemocnice v Motole","Nohejlová Medková, Anna","捷克共和国","Prague","Praha 5"],["Fakultní Nemocnice Královské Vinohrady","Halaka, Michael","捷克共和国","Prague","Praha 10"],["Fakultni nemocnice Bulovka","Zikan, Michal","捷克共和国","Prague","Praha 8"],["Nemocnice AGEL Novy Jicín a.s.","Tlusty, Vojtch","捷克共和国","Moravian-Silesian","Novy Jicín"],["Odense Universitetshospital","Knudsen, Anja r","丹麦","Syddanmark","Odense"],["Aalborg Universitetshospital","Haslund, Charlotte Aaquist","丹麦","Nordjylland","Aalborg"],["Rigshospitalet","Nottrup, Trine Jakobi","丹麦","Hovedstaden","Copenhagen"],["Gustave Roussy","Ouali, Kaissa","法国","Val-de-Marne","Villejuif"],["Centre Eugène Marquis","de La Motte Rouge, Thibault","法国","Bretagne","Rennes Cedex"],["Institut de Cancérologie de lOuest - Saint-Herblain - Site René Gauducheau","Frenel, Jean-Sebastien","法国","Loire-Atlantique","Saint Herblain"],["Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole","Gladieff, Laurence","法国","Midi-Pyrenees","Toulouse Cedex 9"],["Centre Hospitalier Lyon-Sud","You, Benoit","法国","Rhone-Alpes","Pierre-Bénite"],["Centre Antoine Lacassagne","Follana, Philippe","法国","Provence Alpes Cote D-Azur","Nice Cedex 2"],["Hopital Européen Georges-Pompidou","Gervais, Claire","法国","Ile-de-France","Paris"],["Mammazentrum Hamburg am Krankenhaus Jerusalem","Hilpert, Felix","德国","Hamburg (Hansestadt)","Hamburg"],["Universitatsklinikum Düsseldorf","Fehm, Tanja","德国","Nordrhein-Westfalen","Düsseldorf"],["Universitatsklinikum Carl Gustav Carus Dresden","Wimberger, Pauline","德国","Sachsen","Dresden"],["Universitatsklinikum Heidelberg","Smetanay, Katharina","德国","/","Heidelberg"],["Universitatsklinikum Essen","Thangarajah, Fabinshy","德国","/","Essen"],["Kliniken Essen-Mitte - Evangelische Huyssens-Stiftung","Kaiser, Sabrina","德国","/","Essen"],["Klinikum der Johann Wolfgang Goethe-Universitat","Rost, Maximilian","德国","Hessen","Frankfurt am Main"],["Helios Klinikum Berlin-Buch","Untch, Michael","德国","Berlin","Berlin"],["Universitatsklinikum Münster","Hanker, Lars","德国","Nordrhein-Westfalen","Münster"],["Universitatsklinikum Bonn","Mustea, Alexander","德国","Nordrhein-Westfalen","Bonn"],["Universitatsklinikum des Saarlandes","Radosa, Julia","德国","Saarland","Homburg"],["Universitatsklinikum Gieben und Marburg - Gieben","Meinhold-Heerlein, Ivo","德国","Hessen","Giessen"],["Helios Dr. Horst Schmidt Kliniken Wiesbaden","Eichbaum, Michael","德国","Hessen","Wiesbaden"],["Rotkreuzklinikum München","Polcher, Martin","德国","Bayern","München"],["MVZ Onko Medical GmbH Hanover","Lueck, Hans-Joachim","德国","Niedersachsen","Hannover"],["Saint Luke's Hospital","Fountzila, Elena","希腊","Central Macedonia","Thessaloniki"],["Aretaieio Hospital","Zagouri, Flora","希腊","Attica","Athens"],["University General Hospital Attikon - General Hospital of West Attica H Agia Varvara","Psyrri, Amanda","希腊","Attica","Athens"],["General Hospital of Athens Alexandra","Liontos, Michalis","希腊","Attica","Athens"],["Azienda Ospedaliera Ordine Mauriziano di Torino","Ferrero, Annamaria","意大利","Turin","Torino"],["Ente Ospedaliero Ospedali Galliera","Boitano, Monica","意大利","Genova","Genova"],["Istituto Europeo di Oncologia","Colombo, Nicoletta","意大利","Milan","Milano"],["Fondazione IRCCS - Istituto Nazionale dei Tumori","Raspagliesi, Francesco","意大利","Milan","Milano"],["Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Fagotti, Anna","意大利","Roma","Roma"],["Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele","Bergamini, Alice","意大利","Milan","Milano"],["IRCCS Istituto Nazionale Tumori Regina Elena","Savarese, Antonella","意大利","Rome","Roma"],["Azienda Sanitaria Localedella provincia di Brindisi - Presidio di Brindisi Di Summa - Perrino","Cinieri, Saverio","意大利","Brindisi","Brindisi"],["Azienda Sanitaria Locale di Biella - Nuovo Ospedale degli Infermi","Zavallone, Laura","意大利","Biella","Biella"],["Istituto Oncologico Veneto - IRCCS","Tasca, Giulia","意大利","Padova","Padova"],["Arcispedale Santa Maria Nuova","Bologna, Alessandra","意大利","Reggio Emilia","Reggio Emilia"],["Humanitas San Pio X","Lorusso, Domenica","意大利","Milan","Milano"],["National Cancer Center Hospital East","Harano, Kenichi","日本","Tiba [Chiba]","Kashiwa-shi"],["Ehime University Hospital","Usami, Tomoka","日本","Ehime","Toon-shi"],["The Jikei University Hospital","Okamoto, Aikou","日本","Tokyo","Minato-ku"],["Jichi Medical University Hospital","Fujiwara, Hiroyuki","日本","Totigi [Tochigi]","Shimotsuke-City"],["St. Marianna University Hospital","Suzuki, Nao","日本","Kanagawa","Kawasaki"],["Niigata University Medical and Dental Hospital","Yoshihara, Kosuke","日本","Niigata","Niigata"],["Aichi Cancer Center","Suzuki, Shiro","日本","Aiti [Aichi]","Nagoya"],["Hokkaido Cancer Center","Minobe, Shinichiro","日本","Hokkaido","Sapporo"],["Tohoku University Hospital","Shimada, Muneaki","日本","Miyagi","Sendai"],["Okayama University Hospital","Nagao, Shoji","日本","Okayama","Okayama-Shi"],["Kurume University Hospital","Nishio, Shin","日本","Fukuoka","Kurume-Shi"],["Saitama Medical University - International Medical Center","Hasegawa, Kosei","日本","Saitama","Hidaka-Shi"],["National Cancer Center Hospital","Yonemori, Kan","日本","Tokyo","Tokyo"],["Cancer Institute Hospital of JFCR","Yunokawa, Mayu","日本","Tokyo","Koto"],["Shizuoka Cancer Center","Takahashi, Nobutaka","日本","Sizuoka [Shizuoka]","Sunto-gun"],["Erasmus Medisch Centrum","Boere, Ingrid","荷兰","Zuid-Holland","Rotterdam"],["Leids Universitair Medisch Centrum (LUMC)","Kroep, Judith","荷兰","South Holland","Leiden"],["Amsterdam Universitair Medische Centra - Locatie Academisch Medisch Centrum","Vleugels, Jasper","荷兰","Noord-Holland","Amsterdam"],["Maastricht Universitair Medisch Centrum","Beijers, Antoinetta","荷兰","Limburg","Maastricht"],["Medisch Spectrum Twente - Enschede Koningsplein","Wymenga, Machteld","荷兰","Overijssel","Enschede"],["Oslo Universitetssykehus - Radiumhospitalet","Lindemann, Kristina","挪威","Ostfold","Oslo"],["Universitetssykehuset Nord-Norge - Tromso","Bentzen, Anne Gry","挪威","Troms","Troms"],["Uniwersytecki Szpital Kliniczny w Poznaniu - Augustyna Szamarzewskiego 84","Madry, Radoslaw","波兰","Wielkopolskie","Pozna"],["Uniwersyteckie Centrum Kliniczne w Gdasku","Klasa-Mazurkiewicz, Dagmara","波兰","Pomorskie","Gdask"],["Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie","Chudecka-Gaz, Anita","波兰","Zachodniopomorskie","Szczecin"],["Biaostockie Centrum Onkologii im. Marii Skodowskiej- Curie","Makowiak-Matejczyk, Beata","波兰","Podlaskie","Biaystok"],["Mazowiecki Szpital Wojewódzki im. w. Jana Pawa II w Siedlcach","Bodnar, Lubomir","波兰","Mazowieckie","Siedlce"],["Instytut Centrum Zdrowia Matki Polki","Kalinka, Ewa","波兰","Lódzkie","ód"],["Jagielloskie Centrum Innowacj","Blecharz, Pawe","波兰","Malopolskie","Kraków"],["Narodowy Instytut Onkologii im. Marii Skodowskiej-Curie - Pastwowy Instytut Badawczy","Bidziski, Mariusz","波兰","Mazowieckie","Warszawa"],["Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie","Urbaski, Bartosz","波兰","Wielkopolskie","Pozna"],["Severance Hospital","Kim, Sangwun","韩国","Seoul Teugbyeolsi [Seoul-T'ukpyolshi]","Seoul"],["The Catholic University of Korea - Seoul St. Mary's Hospital","Lee, Keun Ho","韩国","Seoul Teugbyeolsi [Seoul-T'ukpyolshi]","Seoul"],["Samsung Medical Center","Lee, Jeong-Won","韩国","Seoul Teugbyeolsi [Seoul-T'ukpyolshi]","Seoul"],["Korea Institute of Radiological and Medical Sciences","Kim, Moon-Hong","韩国","Seoul Teugbyeolsi [Seoul-T'ukpyolshi]","Seoul"],["Korea University Anam Hospital","Song, Jaeyun","韩国","Seoul Teugbyeolsi [Seoul-T'ukpyolshi]","Seoul"],["Gangnam Severance Hospital","Kim, Jae-Hoon","韩国","Seoul Teugbyeolsi [Seoul-T'ukpyolshi]","Seoul"],["Seoul National University Hospital","Kim, Hee Seung","韩国","Seoul Teugbyeolsi","Seoul"],["Complejo Hospitalario Universitario A Coruna","Quindos Varela, Maria","西班牙","La Coruna","A Coruna"],["Hospital Universitario La Paz","Redondo, Andres","西班牙","Madrid","Madrid"],["IVO - Fundacion Instituto Valenciano de Oncologia","Romero Noguera, Ignacio","西班牙","València","València"],["Hospital Universitario Donostia","Churruca, Cristina","西班牙","Gipuzkoa","Donostia-San Sebastián"],["Hospital Universitario Virgen del Rocío","Estevez Garcia, Purificacion","西班牙","Sevilla","Sevilla"],["Hospital Clínico Universitario Virgen de la Arrixaca","Puertes Boix, Ana","西班牙","Murcia","Murcia"],["Hospital Universitario Miguel Servet","Ortega Izquierdo, Eugenia","西班牙","Zaragoza","Zaragoza"],["MD Anderson Cancer Center Madrid","Márquez Vázquez, Raul","西班牙","Madrid","Madrid"],["The Royal Marsden NHS Foundation Trust","Banerjee, Susana","英国","England","London"],["Guy's and St Thomas' NHS Foundation Trust","Kristeleit, Rebecca","英国","England","London"],["The Christie NHS Foundation Trust","Clamp, Andrew","英国","England","Manchester"],["Gloucestershire Hospitals NHS Foundation Trust","Cook, Audrey","英国","England","Gloucestershire"],["Leeds Teaching Hospitals NHS Trust","Jackson, David P.","英国","England","Leeds"],["The Clatterbridge Cancer Centre NHS Foundation Trust","Cossar, Laura","英国","England","Wirral"],["Women's Cancer Associates (St Petersburg)","Indermaur, Megan","美国","Florida","St. Petersburg"],["Arizona Center for Cancer Care (ACCC) - Biltmore","Willmott, Lyndsay","美国","Arizona","Phoenix"],["Jefferson Health - Asplundh Cancer Pavilion","Edelson, Mitchell","美国","Pennsylvania","Willow Grove"],["Intermountain Health - Intermountain Medical Center","Prendergast, Emily","美国","Utah","Murray"],["University Hospital Simmons Cancer Center at UT Southwestern Medical Center at Richardson/Plano","Lea, Jayanthi","美国","Texas","Richardson"],["UT Southwestern Harold C. Simmons Comprehensive Cancer Center at Moncrief Cancer Institute - Forth Worth","Lea, Jayanthi","美国","Texas","Fort Worth"],["Parkland Health & Hospital System","Lea, Jayanthi","美国","Texas","Dallas"],["Women's Cancer Associates - Tampa","Indermaur, Megan","美国","Florida","Tampa"],["James P. Wilmot Cancer Center","Moore, Richard G.","美国","New York","Rochester"],["University of Michigan","Siedel, Jean","美国","Michigan","Ann Arbor"],["Fred Hutchinson Cancer Research Center","Gray, Heidi","美国","Washington","Seattle"],["Thomas Jefferson University - Center City","Edelson, Mitchell","美国","Pennsylvania","Philadelphia"],["Jefferson Health Medical Oncology","Edelson, Mitchell","美国","New Jersey","Sewell"],["University of Colorado Health - Highlands Ranch Hospital","Brubaker, Lindsay","美国","Colorado","Aurora"],["Beth Israel Deaconess Medical Center","Shea, Meghan","美国","Massachusetts","Boston"],["Mount Sinai Comprehensive Cancer Center","Slomovitz, Brian","美国","Florida","Miami Beach"],["University of Texas Southwestern Medical Center","Lea, Jayanthi","美国","Texas","Dallas"],["Augusta University Georgia Cancer Center","Ghamande, Sharad","美国","Georgia","Augusta"],["Holy Cross Health - Holy Cross Hospital","Aylesworth, Cheryl","美国","Maryland","Silver Spring"],["Oregon Health and Science University","Munro, Elizabeth","美国","Oregon","Portland"],["Kadlec Clinic - Hematology and Oncology","Zhuo, Ying","美国","Washington","Kennewick"],["University of Cincinnati Medical Center","Herzog, Thomas","美国","Ohio","Cincinnati"],["University of Kansas Cancer Center - Westwood/Richard and Annette Bloch Cancer Care Pavilion","Jewell, Andrea","美国","Kansas","Kansas City"],["New York-Presbyterian - Weill Cornell Medical Center","Cantillo, Evelyn","美国","New York","New York"],["Louisiana State University Health Sciences Center (LSU Health) - New Orleans","Castellano, Tara","美国","Louisiana","New Orleans"],["Yale School of Medicine","Santin, Alessandro","美国","Connecticut","New Haven"],["UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center","Brubaker, Lindsay","美国","Colorado","Aurora"],["University of Texas Health Science Center at Houston (UT Health)","Lucci III, Joseph","美国","Texas","Houston"],["NewYork-Presbyterian Brooklyn Methodist Hospital","Cantillo, Evelyn","美国","New York","Brooklyn"],["St. Luke's University Health Network","Taylor, Nicholas","美国","Pennsylvania","Bethlehem"],["Roswell Park Comprehensive Cancer Center","Zsiros, Emese","美国","New York","Buffalo"],["Allegheny Health Network - West Penn Hospital","Crafton, Sarah","美国","Pennsylvania","Pittsburgh"],["Northside Hospital Atlanta","Tenney, Meaghan","美国","Georgia","Atlanta"],["Barbara Ann Karmanos Cancer Institute","Morris, Robert","美国","Michigan","Detroit"],["Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center","Pearre, Diana","美国","California","Burbank"],["University of Arizona Cancer Center - Research and Administration at Main Campus","Chambers, Setsuko","美国","Arizona","Tucson"],["University of Wisconsin - Madison","Sobecki, Janelle","美国","Wisconsin","Madison"],["Fox Chase Cancer Center","Jain, Angela","美国","Pennsylvania","Philadelphia"],["Herbert Irving Comprehensive Cancer Center","Wright, Jason","美国","New York","New York"],["Kaiser Permanente - Vallejo Medical Center","Kavecansky, Juraj","美国","California","Vallejo"],["MetroHealth Medical Center","Resnick, Kimberly","美国","Ohio","Cleveland"],["HCA Midwest Health","LyBarger, Kristopher Shawn","美国","Missouri","Kansas City"],["SCRI Oncology Partners","Spigel, David","美国","Tennessee","Nashville"],["SCRI - Florida Cancer Specialists - West Palm Beach","Monk, Bradley","美国","Florida","West Palm Beach"],["West Virginia University Cancer Institute","Pfaendler, Krista","美国","West Virginia","Morgantown"],["SCRI - Florida Cancer Specialists - South Region Research Office","Guancial, Elizabeth","美国","Florida","Fort Myers"],["Norwalk Hospital","Zahrah, George","美国","Connecticut","Norwalk"],["Corewell Health (Spectrum Health)","Gressel, Gregory","美国","Michigan","Grand Rapids"],["Legacy Meridian Park Medical Center","Fehniger, Julia","美国","Oregon","Tualatin"],["Legacy Salmon Creek Medical Center","Fehniger, Julia","美国","Washington","Vancouver"],["Baptist Health Lexington","Cottrill, Hope","美国","Kentucky","Lexington"],["USOR - Virginia Oncology Associates - Norfolk","McCollum, Michael","美国","Virginia","Norfolk"],["Inova Schar Cancer Institute","Randall, Leslie","美国","Virginia","Fairfax"],["SCRI - HCA Midwest Health - Menorah Medical Center","LyBarger, Kristopher Shawn","美国","Missouri","Kansas City"],["Sarah Cannon at Centerpoint Medical Center","LyBarger, Kristopher Shawn","美国","Missouri","Kansas City"],["Maine Medical Center Cancer Institute- Scarborough","Bradford, Leslie","美国","Maine","Scarborough"],["Sarasota Memorial Research Institute","Long, Beverly","美国","Florida","Sarasota"],["First Physician's Group of Sarasota Memorial Health Care System","Long, Beverly","美国","Florida","Sarasota"],["SCRI - Florida Cancer Specialists - Venice Pinebrook","Long, Beverly","美国","Florida","Venice"],["SCRI - Florida Cancer Specialists - Sarasota Downtown","Long, Beverly","美国","Florida","Sarasota"],["Sarasota Memorial Hospital - Venice Campus","Long, Beverly","美国","Florida","North Venice"],["Dana-Farber Cancer Institute","Lee, Elizabeth","美国","Massachusetts","Boston"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center Blood and Marrow Transplant","Cloven, Noelle","美国","Texas","Dallas"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Bedford","Cloven, Noelle","美国","Texas","Bedford"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Presbyterian Cancer Center Dallas","Cloven, Noelle","美国","Texas","Dallas"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Methodist Charlton Cancer Center","Cloven, Noelle","美国","Texas","Dallas"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Arlington Cancer Center North","Cloven, Noelle","美国","Texas","Arlington"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Methodist Charlton Cancer Center","Cloven, Noelle","美国","Texas","Dallas"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Harlingen","Knowles, Lynne","美国","Texas","Harlingen"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Waco","Knowles, Lynne","美国","Texas","Waco"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Weslaco","Knowles, Lynne","美国","Texas","Weslaco"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - South Austin","Knowles, Lynne","美国","Texas","Austin"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Horizon Circle","Knowles, Lynne","美国","Texas","Waco"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - El Paso Gateway","Melnyk, Jr., Anton","美国","Texas","El Paso"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Midland Allison Cancer Center","Melnyk, Jr., Anton","美国","Texas","Midland"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Odessa West Texas Cancer Center","Melnyk, Jr., Anton","美国","Texas","Odessa"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Wichita Falls Cancer Center","Melnyk, Jr., Anton","美国","Texas","Wichita Falls"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - El Paso Joe Battle","Melnyk, Jr., Anton","美国","Texas","El Paso"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Amarillo Cancer Center","Melnyk, Jr., Anton","美国","Texas","Amarillo"],["Cleveland Clinic - Fairview Hospital","Michener, Chad","美国","Ohio","Cleveland"],["Cleveland Clinic - Hillcrest Hospital","Michener, Chad","美国","Ohio","Mayfield Heights"],["Duke Women's Cancer Care Raleigh","Secord, Angeles","美国","North Carolina","Durham"],["Northwest Cancer Specialists, P.C. dba Compass Oncology - West Cancer Center","Winter III, William","美国","Oregon","Portland"],["Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center","Winter III, William","美国","Oregon","Portland"],["USOR - Virginia Oncology Associates - Newport News","McCollum, Michael","美国","Virginia","Norfolk"],["USOR - Virginia Oncology Associates - Chesapeake","McCollum, Michael","美国","Virginia","Norfolk"],["Perlmutter Cancer Center at NYU Langone Hospital - Long Island","Pothuri, Bhavana","美国","New York","New York"],["University Hospitals Geauga Medical Center","Lynam, Sarah","美国","Ohio","Chardon"],["University Hospitals Seidman Cancer Center at St John's Medical Center","Lynam, Sarah","美国","Ohio","Westlake"],["Lake Health/University Hospitals Seidman Cancer Center at Mentor Health Center","Lynam, Sarah","美国","Ohio","Mentor"],["University Hospitals Minoff Health Center at Chagrin Highlands","Lynam, Sarah","美国","Ohio","Orange Village"],["Nuvance Health","Zahrah, George","美国","Connecticut","Danbury"],["Trinity Health Medical Center - Brighton","Liu, Janice (J. Rebecca)","美国","Michigan","Brighton"],["Trinity Health Medical Center - Canton","Liu, Janice (J. Rebecca)","美国","Michigan","Canton"],["Trinity Health - Chelsea Hospital","Liu, Janice (J. Rebecca)","美国","Michigan","Chelsea"],["Trinity Health - Livonia Hospital","Liu, Janice (J. Rebecca)","美国","Michigan","Livonia"],["Texas Oncology - Austin Central","Knowles, Lynne","美国","Texas","Austin"],["Emory University Hospital Midtown","Manning-Geist, Beryl","美国","Georgia","Atlanta"],["Emory Saint Joseph's Hospital","Manning-Geist, Beryl","美国","Georgia","Atlanta"],["Grady Health System - Correll Pavilion","Manning-Geist, Beryl","美国","Georgia","Atlanta"],["Kaiser Permanente - Oakland Medical Center","Kavecansky, Juraj","美国","California","Oakland"],["Kaiser Permanente - Walnut Creek Medical Center","Kavecansky, Juraj","美国","California","Walnut Creek"],["Kaiser Permanente - San Francisco Medical Center","Kavecansky, Juraj","美国","California","San Francisco"],["Kaiser Permanente - Santa Clara Medical Center","Kavecansky, Juraj","美国","California","Santa Clara"],["Kaiser Permanente - Roseville Medical Center","Kavecansky, Juraj","美国","California","Roseville"],["JamesCare Gynecologic Oncology at Mill Run","Backes, Floor","美国","Ohio","Hilliard"],["UCSF Helen Diller Family Comprehensive Cancer Center","Alvarez, Edwin","美国","California","San Francisco"],["University of New Mexico Comprehensive Cancer Center","Muller, Carolyn","美国","New Mexico","Albuquerque"],["Cleveland Clinic Main Campus","Michener, Chad","美国","Ohio","Cleveland"],["The Center of Hope - Reno","Lim, Peter","美国","Nevada","Reno"],["Legacy Good Samaritan Medical Center","Fehniger, Julia","美国","Oregon","Portland"],["University of California San Diego Moores Cancer Center","Eskander, Ramez","美国","California","La Jolla"],["Sarasota Memorial Hospital","Long, Beverly","美国","Florida","Sarasota"],["Avera Cancer Institute","Starks, David","美国","South Dakota","Sioux Falls"],["Saint Joseph Mercy Ann Arbor Hospital","Liu, Janice (J. Rebecca)","美国","Michigan","Ypsilanti"],["St. Elizabeth Healthcare - Edgewood","Bramblet, Rachel","美国","Kentucky","Edgewood"],["FirstHealth Outpatient Cancer Center","Sundborg, Michael","美国","North Carolina","Pinehurst"],["Holy Name Medical Center","Lewin, Sharyn","美国","New Jersey","Teaneck"],["Winship Cancer Institute of Emory University - Clifton Campus","Manning-Geist, Beryl","美国","Georgia","Atlanta"],["Gynecologic Oncology Associates - Shreveport","Black, Destin","美国","Louisiana","Shreveport"],["Universidad de Puerto Rico - Centro Comprensivo de Cáncer","Santos Reyes, Luis","美国","/","San Juan"],["USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center","Winter III, William","美国","Oregon","Portland"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central","Knowles, Lynne","美国","Texas","Austin"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth","Cloven, Noelle","美国","Texas","Fort Worth"],["USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene","Melnyk, Jr., Anton","美国","Texas","Abilene"],["Northwest Cancer Center - Dyer","Singh, Shruti","美国","Indiana","Dyer"],["Duke Cancer Institute","Secord, Angeles","美国","North Carolina","Durham"],["Perlmutter Cancer Center - 38th Street","Pothuri, Bhavana","美国","New York","New York"],["Hartford Hospital","Brown, Amy K.","美国","Connecticut","Hartford"],["University Hospitals Cleveland Medical Center","Lynam, Sarah","美国","Ohio","Cleveland"],["Alaska Women's Cancer Care","Pennington, Kathryn","美国","Alaska","Anchorage"],["University of Nebraska Medical Center","McAlarnen, Lindsey","美国","Nebraska","Omaha"],["Orlando Health Cancer Institute - Downtown Orlando","Seward, Shelly","美国","Florida","Orlando"],["Penn State Health Milton S. Hershey Medical Center","Shaina, Bruce","美国","Pennsylvania","Hershey"],["Providence Sacred Heart Medical Center","Bergman, Melanie","美国","Washington","Spokane"]]

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","修改后同意","2024-10-08"],["复旦大学附属肿瘤医院医学伦理委员会","同意","2024-10-28"],["复旦大学附属肿瘤医院医学伦理委员会","同意","2025-04-28"],["复旦大学附属肿瘤医院医学伦理委员会","同意","2025-06-18"],["复旦大学附属肿瘤医院医学伦理委员会","同意","2025-09-02"]]

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: 88 ； 国际: 530 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 77 ；
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：2025-02-07；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2025-02-17；
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；