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更新时间:   2026-04-03

上海注射用MK-2870III期临床试验-芦康沙妥珠单抗对比研究者选择的非铂类化疗治疗晚期经治膀胱癌患者的Ⅲ期研究

上海复旦大学附属肿瘤医院开展的注射用MK-2870III期临床试验信息,需要患者受试者,主要适应症为尿路上皮癌
  上一个试验     目前是第 21982 个试验/共 21988 个试验     下一个试验  
登记号 CTR20261273 试验状态 进行中
申请人联系人 杨双 首次公示信息日期 2026-04-03
申请人名称 默沙东研发(中国)有限公司
一、题目和背景信息
登记号 CTR20261273
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 尿路上皮癌
试验专业题目 一项在既往经治的局部晚期/转移性尿路上皮癌受试者中对比芦康沙妥珠单抗(MK-2870)与研究者选择的非铂类化疗的III期、随机、开放标签研究
试验通俗题目 芦康沙妥珠单抗对比研究者选择的非铂类化疗治疗晚期经治膀胱癌患者的Ⅲ期研究
试验方案编号 MK-2870-031 方案最新版本号 00
版本日期: 2025-10-29 方案是否为联合用药
二、申请人信息
申请人名称 [["默沙东研发(中国)有限公司"]]
联系人姓名 杨双 联系人座机 020-38163955 联系人手机号 18520142856
联系人Email shuang.yang3@msd.com 联系人邮政地址 广东省-广州市-天河区珠江东路6号,K11周大福金融中心13层 联系人邮编 510000
三、临床试验信息
1、试验目的
比较芦康沙妥珠单抗与研究者选择的非铂类化疗的OS
2、试验设计
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
3、受试者信息
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
入选标准 [["经组织学确诊为局部晚期/转移性尿路上皮癌"],["有由研究者根据RECIST 1.1评估的可测量病灶"],["接受过抗PD-(L)1治疗、含铂化疗和EV(和/或DV)治疗"],["在进入研究前的最近一线治疗期间或之后发生影像学疾病进展"],["随机分组前7天内ECOG体能状态为0或1分"],["可获得存档肿瘤组织样本或新采集的既往未接受过放疗的肿瘤病灶活检样本,并将提交该样本"],["有HIV感染的受试者必须在ART治疗后HIV得到良好控制"],["HBsAg阳性的受试者在治疗分配前已接受至少4周的HBV抗病毒治疗并且HBV病毒载量检测不到"],["有HCV感染史的受试者筛选时应检测不到HCV病毒载量"],["因既往抗肿瘤治疗而发生AE的受试者必须已恢复至≤1级或基线水平"],["具有充分的器官功能"]]
排除标准 [["重度干眼症、重度睑板腺疾病和/或睑缘炎或妨碍/延缓角膜愈合的重度角膜疾病的病史"],["在研究干预给药前6个月内患有未控制的重大心血管疾病或脑血管疾病"],["有需要类固醇治疗的(非感染性)肺部炎症/间质性肺疾病病史或当前患有肺部炎症/间质性肺疾病。"],["有卡波西肉瘤和/或多中心型Castleman病病史的HIV感染者"],["随机分组前4周或5个半衰期(以较短者为准)内接受过既往系统性抗肿瘤治疗"],["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"],["既往接受过含MMAE抑制剂的ADC(EV和DV除外)治疗"],["在研究干预开始前6周内完成既往外照射治疗或在4周内完成立体定向放疗,或存在需要皮质类固醇治疗的放疗相关毒性"],["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"],["目前正在接受强效CYP3A4诱导剂/抑制剂治疗,且在研究期间无法停用"],["既往针对尿路上皮癌接受过对照组任何研究药物"],["已知患有或在过去3年内需要积极治疗的其他恶性肿瘤"],["被诊断为免疫缺陷性疾病"],["当前或既往存在CNS转移和/或癌性脑膜炎"],["对研究干预或其任何辅料有重度超敏反应(≥3级)"],["研究者认为,既往或当前存在任何可能混淆研究结果或干扰受试者配合研究要求的能力的状况、治疗、实验室检查异常或其他情况"],["干细胞/实体器官移植史"]]
4、试验分组
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:160mg/瓶,200mg/瓶
用法用量:4mg/kg静脉输注,每2周一次,输注的持续时间约90min
用药时程:持续至符合任何终止研究干预的标准"]]
序号 名称 用法
对照药 [["中文通用名:多西他赛注射液
英文通用名:Docetaxelinjection
商品名称:泰素帝","剂型:注射剂
规格:0.5ml:20mg
用法用量:75mg/m2静脉输注,每三周一次
用药时程:持续至符合任何终止研究干预的标准"],["中文通用名:紫杉醇注射液
英文通用名:PaclitaxelInjection
商品名称:泰素Taxol","剂型:注射剂
规格:5ml:30mg
用法用量:175mg/m2静脉输注,每三周一次
用药时程:持续至符合任何终止研究干预的标准"],["中文通用名:紫杉醇注射液
英文通用名:PaclitaxelInjection
商品名称:安素泰","剂型:注射剂
规格:5ml:30mg
用法用量:175mg/m2静脉输注,每三周一次
用药时程:持续至符合任何终止研究干预的标准"]]
序号 名称 用法
5、终点指标
主要终点指标及评价时间 [["总生存期(OS)","方案规定的分析时间","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 [["研究者根据RECIST 1.1评估的无进展生存期(PFS)","方案规定的分析时间","有效性指标"],["研究者根据RECIST 1.1评估的ORR","方案规定的分析时间","有效性指标"],["研究者根据RECIST 1.1评估的DOR","方案规定的分析时间","有效性指标"],["EORTC QLQ-C30中HRQoL和疾病相关症状较基线的变化","方案规定的分析时间","有效性指标+安全性指标"]]
序号 指标 评价时间 终点指标选择
四、研究者信息
1、主要研究者信息
1 姓名 叶定伟 学位 博士 职称 主任医师
电话 021-64175590-1805 Email dwyeli@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
2、各参加机构信息
[["复旦大学附属肿瘤医院","叶定伟","中国","上海市","上海市"],["湖南省肿瘤医院","蒋书算","中国","湖南省","长沙市"],["中山大学肿瘤防治中心","史艳侠","中国","广东省","广州市"],["北京大学第一医院","龚侃","中国","北京市","北京市"],["四川大学华西医院","张双","中国","四川省","成都市"],["南京鼓楼","郭宏骞","中国","江苏省","南京市"],["中山大学肿瘤防治中心","刘卓炜","中国","广东省","广州市"],["中山大学孙逸仙纪念医院","黄健","中国","广东省","广州市"],["江西省肿瘤医院","涂新华","中国","江西省","南昌市"],["宁波市第一医院","蒋军辉","中国","浙江省","宁波市"],["温州医科大学附属第一医院","黄航","中国","浙江省","温州市"],["重庆医科大学附属第一医院","何卫阳","中国","重庆市","重庆市"],["华中科技大学同济医学院附属协和医院","章小平","中国","湖北省","武汉市"],["南方医科大学珠江医院","徐啊白","中国","广东省","广州市"],["中山大学附属第五医院","戴英波","中国","广东省","珠海市"],["嘉兴市第一医院","何屹","中国","浙江省","嘉兴市"],["复旦大学附属中山医院","郭剑明","中国","上海市","上海市"],["天津医科大学第二医院","胡海龙","中国","天津市","天津市"],["中南大学湘雅二医院","王晶晶","中国","湖南省","长沙市"],["江苏省肿瘤医院","徐子程","中国","江苏省","南京市"],["AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc","Sonpavde, Guru","美国","Florida","Orlando"],["Asociacion de Beneficencia Hospital Sirio Libanes","Cutuli, Hernan","阿根廷","Buenos Aires (CABA)","Ciudad Autonoma De Buenos Aires"],["Athens Medical Center","Tsiatas, Marinos","希腊","Attica","Marousi"],["AZ Maria Middelares","Vulsteke, Christof","比利时","Oost-Vlaanderen","Gent"],["Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli","Scagliarini, Sarah","意大利","Campania","Naples"],["Azienda Ospedaliera S. Luigi Gonzaga","Buttigliero, Consuelo","意大利","Piemonte","Orbassano"],["Cambridge University Hospitals NHS Foundation Trust","Ince, Will","英国","Cambridgeshire","Cambridge"],["Cancer Institute Hospital of JFCR","Miura, Yuji","日本","东京都","Koto"],["Caritas-Krankenhaus St. Josef-Klinik fuer Urologie","Schnabel, Marco","德国","Bayern","Regensburg"],["Centre Antoine Lacassagne","Borchiellini, Delphine","法国","Alpes-Maritimes","Nice"],["Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology","Laguerre, Brigitte","法国","Ille-et-Vilaine","Rennes"],["Centre Georges Francois Leclerc","Ladoire, Sylvain","法国","Cote-d’Or","Dijon"],["Centre Hospitalier Universitaire de Nimes - Institut de Cancérologie du Gard - Hopital Universitaire","Houede, Nadine","法国","Gard","Nimes"],["Centre intégré de cancérologie du CHU de Québec Université Laval, Hopital de l'Enfant-Jésus","Castonguay, Vincent","加拿大","Quebec","Quebec"],["Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne","Mahammedi, Hakim","法国","Puy-de-Dome","Clermont-Ferrand"],["CENTRE LEON BERARD","Flechon, Aude","法国","Rhone","Lyon Cedex 08"],["Centro Ricerche Cliniche di Verona","Zivi, Andrea","意大利","Veneto","Verona"],["Charité Universitaetsmedizin Berlin - Campus Mitte","De Santis, Maria","德国","Berlin","Berlin"],["CHC Montlegia Clinic","Herman, Lyonel","比利时","Liege","Liege"],["CHRU de Brest","Auberger, Benjamin","法国","Finistere","Brest"],["CHU Amiens Picardie Site Sud Amiens","HOUESSINON, Aline","法国","Somme","Amiens"],["CHU de Bordeaux Hop St ANDRE","Gross-Goupil, Marine","法国","Gironde","Bordeaux"],["Cleveland Clinic - Ohio","Gupta, Shilpa","美国","Ohio","Cleveland"],["Cliniques Universitaires Saint-Luc","Seront, Emmanuel","比利时","Brussels-Capital Region","Brussels"],["Dana Farber Cancer Institute","Bellmunt, Joaquim","美国","Massachusetts","Boston"],["Ehime University Hospital","Saika, Takashi","日本","爱媛县","Toon"],["Elisabeth-TweeSteden Ziekenhuis","Ham, Janneke","荷兰","Noord-Brabant","Tilburg"],["Emory University Hospital","Brown, Jacqueline","美国","Georgia","Atlanta"],["Erasmus Medisch Centrum","Robbrecht, Debbie","荷兰","Zuid-Holland","Rotterdam"],["European Interbalkan Medical Center","Korantzis, Ippokratis","希腊","Central Macedonia","Thessaloniki"],["Fondazione IRCCS Istituto Nazionale Dei Tumori","Guadalupi, Valentina","意大利","Lombardia","Milano"],["Fondazione Policlinico Universitario Agostino Gemelli IRCCS – Università Cattolica del Sacro Cuore","Iacovelli, Roberto","意大利","Lazio","Roma"],["Fox Chase Cancer Center","Ghatalia, Pooja","美国","Pennsylvania","Philadelphia"],["Fred Hutchinson Cancer Center","Grivas, Petros","美国","Washington","Seattle"],["Fundacao Faculdade Regional de Medicina de Sao José do Rio Preto","Ferreira, Luiza","巴西","Sao Paulo","Sao Jose Do Rio Preto"],["General Oncology Hospital of Kifisia","Zakopoulou, Roubini","希腊","Attica","Athens"],["Gifu University Hospital","Nakane, Keita","日本","岐阜县","Gifu"],["Gustave Roussy","Loriot, Yohann","法国","Val-de-Marne","Villejuif"],["H. de Badalona Germans Trias I Pujol","Martin Liberal, Juan","西班牙","Cataluna","Badalona"],["Hirosaki University Hospital","Hatakeyama, Shingo","日本","青森县","Hirosaki"],["Hoag Memorial Hospital Presbyterian","Benjamin, David","美国","California","Newport Beach"],["Hokkaido University Hospital","Abe, Takashige","日本","北海道","Sapporo"],["Hopital Saint-Louis","Dumont, Clement","法国","Paris","Paris"],["Hospital Alemao Oswaldo Cruz","Kann, Ariel","巴西","Sao Paulo","Sao Paulo"],["Hospital Clinico San Carlos","Puente Vazquez, Javier","西班牙","Comunidad de Madrid","Madrid"],["Hospital Italiano de Buenos Aires","Basbus, Luis Roberto","阿根廷","Buenos Aires (CABA)","Ciudad Autonoma De Buenos Aires"],["Hospital Moinhos de Vento","Isaacsson Velho, Pedro","巴西","Rio Grande do Sul","Porto Alegre"],["Hospital Universitari Vall d'Hebron","Morales Barrera, Rafael","西班牙","Cataluna","Barcelona"],["Hospital Universitario 12 de Octubre","Castellano Gauna, Daniel","西班牙","Comunidad de Madrid","Madrid"],["Hospital Universitario Insular de Gran Canaria","Gomez de Liano Lista, Alfonso","西班牙","Canarias","Las Palmas De Gran Canaria"],["Hospital Universitario Marques de Valdecilla","Duran Martinez, Ignacio","西班牙","Cantabria","Santander"],["Hospital Universitario Ramon y Cajal","Gajate Borau, Pablo","西班牙","Comunidad de Madrid","Madrid"],["Hospital Virgen del Rocio","Perez Valderrama, Begona","西班牙","Andalucía","Sevilla"],["Huntsman Cancer Hospital at the University of Utah","Swami, Umang","美国","Utah","Salt Lake City"],["ICTRIALS Pesquisa e Desenvolvimento","Silva, Adriano","巴西","Paraná","Curitiba"],["Institute of Science Tokyo Hospital","Fukuda, Shohei","日本","东京都","Bunkyo"],["Instituto Alexander Fleming","Sade, Juan","阿根廷","Buenos Aires (CABA)","Ciudad Autónoma De Buenos Aires"],["Instituto de Oncologia de Rosario","Mainardi, Nicolas","阿根廷","Santa Fe","Rosario"],["IRCCS Azienda Ospedaliera Metropolitana","Fornarini, Giuseppe","意大利","Liguria","Genova"],["Isala, locatie Zwolle","de Boer, Elianne","荷兰","Overijssel","Zwolle"],["Istituto Clinico Humanitas","Zucali, Paolo","意大利","Lombardia","Rozzano"],["Johns Hopkins University","Hoffman-Censits, Jean","美国","Maryland","Baltimore"],["Kagawa University Hospital","Taoka, Rikiya","日本","香川县","Kita-Gun"],["Karolinska Universitetssjukhuset Solna","Ullen, Anders","瑞典","Stockholms lan","Stockholm"],["Kitasato University Hospital","Matsumoto, Kazumasa","日本","神奈川县","Sagamihara"],["Klinikum Stuttgart - Katharinenhospital","Bedke, Jens","德国","Baden-Wurttemberg","Stuttgart"],["Kobe University Hospital","Hara, Takuto","日本","兵库县","Kobe"],["Kyoto University Hospital","Hamada, Akihiro","日本","京都府","Kyoto"],["Kyushu University Hospital","Matsumoto, Takashi","日本","福冈县","Fukuoka"],["Laenssjukhuset Ryhov","Papantoniou, Dimitrios","瑞典","Jonkopings lan","Jonkoping"],["Lakeridge Health","Zalewski, Pawel","加拿大","Ontario","Oshawa"],["Levine Cancer Institute","Burgess, Earle","美国","North Carolina","Charlotte"],["Maastricht UMC+","Kerkhofs, Thomas","荷兰","Limburg","Maastricht"],["Macquarie University","Zhang, Alison","澳大利亚","New South Wales","Macquarie"],["Marienhospital Herne","Tully, Karl","德国","Nordrhein-Westfalen","Herne"],["Mater Hospital Brisbane","Oliveira, Niara","澳大利亚","Queensland","South Brisbane"],["Memorial Sloan Kettering Cancer Center","Niglio, Scot","美国","New York","New York"],["METROPOLITAN GENERAL HOSPITAL-ONCOLOGIC CLINICAL TRIALS AND RESEARCH CLINIC","BOURNAKIS, EVANGELOS","希腊","Attica","Athens"],["Montefiore Medical Center- Montefiore Medical Park-Oncology","Gartrell, Benjamin","美国","New York","Bronx"],["Morristown Memorial Hospital","Rafelson, William","美国","New Jersey","Morristown"],["Munson Medical Center","Kohler, Peter","美国","Michigan","Traverse City"],["Nagoya University Hospital","Zennami, Kenji","日本","爱知县","Nagoya"],["Nara Medical University Hospital","Miyake, Makito","日本","奈良县","Kashihara"],["Nederlands Kanker Instituut – Antoni van Leeuwenhoek - NKI-AVL","Van der Heijden, Michiel","荷兰","Noord-Holland","Amsterdam"],["North Shore University Health System","Pfanzelter, Nicklas","美国","Illinois","Evanston"],["Ohio State University Hospital","Bicer, Fuat","美国","Ohio","Columbus"],["Osaka Rosai Hospital","Tsujihata, Masao","日本","大阪府","Sakai"],["Ospedale Generale Provinciale Macerata","Battelli, Nicola","意大利","Marche","Macerata"],["Ospedale San Donato. Azienda Sanitaria Toscana Sud Est","Hamzaj, Alketa","意大利","Toscana","Arezzo"],["Princess Margaret Cancer Centre","Sridhar, Srikala","加拿大","Ontario","Toronto"],["Rabin Medical Center","Neiman, Victoria","以色列","Central District","Petah Tikva"],["Rambam Health Care Campus","Peer, Avivit","以色列","Haifa District","Haifa"],["Shaare Zedek Medical Center","Abramovich, Amir","以色列","Jerusalem District","Jerusalem"],["Sheba Medical Center","Gadot, Moran","以色列","Tel Aviv District","Ramat Gan"],["Southampton General Hospital","Crabb, Simon","英国","Hampshire","Southampton"],["St Bartholomew's Hospital","Powles, Thomas","英国","Greater London","London"],["St. Antonius Ziekenhuis, locatie Utrecht","Los, Maartje","荷兰","Utrecht","Utrecht"],["St. Marianna University Hospital","Kikuchi, Eiji","日本","神奈川县","Kawasaki"],["Tennessee Oncology","Beckermann, Kathryn","美国","Tennessee","Nashville"],["The Beatson West of Scotland Cancer Centre","Jones, Robert","英国","Glasgow City","Glasgow"],["The University of Texas MD Anderson Cancer Center","Johns, Andrew","美国","Texas","Houston"],["The West Clinic, P.C.","Somer, Bradley","美国","Tennessee","Germantown"],["Thompson Cancer Survival Center","Tariq, Rizwan","美国","Tennessee","Knoxville"],["TriHealth Cancer Institute-Good Samaritan Hospital","Tefera, Kirubel","美国","Ohio","Cincinnati"],["Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden","Banek, Severine","德国","Sachsen","Dresden"],["Universitaetsklinikum Duesseldorf","Niegisch, Guenter","德国","Nordrhein-Westfalen","Duesseldorf"],["Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum","Von Amsberg, Gunhild","德国","Hamburg","Hamburg"],["Universitaetsklinikum Heidelberg Nationales Centrum fuer Tumorerkrankungen","Zschaebitz, Stefanie","德国","Baden-Wurttemberg","Heidelberg"],["Universitaetsklinikum Ulm-Urologie und Kinderurologie","Zengerling, Friedemann","德国","Baden-Wurttemberg","Ulm"],["Universitatsklinikum Munster - Albert Schweitzer Campus-Klinik fur Urologie","Boegemann, Martin","德国","Nordrhein-Westfalen","Muenster"],["University General Hospital ''Attikon'' - General Hospital of West Attica “H AGIA VARVARA”","Bamias, Aristotelis","希腊","Attica","Chaidari"],["University Hospitals of Cleveland Case Medical Center","Brown, Jason","美国","Ohio","Cleveland"],["University of Arkansas for Medical Sciences","Kunthur, Anuradha","美国","Arkansas","Little Rock"],["University of Chicago","ODonnell, Peter","美国","Illinois","Chicago"],["University Of Colorado Anschutz Medical Campus","Eule, Corbin","美国","Colorado","Aurora"],["University of Tsukuba Hospital","Nagumo, Yoshiyuki","日本","茨城县","Tsukuba"],["UZ Gent","Rottey, Sylvie","比利时","Oost-Vlaanderen","Gent"],["Virginia Oncology Associates (VOA)","Fleming, Mark","美国","Virginia","Hampton"],["WakeMed Raleigh Campus","Chaudhary, Vijay","美国","North Carolina","Raleigh"],["Yitzhak Shamir Medical Center.","Leibowitz, Raya","以色列","Central District","Zerifin"]]
序号 机构名称 主要研究者 国家 省(州) 城市
五、伦理委员会信息
[["复旦大学附属肿瘤医院医学伦理委员会","修改后同意","2026-01-09"]]
序号 名称 审查结论 批准日期/备案日期
六、试验状态信息
1、试验状态
进行中(尚未招募)
2、试验人数
目标入组人数 国内: 40 ; 国际: 590 ;
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;
3、受试者招募及试验完成日期
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;
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