天津TAR-210III期临床试验-一项评估TAR-210与膀胱内化疗在高危非肌层浸润性膀胱癌患者中作用的研究

登记号	CTR20253493	试验状态	进行中
申请人联系人	赵夏	首次公示信息日期	2025-08-29
申请人名称	Janssen Research & Development, LLC/ 强生（中国）投资有限公司/ Janssen Pharmaceutica NV, Division Janssen Research and Development; NACS, Inc/ Catalent Pharma Solutions, LLC; Catalent Germany Schorndorf GmbH; Fisher Clinical Services Inc.; Fisher Clinical Services GmbH

登记号	CTR20253493
相关登记号	暂无
药物名称	TAR-210
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	非肌层浸润性膀胱肿瘤
试验专业题目	一项在接受过膀胱内卡介苗（BCG）治疗的携带易感FGFR变异的高危非肌层浸润性膀胱癌受试者中评价TAR-210 厄达替尼膀胱内给药系统对照研究者选择的膀胱内化疗的疗效和安全性的III期、随机、开放性、多中心研究
试验通俗题目	一项评估TAR-210与膀胱内化疗在高危非肌层浸润性膀胱癌患者中作用的研究
试验方案编号	42756493BLC3005	方案最新版本号	原始版本
版本日期:	2025-05-19	方案是否为联合用药	否

申请人名称	[["Janssen Research & Development, LLC"],["强生（中国）投资有限公司"],["Janssen Pharmaceutica NV, Division Janssen Research and Development; NACS, Inc"],["Catalent Pharma Solutions, LLC; Catalent Germany Schorndorf GmbH; Fisher Clinical Services Inc.; Fisher Clinical Services GmbH"]]
联系人姓名	赵夏	联系人座机	021-33376008	联系人手机号
联系人Email	xzhao122@its.jnj.com	联系人邮政地址	上海市-上海市-徐汇区桂菁路65号新研大厦	联系人邮编	200233

试验的主要目的是比较卡介苗（BCG）治疗后的受试者接受TAR-210治疗与研究者选择膀胱内化疗治疗高危非肌层浸润性膀胱癌（HR-NMIBC）的无病生存期（随机分组后受试者无癌症复发或进展的任何体征或症状的生存时间）。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	开放	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["当地病理学检查结果显示经组织学确诊单纯乳头状HR-NMIBC（高危非肌层浸润性膀胱癌）（定义为HG（高级别）Ta或任何T1，无CIS（原位癌））。如果以尿路上皮分化为主，则允许组织学检查存在混合组织学肿瘤。但将排除神经内分泌和小细胞变异。"],["通过中心实验室或当地实验室的尿液检测或肿瘤组织检测（来自TURBT（经尿道膀胱肿瘤切除）组织）确定携带易感型FGFR突变或融合。"],["在随机化前，所有可见肿瘤均完全切除。在随机化前，尿细胞学检查结果不得为HG（高级别） UC（尿路上皮癌）阳性或可疑。对于进行筛选期活检/TURBT（经尿道膀胱肿瘤切除）时发现固有层浸润（T1）的受试者，必须存在固有肌层以排除MIBC。"],["受试者必须：na) 接受过充分BCG诱导疗程（6剂中的5剂）和BCG维持疗程（3剂中的2剂）或BCG第二次诱导疗程（6剂中的2剂），且诱导治疗后首次疾病评估时发现HG（高级别） T1疾病或BCG末次灌注后6个月内发现HG（高级别） Ta/任何T1疾病（BCG无应答人群）。或，nb) 接受过充分BCG诱导疗程（5或6剂）、接受或未接受BCG维持治疗且BCG末次灌注后12个月内发现HG（高级别） Ta/任何T1疾病，不包括BCG无应答的受试者（BCG经治人群）。或，nc) 因≥2级毒性需要停用BCG而无法完成至少5剂的BCG诱导疗程（BCG不耐受人群）。"],["ECOG（美国东部肿瘤协作组）体能状态评分等级为0、1或2。"],["受试者必须不适合或拒绝RC（根治性膀胱切除术）。"]]
排除标准	[["从诊断为单纯乳头状HR-NMIBC（高危非肌层浸润性膀胱癌）复发至随机化期间的任何时间点发现CIS（原位癌）。此外，存在或既往存在经组织学确诊的肌层浸润性、局部晚期、不可切除或转移性UC（尿路上皮癌）（即T2、T3、T4、N＋和/或M＋）。"],["研究治疗疾病以外的活动性恶性肿瘤（即，过去24个月内疾病进展或需要改变治疗）。允许的近期继发性或既往恶性肿瘤：na) 过去12个月内未出现疾病进展或不需要改变治疗的任何恶性肿瘤。nb) 过去12个月内接受治疗的恶性肿瘤，并认为复发风险极低：ni. 接受根治性治疗的非黑色素瘤皮肤癌或仅接受根治性手术切除治疗的局部黑色素瘤。nii. 非浸润性宫颈癌。niii. 乳腺癌：充分治疗的小叶CIS（原位癌）或导管CIS（原位癌）、局部乳腺癌并接受抗激素药物。niv. Gleason评分≤7a且仅接受局部治疗（RP（根治性前列腺切除术）/RT（放疗）/局灶性治疗）的局限性前列腺癌（N0，M0）。nv. 认为复发风险极低的其他恶性肿瘤。"],["研究者认为存在任何膀胱或尿道解剖特征可能会妨碍TAR-210的安全放置、留置或取出。"],["存在有临床意义的多尿病史（记录的24小时尿量＞4,000 mL）。"],["不允许使用留置导管；但间歇性导尿术可接受。"]]

试验药	[["中文通用名:TAR-210(JNJ-42756493) 英文通用名:TAR-210(JNJ-42756493) 商品名称:NA","剂型:膀胱内给药系统 规格:每个TAR-210含500mg厄达替尼 用法用量:每12周置入膀胱1次 用药时程:治疗周期约2年"]] 序号 名称 用法
对照药	[["中文通用名:吉西他滨 英文通用名:Gemcitabine 商品名称:NA","剂型:悬浮液 规格:2000mg-膀胱灌注 用法用量:按每周1次给药,4-6剂诱导给药，之后每月1次，维持1年稳定剂量。之后，研究者可酌情决定是否进行可选的第二年额外维持治疗。 用药时程:参与者将会接受每周1次给药,4-6剂诱导给药，之后每月1次维持1年稳定剂量。"],["中文通用名:丝裂霉素C 英文通用名:Mitomycin-C 商品名称:NA","剂型:悬浮液 规格:40mg-膀胱灌注 用法用量:按每周1次给药,4-6剂诱导给药，之后每月1次，维持1年稳定剂量。之后，研究者可酌情决定是否进行可选的第二年额外维持治疗。 用药时程:参与者将会接受每周1次给药,4-6剂诱导给药，之后每月1次维持1年稳定剂量。"]] 序号 名称 用法

主要终点指标及评价时间

[["无病生存期DFS","至多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

[["无复发生存期RFS","至多5年","有效性指标"],["至下一线治疗的时间TTNI","至多5年","有效性指标"],["至疾病恶化时间TTDW","至多5年","有效性指标"],["至疾病进展时间TTP","至多5年","有效性指标"],["总生存OS","至多5年","有效性指标+安全性指标"],["根据不良事件通用术语标准（CTCAE）5.0版本出现不良事件（AE）的受试者人数","至多5年","安全性指标"],["发生较基线变化的实验室异常受试者人数","至多5年","安全性指标"],["发生较基线变化的生命体征异常受试者人数","至多5年","安全性指标"],["欧洲癌症研究与治疗组织生活质量问卷（EORTC QLQ）-C30评分较基线的变化","基线、第12、24、36、48、60、72、84和96周","有效性指标+安全性指标"],["EORTC QLQ-非肌层浸润性膀胱癌（NMIBC）24评分较基线的变化","基线、第12、24、36、48、60、72、84和96周","有效性指标+安全性指标"],["EORTC-QLQ-C30评分较基线有显著变化的受试者百分比","第12、24、36、48、60、72、84和96周","有效性指标+安全性指标"],["EORTC-QLQ-NMIBC24评分较基线有显著变化的参与者百分比","第12、24、36、48、60、72、84和96周","有效性指标+安全性指标"],["EORTC问卷168（Q168）评估的总体副作用受试者人数","至多96周","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	胡海龙	学位	医学博士	职称	主任医师
	电话	022-88326483	Email	huhailong_yd2y@163.com	邮政地址	天津市-天津市-河西区平江道23号
	邮编	300211	单位名称	天津医科大学第二附属医院

[["天津医科大学第二附属医院","胡海龙","中国","天津市","天津市"],["中山大学孙逸仙纪念医院","林天歆","中国","广东省","广州市"],["成都市第三人民医院","邱明星","中国","四川省","成都市"],["四川大学华西医院","魏强","中国","四川省","成都市"],["南京大学医学院附属鼓楼医院","郭宏骞","中国","江苏省","南京市"],["华中科技大学同济医学院附属同济医院","王少刚","中国","湖北省","武汉市"],["北京大学第一医院","张崔建","中国","北京市","北京市"],["宁波大学附属第一医院","马琪","中国","浙江省","宁波市"],["温州医科大学附属第一医院","陈伟","中国","浙江省","温州市"],["Hospital Sirio Libanes","Hernan Cutuli","阿根廷","Ciudad Autonoma de Buenos Aires","Ciudad Autonoma de Buenos Aires"],["Centro Urologico Profesor Bengio","Ruben Bengio","阿根廷","Cordoba","Cordoba"],["Sanatorio de la Mujer","Herman Andres Perroud","阿根廷","Santa Fe","Rosario"],["Instituto Alexander Fleming","Martin Angel","阿根廷","Cdad. Autónoma de Buenos Aires","Ciudad Autónoma de Buenos AireS"],["Investigaciones Clinico Moleculares (ICM)","Fernando Galanternik","阿根廷","Cdad Autonoma de Buenos Aires","Caba"],["Ziekenhuis Oost-Limburg","Yannic Raskin","比利时","Vlaams Gewest","Genk"],["AZ Maria Middelares","Karel Decaestecker","比利时","Vlaams Gewest","Gent"],["Universitair Ziekenhuis Leuven","Ben Van Cleynenbreugel","比利时","Vlaams Gewest","Leuven"],["Algemeen Ziekenhuis Delta","Lieven Goeman","比利时","NA","Roeselare"],["HOPITAL ERASME","Thierry Roumeguere","比利时","NA","Brussel"],["Hospital Regional do Cancer - Hospital de Esperanca","Felipe De Almeida E Paula","巴西","SP","Presidente Prudente"],["Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo","Claudio Murta","巴西","SP","Sao Paulo"],["Real e Benemerita Associacao Portuguesa de Beneficencia","Marcelo Wroclawski","巴西","SP","Sao Paulo"],["Liga Norte Riograndense Contra O Cancer","Andrea Juliana Pereira De Santana Gomes","巴西","RN","Natal"],["Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto","Fabio Leite Fernandez","巴西","SP","Sao Jose do Rio Preto"],["Hopital Saint Louis","Alexandra Masson-lecomte","法国","NA","Paris"],["Hopital Saint Joseph","Constance Michel","法国","NA","Paris"],["Institut Paoli Calmettes","Geraldine Pignot","法国","NA","Marseille"],["Clinique de la Croix du Sud","Benjamin Pradere","法国","Occitanie","Quint Fonsegrives"],["Gustave Roussy","Yohann Loriot","法国","NA","Villejuif Cedex"],["CHU Pitie Salpetriere","Morgan Roupret","法国","NA","Paris"],["CHP Saint Gregoire","Romain Huet","法国","NA","SAINT GREGOIRE"],["Universitaetsklinikum Mannheim","Niklas Westhoff","德国","NA","Mannheim"],["Caritas-Krankenhaus St. Josef","Marco Schnabel","德国","BY","Regensburg"],["Marien hospital Herne","Florian Roghmann","德国","NRW","Herne"],["Universitaetsklinikum Koeln","Axel Heidenreich","德国","NRW","Koln"],["Klinikum Leverkusen gGmbH","Daniel Porres","德国","NRW","Leverkusen"],["Studienpraxis Urologie Nurtingen","Tilman Todenhoefer","德国","NA","Nürtingen"],["Athens Medical Center S A Interbalkan Medical Center of Thessaloniki","Petros Sountoulidis","希腊","NA","Thessaloniki"],["LAIKO GENERAL HOSPITAL OF ATHENS","Konstantinos Stravodimos","希腊","NA","Athina"],["General Hospital of Athens G Gennimatas","Konstantinos Doumas","希腊","NA","Athina"],["Sismanogleio General Hospital","Andreas Skolarikos","希腊","NA","Athens"],["General Hospital Of Thessaloniki Papageorgiou","Konstantinos Hatzimouratidis","希腊","NA","Thessaloniki"],["Carmel Medical Center","Yuval Freifeld","以色列","NA","Hifa"],["Meir Medical Center","Miki Haifler","以色列","HaMerkaz","Kfar Saba"],["Sheba Medical Center","Zohar Dotan","以色列","Tel Aviv District","Ramat Gan"],["Rabin Medical Center","Shay Golan","以色列","Center District","Petah Tikva"],["Rambam Medical Center","Gilad Amiel","以色列","Haifa District","Haifa"],["Tel Aviv Sourasky Medical Center","Ofer Yossepowitch","以色列","Tel Aviv District","Tel Aviv Yafo"],["Ospedale San Raffaele","Andrea Necchi","意大利","NA","Milano"],["Fondazione G Pascale Istituto Nazionale Tumori IRCCS","Sandro Pignata","意大利","Campania","Napoli"],["Istituto Nazionale Tumori Regina Elena","Giuseppe Simone","意大利","NA","Roma"],["Cliniche Humanitas Gavazzeni","Angelo Porreca","意大利","Lombardia","Bergamo"],["Aou San Luigi Gonzaga","Francesco Porpiglia","意大利","Torino","Orbassano"],["ASST Spedali Civili Brescia","Nazareno Roberto Suardi","意大利","NA","Brescia"],["Ospedale S. Maria Della Misericordia","Alessandro Crestani","意大利","NA","Udine"],["SPDC Villa Scassi","Alessia Cavo","意大利","Liguria","Genova"],["Yokohama City University Medical Center","Takashi Kawahara","日本","Kanagawa","Yokohama"],["St Marianna University Hospital","Eiji Kikuchi","日本","Kanagawa","Kawasaki City"],["The Jikei University Hospital","Tsuzuki Shunsuke","日本","NA","Tokyo"],["Juntendo University Hospital","Masayoshi Nagata","日本","Tokyo","Bunkyo Ku"],["Yokohama Municipal Citizen's Hospital","Junichi Ohta","日本","Kanagawa","Yokohama"],["Toho University Sakura Medical Center","Naoto Kamiya","日本","Chiba","Sakura"],["Hakodate Goryoukaku Hospital","Atsushi Takahashi","日本","Hokkaido","Hakodate"],["Funabashi Municipal Medical Center","Satoshi Fukasawa","日本","Chiba","Funabashi shi"],["Seoul National University Hospital","Hyeong Dong Yuk","韩国","NA","Seoul"],["Severance Hospital Yonsei University Health System","Won Sik Ham","韩国","NA","Seoul"],["Chungbuk National University Hospital","Seokjoong Yun","韩国","Chungcheongbuk do","Cheongju"],["Samsung Medical Center","Byong Chang Jeong","韩国","Seoul","Gangnam gu"],["Seoul National University Bundang Hospital","Jongjin Oh","韩国","Gyeonggido [Kyonggi-do]","Seongnam-si"],["Erasmus MC","Joost Boormans","荷兰","GD","Rotterdam"],["Canisius-Wilhelmina ZH","Rik Somford","荷兰","GE","Nijmegen"],["Radboud Umcn","Antoine Van Der Heijden","荷兰","GE","Nijmegen"],["UMC Utrecht","Richard P Meijer","荷兰","UT","Utrecht"],["HOSP. DE JEREZ DE LA FRONTERA","Nelson Canales","西班牙","Cádiz","Jerez de la Frontera"],["HOSP. PUERTA DEL MAR","Jesus Rosety Rodriguez","西班牙","Cádiz","Cadiz"],["HOSP VIRGEN DE LA VICTORIA","Bernardo Herrera","西班牙","NA","Malaga"],["HOSP. GRAL. UNIV. DE CASTELLON","Miguel Rodrigo","西班牙","NA","Castellon"],["HOSP. UNIV. 12 DE OCTUBRE","Felix Guerrero Ramos","西班牙","MD","Madrid"],["HOSP.UNIV.PARC TAULI","Arturo Dominguez Garcia","西班牙","CT","Sabadell"],["HOSP. CLINIC DE BARCELONA","Antoni Vilaseca Cabo","西班牙","CT","Barcelona"],["HOSP UNIV A CORUNA","Sara Martínez Breijo","西班牙","NA","A Coruna"],["HOSP. ARQUITECTO MARCIDE","Andres Rodriguez Alonso","西班牙","NA","Ferrol"],["Royal Marsden Hospital","Pardeep Kumar","英国","England","Surrey"],["Lister Hospital","Nikhil Vasdev","英国","England","Stevenage"],["Hull University Teaching Hospitals NHS Trust","Matthew Simms","英国","East Yorkshire","Cottingham"],["Southampton University Hospital","James Douglas","英国","England","Southampton"],["St Bartholomews Hospital","Bernadett Szabados","英国","NA","London"],["University of Pittsburgh Medical Center","Jodi Maranchie","美国","PA","Pittsburgh"],["Colorado Clinical Research","David Cahn","美国","CO","Lakewood"],["New Jersey Urology LLC","Gordon Brown","美国","NJ","Voorhees"],["UroPartners","Aaron Berger","美国","IL","Chicago Ridge"],["Texas Oncology-Austin","Kyle Keyes","美国","TX","Austin"],["Urology Austin","Brian Mazzarella","美国","TX","Austin"],["University of California, Los Angeles UCLA","Karim Chamie","美国","CA","Los Angeles"],["Bon Secours Saint Francis Cancer Center","Stephen Dyar","美国","SC","Greenville"],["SouthWest Urology Middleburg Heights","Lawrence Gervasi","美国","OH","Middleburg Heights"],["The Conrad Pearson Clinic","Paul Eber","美国","TN","Germantown"],["Georgia Urology","Daniel Canter","美国","GA","Atlanta"],["Associated Medical Professionals","Ilija Aleksic","美国","NY","Syracuse"],["The Urology Center, PC","Judson Davies","美国","NE","Omaha"],["Dayton Physicians Network Urology","David Key","美国","OH","Centerville"],["MidLantic Urology","Laurence Belkoff","美国","PA","Bala Cynwyd"],["Urology of Indiana","Chad Reichard","美国","IN","Carmel"],["Carolina Urologic Research Center","Neal Shore","美国","SC","Myrtle Beach"],["Urology San Antonio Research","Daniel Zainfeld","美国","TX","San Antonio"],["The Urology Group","Marc Pliskin","美国","OH","Cincinnati"],["Comprehensive Urology","Adam Gadzinski","美国","MI","Royal Oak"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["天津医科大学第二医院医学伦理委员会","同意","2025-07-07"]]

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: 18 ； 国际: 220 ；
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；