Sacituzumab Govitecan-hziy (IMMU-132) 与医生选择治疗转移性或局部晚期不可切除尿路上皮癌参与者的研究 (TROPiCS-04)
2026年5月6日 更新者：Gilead Sciences
在患有转移性或局部晚期不可切除尿路上皮癌的受试者中，Sacituzumab Govitecan 与医生选择的治疗的随机开放标签 III 期研究
本研究的主要目的是评估 sacituzumab govitecan-hziy 与医生选择的治疗 (TPC) 相比，在患有转移性或局部晚期不可切除的尿路上皮癌 (UC) 的参与者中的总生存期 (OS)。
研究概览
研究类型
介入性
注册 (实际的)
711
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Beijing、中国、100142
- Beijing Cancer Hospital
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Beijing、中国、100034
- Peking University First Hospital
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Beijing、中国、100039
- Chinese People's Liberation Army General Hospital - 301 Hospital
-
Beijing、中国、100730
- Chinese Academy of Medical Sciences Cancer Hospital
-
Changchun、中国、130021
- 1st Hospital Jilin University
-
Changsha、中国、410013
- Hunan Cancer Hospital - Xiangya Hospital - Central South University
-
Chengdu、中国、610041
- West China Hospital Sichuan University
-
Chengdu、中国、610072
- Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People's Hospital
-
Chongqing、中国、400030
- Chongqing University Cancer Hospital
-
Fujian、中国、350005
- The First Affiliated Hospital of Fujian Medical University
-
Fuzhou、中国、350001
- Union Hospital of Fujian Medical University
-
Guangzhou、中国、510060
- Sun Yat-sen University Cancer Center
-
Hangzhou、中国、310014
- Zhejiang Provincial People's Hospital - Zhaohui
-
Hangzhou、中国、310022
- Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital
-
Hefei、中国、230031
- AnHui Provincial Cancer Hospital
-
Jinan、中国、250012
- Qilu Hospital of Shandong University
-
Nanchang、中国、330006
- The First Affiliated Hospital of Nanchang University
-
Nanjing、中国、210008
- Nanjing Drum Tower Hospital
-
Shenyang、中国、110042
- Liaoning Cancer Hospital and Institute
-
Tianjin、中国、300060
- Tianjin Medical University Cancer Institute & Hospital
-
Wenzhou、中国、325000
- The First Affiliated Hospital of Wenzhou Medical University
-
Wuhan、中国、430030
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
-
Ürümqi、中国、830000
- Affiliated Tumor Hospital of Xinjiang Medical University
-
-
-
-
-
Batumi、乔治亚州、6000
- High Technology Hospital Medcenter
-
Tbilisi、乔治亚州、0114
- New Hospitals
-
Tbilisi、乔治亚州、0144
- L. Managadze National Center of Urology
-
Tbilisi、乔治亚州、0160
- Evex Medical corporation
-
Tbilisi、乔治亚州、0167
- Jerarsi Clinic
-
-
-
-
-
Be’er Ya‘aqov、以色列、7030000
- Shamir Medical Center (Assaf Harofeh)
-
Haifa、以色列、3109601
- Rambam Health Care Campus
-
Jerusalem、以色列、91120
- Hadassah University Hospital Ein Kerem
-
Kfar Saba、以色列、44281
- Meir Medical Center
-
Petah Tikva、以色列、4941492
- Rabin Medical Center
-
Tel Aviv、以色列、6423906
- Tel Aviv Medical Center (Ichilov Hospital)
-
Tel Litwinsky、以色列、52621
- Chaim Sheba Medical Center
-
-
-
-
-
Pleven、保加利亚、5800
- Multiprofile Hospital for Active Treatment Heart and Brain EAD
-
Sofia、保加利亚、1233
- Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District
-
-
-
-
-
Split、克罗地亚、21000
- Clinical Hospital Centre Split
-
Zagreb、克罗地亚
- University Hospital Centre Zagreb
-
Zagreb、克罗地亚、10000
- Clinical Hospital Centre "Sestre Milosrdnice"
-
-
-
-
-
Edmonton、加拿大、T6G 1Z2
- Cross Cancer Institute
-
Halifax、加拿大、B3H 2Y9
- qeii health sciences centre - VG site
-
Hamilton、加拿大、L8V 5C2
- Juravinski Hospital and Cancer Centre
-
London、加拿大、N6A 4G5
- London Health Sciences Centre
-
Montreal、加拿大、H3T 1E2
- Jewish General Hospital
-
Montreal、加拿大、H4A 3J1
- McGill University Health Centre
-
Oshawa、加拿大、L1G 2B9
- R.S. McLaughlin Durham Regional Cancer Centre
-
Toronto、加拿大、M5G 2M9
- Princess Margaret Cancer Centre
-
Vancouver、加拿大、V5Z 4E6
- British Columbia Cancer Agency-Vancouver Centre
-
-
-
-
-
Buzi、台湾、613
- Chiayi Chang Gung Memorial Hospital
-
Kaohsiung City、台湾、833
- Kaohsiung Chang Gung Memorial Hospital
-
Kaohsiung City、台湾、813
- Kaohsiung Veterans General Hospital
-
New Taipei City、台湾、231405
- Taipei Tzu Chi General Hospital
-
Taichung、台湾、40447
- China Medical University Hospital
-
Taichung、台湾、Taiwan 407
- Taichung Veterans General Hospital
-
Tainan、台湾、70403
- National Cheng Kung University Hospital
-
Taipei、台湾、100
- National Taiwan University Hospital
-
Taipei、台湾、11217
- Taipei Veterans General Hospital
-
Taoyuan、台湾、333
- Chang Gung Memorial Hospital - Linkou Branch
-
-
-
-
-
Ankara、土耳其（türkiye）、6230
- Hacettepe Universitesi Tip Fakultesi- Kanser Enstitusu
-
Edirne、土耳其（türkiye）、22030
- Trakya Üniversitesi Saglik Arastirma ve Uygulama Merkezi
-
Istanbul、土耳其（türkiye）、34214
- Bagcilar Medipol Mega Universite Hastanesi
-
Istanbul、土耳其（türkiye）、34457
- Istanbul Acibadem University Maslak Hospital
-
Istanbul、土耳其（türkiye）、34722
- T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
-
Izmir、土耳其（türkiye）、35575
- Medical Park Izmır Hastanesi
-
Mamak、土耳其（türkiye）、6620
- Cebeci Hastanesi
-
Şişli、土耳其（türkiye）、34365
- VKV Amerikan Hastanesi Department of Oncology
-
-
-
-
-
Graz、奥地利、8036
- Universitätsklinik für Innere Medizin Graz
-
Linz、奥地利、4010
- Ordensklinikum Linz GmbH Barmherzige Schwestern
-
Vienna、奥地利、1020
- Krankenhaus der Barmherzigen Brüder Wien
-
-
-
-
-
Athens、希腊、11528
- Alexandra General Hospital
-
Athens、希腊、115 25
- 401 General Military Hospital Of Athens
-
Athens、希腊、115 26
- Henry Dunant hospital
-
Chaïdári、希腊、124 62
- Attikon Hospital
-
Herakleio、希腊、81352
- Regional University General Hospital of Herakleio, Crete
-
Ioannina、希腊、45332
- University Hospital of Ioannina
-
Larissa、希腊、413 34
- University Hospital of Larissa
-
Marousi、希腊、151 25
- Athens Medical Center
-
Pátrai、希腊、26332
- University Hospital of Patras
-
Thessaloniki、希腊、546 22
- Bioclinic - Thessaloniki
-
Thessaloniki、希腊、546 39
- Theagenio Anticancer Hospital of Thessaloniki
-
Thessaloniki、希腊、54623
- Anassa General Clinic
-
Thessaloniki、希腊、555 35
- Interbalkan Medical Center of Thessaloniki
-
-
-
-
-
Dresden、德国、01307
- Universitatsklinik Dresden
-
Erlangen、德国、91054
- Malteser Waldkrankenhaus Erlangen
-
Essen、德国、45147
- Universitätsklinikum Essen
-
Frankfurt am Main、德国、60389
- Centrum fur Hamatologie und Onkologie Bethanien
-
Hamburg、德国、22763
- Asklepios Klinik Altona
-
Koblenz、德国、56068
- Institut für Versorgungsforschung in der Onkologie
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Münster、德国、48149
- Universitätsklinikum Münster
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Nürtingen、德国、72622
- Studienpraxis Urologie
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Tübingen、德国、72076
- Universitatsklinikum Tubingen
-
Wien、德国、1100
- Charité Universitätsmedizin Berlin - Campus Benjamin Franklin
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-
-
-
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Arezzo、意大利、52100
- Ospedale San Donato
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Aviano、意大利、33081
- Centro Di Riferimento Oncologico Di Aviano
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Bari、意大利、70124
- Istituto Tumori Bari Giovanni Paolo II - IRCCS
-
Candiolo (TO)、意大利、10060
- Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia
-
Genova、意大利、16132
- Ospedale Policlinico San Martino
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Meldola、意大利、47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milan、意大利、20132
- Ospedale San Raffaele
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Novara、意大利、28100
- Azienda Ospedaliero Universitaria Maggiore della Carità
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Pisa、意大利、56126
- Azienda Ospedaliero Universitaria Pisana
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Roma、意大利、00144
- Istituto Regina Elena
-
Rome、意大利、00128
- Università Campus Bio-Medico di Roma
-
Sondrio、意大利、23100
- Ospedale Civile Di Sondrio
-
Terni、意大利、05100
- Azienda ospedaliera Santa Maria di Terni
-
Torino、意大利、10043
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
-
Trento、意大利、38122
- Ospedale di Trento - Presidio Ospedaliero Santa Chiara
-
Verona、意大利、37126
- Azienda Ospedaliera Universitaria Integrata Verona
-
-
-
-
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Olomouc、捷克语、775 20
- Fakultni Nemocnice Olomouc
-
Prague、捷克语、120 00
- Urocentrum Praha
-
-
-
-
-
Singapore、新加坡、119074
- National University Hospital
-
Singapore、新加坡、308433
- Tan Tock Seng Hospital
-
Singapore、新加坡、217562
- Icon Cancer Centre Farrer Park
-
-
-
-
-
Charleroi、比利时、6000
- Grand Hôpital De Charleroi - Notre Dame
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Ghent、比利时、9000
- Az Maria Middelares Ghent
-
Ghent、比利时、9000
- Universitair Ziekenhuis Gent
-
Leuven、比利时、3000
- Universitair Ziekenhuis Leuven
-
Liège、比利时、B-4000
- Centre Hospitalier Universitaire de Liege
-
-
-
-
-
Bayonne、法国
- Ramsay Health Clinic Belharra
-
Bordeaux、法国、33075
- CHU Saint Andre
-
Brest、法国、29200
- Centre Hospiltalier Universitaire Brest - Hôpital Morvan
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Caen、法国、14076
- Centre François Baclesse
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Clermont-Ferrand、法国、63011
- Centre Jean Perrin
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Dijon、法国、21000
- Centre Georges- Francois Leclerc
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La Roche-sur-Yon、法国、85925 CEDEX 9
- Centre Hospitalier Departemental Vendee
-
Lille、法国、59000
- Centre Oscar Lambret
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Lyon、法国、69373
- Centre Léon Bérard
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Montpellier、法国、34090
- Institut Régional du Cancer de Montpellier ICM Val d' Aurelle
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Nice、法国、06189
- Centre Antoine Lacassagne
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Nîmes、法国、30029
- Centre Hospitalier Universitaire de Nîmes
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Paris、法国、75015
- Hôpital Européen Georges-Pompidou
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Rennes、法国、35042
- Centre Eugene Marquis
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Saint-Grégoire、法国、35760
- Centre hospitalier Privé Saint-Grégoire
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Strasbourg、法国、67091
- Les Hopitaux Universitaires de Strasbourg
-
Suresnes、法国、92150
- Hôpital Foch
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Toulouse、法国、31059
- Institut Claudius Regaud
-
Villejuif、法国、94805
- Institut Gustave Roussy
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PR
-
San Juan、PR、波多黎各、00907
- Brcr Medical Center, Inc
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-
-
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New South Wales
-
North Ryde、New South Wales、澳大利亚、2109
- Chris O'Brien Lifehouse
-
Waratah、New South Wales、澳大利亚、2298
- Calvary Mater Newcastle
-
Westmead、New South Wales、澳大利亚、2145
- Westmead Hospital
-
-
Queensland
-
Auchenflower、Queensland、澳大利亚、4066
- Icon Cancer Centre Wesley
-
-
South Australia
-
Bedford Park、South Australia、澳大利亚、5042
- Southern Adelaide Local Health Network Incorporated
-
Kurralta Park、South Australia、澳大利亚、5037
- Ashford Cancer Centre Research - ICON Cancer Centre Adelaide
-
-
Tasmania
-
Hobart、Tasmania、澳大利亚、7001
- Icon Cancer Centre Hobart
-
-
Victoria
-
Clayton、Victoria、澳大利亚、3168
- Monash Health
-
Heidelberg、Victoria、澳大利亚、3084
- Austin Health
-
Melbourne、Victoria、澳大利亚、3000
- Peter MacCallum Cancer Centre
-
Saint Albans、Victoria、澳大利亚、3021
- Sunshine Hospital
-
-
Western Australia
-
Nedlands、Western Australia、澳大利亚、6009
- Sir Charles Gairdner Hospital
-
Nedlands、Western Australia、澳大利亚、6009
- Liverpool Hospital
-
-
-
-
-
Dublin、爱尔兰、D24 NR0A
- Tallaght University Hospital
-
Waterford、爱尔兰、X91 ER8E
- University Hospital Waterford
-
-
-
-
-
Jönköping、瑞典、553 05
- Länssjukhuset Ryhov
-
Linköping、瑞典、581 85
- Universitetssjukhuset i Linköping
-
Stockholm、瑞典、171 76
- Karolinska Universitetssjukhuset - Solna
-
-
-
-
-
Basel、瑞士、4051
- University Hospital Basel
-
Bellinzona、瑞士、6500
- Istituto Oncologico della Svizzera Italiana (IOSI)
-
Bern、瑞士、3010
- University of Bern
-
Geneva、瑞士、1205
- Hopitaux Universitaires de Geneve
-
Zurich、瑞士、8091
- Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie
-
-
-
-
Arizona
-
Phoenix、Arizona、美国、85054
- Mayo Clinic - Arizona
-
-
California
-
Los Angeles、California、美国、90095
- UCLA Hematology/ Oncology
-
Orange、California、美国、92868
- University of California Irvine (UCIMC)
-
-
District of Columbia
-
Washington D.C.、District of Columbia、美国、20010
- MedStar Washington Hospital Center
-
-
Florida
-
Jacksonville、Florida、美国、32207
- Baptist MD Anderson Cancer Center
-
Plantation、Florida、美国、33322
- Boca Raton Clinical Research Global USA - Plantation
-
-
Iowa
-
Iowa City、Iowa、美国、52242
- University of Iowa Hospitals and Clinics
-
-
Maryland
-
Baltimore、Maryland、美国、21201
- University of Maryland School of Medicine
-
-
Massachusetts
-
Boston、Massachusetts、美国、02215
- Beth Israel Deaconess Medical Center
-
-
New York
-
Buffalo、New York、美国、14263
- Roswell Park Cancer Institute
-
New York、New York、美国、10065
- Weill Cornell Medical College
-
The Bronx、New York、美国、10467
- Montefiore Medical Center
-
-
Ohio
-
Cleveland、Ohio、美国、44195
- Cleveland Clinic
-
-
Oklahoma
-
Tulsa、Oklahoma、美国、74104
- Oklahoma Cancer Specialists and Research Institute (OCSRI)
-
-
Pennsylvania
-
Hershey、Pennsylvania、美国、17033
- Penn State Hershey Cancer Institute
-
-
Tennessee
-
Knoxville、Tennessee、美国、37916
- Thompson Oncology Group - Knoxville Downtown
-
Knoxville、Tennessee、美国、37920
- University Cancer Specialists - Knoxville
-
-
Texas
-
Dallas、Texas、美国、75390
- Harold C. Simmons Comprehensive Cancer Center
-
Fort Worth、Texas、美国、76104
- Center for Cancer and Blood Disorders
-
-
Washington
-
Seattle、Washington、美国、98109
- Seattle Cancer Care Alliance (SCCA)
-
Spokane、Washington、美国、99208
- Summit Cancer Centers
-
-
-
-
-
Birmingham、英国、B15 2WB
- University Hospitals Birmingham NHS Foundation Trust
-
Dorchester、英国、DT1 2JY
- Dorset County Hospital NHS Foundation Trust
-
Glasgow、英国、G12 0YN
- NHS Greater Glasgow and Clyde
-
London、英国、EC1A 7BE
- Barts Health NHS Trust
-
London、英国、W1G 6AD
- Sarah Cannon Research Institute London
-
London、英国、SE1 9RT
- Guys and Saint Thomas NHS Foundation Trust, Guy's Hospital
-
Manchester、英国、M20 4BX
- The Christie NHS Foundation Trust
-
Middlesex、英国、HA6 2RN
- East and North Hertfordshire NHS Trust
-
Oxford、英国、OX3 7LE
- Oxford University Hospitals NHS Foundation Trust
-
Port Talbot、英国、SA12 7BR
- Swansea Bay University Health Board
-
Preston、英国、PR2 9HT
- Royal Preston Hospital
-
Surrey、英国、SM2 5PT
- The Royal Marsden NHS Foundation Trust
-
Wolverhampton、英国、WV10 0QP
- The Royal Wolverhampton NHS Trust
-
-
-
-
-
Braga、葡萄牙、4710-243
- Hospital de Braga
-
Guarda、葡萄牙、6300-858
- Unidade Local de Saúde da Guarda - Hospital Sousa Martins
-
Leiria、葡萄牙、2410-197
- Centro Hospitalar de Leiria - Hospital de Santo André
-
Lisbon、葡萄牙、1649-035
- Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria
-
Porto、葡萄牙
- Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E
-
Vila Real、葡萄牙、5000
- Centro Hospitalar de Tras-os-Montes e Alto Douro
-
-
-
-
-
Barcelona、西班牙、08035
- Hospital Universitari Vall d'Hebron
-
Barcelona、西班牙、8036
- Hospital Clinic de Barcelona
-
Barcelona、西班牙、08003
- Hospital del Mar - Parc de Salut
-
Córdoba、西班牙、14004
- Hospital Reina Sofía
-
Madrid、西班牙、28027
- Clinica Universidad de Navarra - Madrid
-
Madrid、西班牙、28034
- Hospital Universitario Ramon y Cajal
-
Madrid、西班牙、28041
- Hospital Universitario 12 de Octubre
-
Madrid、西班牙、28007
- Hospital General Universitario Gregorio Marañón
-
Madrid、西班牙、28033
- MD Anderson Cancer Center
-
Majadahonda、西班牙、28222
- Hospital Universitario Puerta de Hierro de Majadahonda
-
Manresa、西班牙、08243
- Hospital Sant Joan de Deu de Manresa
-
Ourense、西班牙、32005
- Complexo Hospitalario de Ourense (CHOU)
-
Pamplona、西班牙、31008
- Clinica Universidad de Navarra
-
Santander、西班牙、39008
- Hospital Universitario Marqués de Valdecilla
-
Seville、西班牙、41013
- Hospital Universitario Virgen del Rocío
-
Vigo、西班牙、36213
- Álvaro Cunqueiro Hospital
-
-
-
-
-
Busan、韩国、49241
- Pusan National University Hospital
-
Cheongju-si、韩国、361-711
- Chungbuk National University Hospital
-
Daejeon、韩国、35015
- Chungnam National University Hospital
-
Goyang-si、韩国、10408
- National Cancer Center
-
Gyeongsangnam-do、韩国、50612
- Pusan National University Yangsan Hospital
-
Incheon、韩国、405-760
- Gachon University Gil Medical Center
-
Seongnam-si、韩国、13620
- Seoul National University Bundang Hospital
-
Seoul、韩国、03080
- Seoul National University Hospital
-
Seoul、韩国、05505
- Asan Medical Center
-
Seoul、韩国、06351
- Samsung Medical Center
-
Seoul、韩国、03722
- Severance Hospital, Yonsei University Health System
-
Seoul、韩国、137-040
- The Catholic University of Korea Seoul Saint Mary's Hospital
-
Suwon、韩国、16247
- The Catholic University of Korea Saint Vincent's Hospital
-
-
-
-
-
Hong Kong、香港
- Queen Mary Hospital
-
Hong Kong、香港
- Prince of Wales Hospital
-
Kowloon、香港
- Hong Kong United Oncology Centre
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
关键纳入标准：
具有组织学记录的转移性或局部晚期不可切除 UC 的个体定义为
- 肿瘤 (T) 4b，任何淋巴结 (N) 或
- 允许任何T、N 2-3 上下尿路肿瘤。 如果尿路上皮是主要组织学，则允许混合组织学类型。
- 东部肿瘤协作组 (ECOG) 体能状态 (PS) 评分为 0 或 1。
接受含铂方案和抗程序性细胞死亡蛋白 1/程序性死亡配体 1 (PD-1/PD-L1) 治疗转移性或局部晚期不可切除疾病后进展或复发的个体将被纳入。
- 一种。在新辅助/辅助环境中给予含顺铂化疗完成后 ≤ 12 个月复发或进展的个体可以利用该治疗线有资格参加研究。 12 个月的时间分别从完成手术干预或铂类治疗开始计算。 这些人必须在转移性或局部晚期不可切除的情况下接受抗 PD-1/PD-L1 治疗才有资格。
- b.在新辅助/辅助环境中接受卡铂或抗 PD-1/PD-L1 治疗的个体将不能将该线治疗计入研究资格。
C。符合以下标准之一且在转移性或局部晚期不可切除环境中接受卡铂治疗的顺铂不合格个体可以将该治疗线计入资格。 然后他们必须在转移性或局部晚期不可切除的情况下接受抗 PD-1/PD-L1 治疗才有资格参加研究。
顺铂不合格被定义为满足以下标准之一：
- 1. 肌酐清除率 < 60 mL/min
- 2. ≥ 2 级听力损失
- 3.≥2级周围神经病变
- 4.纽约心脏协会（NYHA）III级心力衰竭
- 5.心电图PS≥2
- d.作为维持治疗的一部分进行的抗 PD-1/PD-L1 治疗可计入研究资格
- e.在先前的治疗线中接受 enfortumab vedotin 治疗后出现进展的个体，以及不符合条件或无法耐受 enfortumab vedotin 治疗的个体，有资格参加研究
- F。仅接受同步化放疗以保留膀胱而未接受进一步全身治疗的个体没有资格参加该研究。 卡铂替代顺铂不构成新方案，前提是方案中未添加新的化疗药物，并且在更换铂之前未发现进展。
- 先前接受过脑转移治疗的个体可以参加该研究，前提是他们在首次服用研究药物前至少 4 周内 CNS 疾病稳定并且所有神经系统症状稳定，没有新的或扩大的脑转移的证据，并且没有在研究药物首次给药前至少 7 天每天使用类固醇 >20 毫克泼尼松（或等效物）治疗脑转移。
- 研究药物开始后 2 周内无需输血或生长因子支持即可获得足够的血液学计数（血红蛋白 ≥ 9 g/dL，中性粒细胞绝对计数 (ANC) ≥1,500/mm^3，血小板≥100,000/µL）。
足够的肝功能（胆红素≤1.5x机构正常上限（IULN），天冬氨酸氨基转移酶（AST）和丙氨酸氨基转移酶（ALT）≤2.5xIULN或≤5xIULN，如果已知肝转移和血清白蛋白>3g/dL） .
对于总胆红素≤1 x IULN 且 AST 和/或 ALT ≤1.5x IULN（如果碱性磷酸酶也 >2.5 x IULN）的个体，多西紫杉醇将仅作为 TPC 组的选择。
- 通过 Cockcroft-Gault 方程或其他经过验证的仪器（例如， 肾脏疾病饮食修正 (MDRD) 方程）。
- 有生育能力的女性在接受首剂研究药物前 72 小时内的尿液或血清妊娠试验必须呈阴性。 如果尿检呈阳性或无法确认为阴性，则需要进行血清妊娠试验。
- 有生育能力的女性必须愿意使用 2 种节育方法或手术绝育或在研究期间至最后一次研究药物给药后 6 个月内戒除异性性行为。 有生育能力的个体是那些没有进行过手术绝育或没有月经超过 2 年的人。
- 男性必须同意从研究治疗的第一剂开始到最后一剂研究治疗后的 6 个月内使用适当的避孕方法。
关键排除标准：
- 怀孕或哺乳期的女性。
- 在第 1 周期第 1 天 (C1D1) 之前的 4 周内曾接受过抗癌单克隆抗体 (mAb)/抗体-药物偶联物 (ADC)，或者在周期 1 第 1 天 (C1D1) 之前的 2 周内曾接受过化疗、靶向小分子治疗或放射治疗到 C1D1。 参与观察性研究的个人有资格。
- 在对照组中接受过任何可用的 SOC 疗法的 UC 既往化疗（即，在长春氟宁未获批准治疗的地区既往接受过紫杉醇和多西紫杉醇，或在长春氟宁获批并上市销售的地区接受过紫杉醇、多西紫杉醇和长春氟宁） ).
由于先前施用的化疗剂，尚未从 AE 中恢复（即，≤ 1 级）。
- 注意：具有 ≤ 2 级神经病变或任何级别脱发的个体是该标准的例外，并且有资格参加研究。
- 注意：如果个人接受了大手术，他们必须在开始研究治疗之前从干预的毒性和/或并发症中充分恢复。
- 以前接受过拓扑异构酶 1 抑制剂。
患有活跃的第二恶性肿瘤。
• 注意：具有恶性肿瘤病史且在入组前 3 年没有活动性癌症证据的个体，或肿瘤经手术治愈且复发风险低的个体，在与研究人员讨论后允许入组。医疗监护仪。
患有活动性心脏病，定义为：
- C1D1 后 6 个月内发生心肌梗塞或不稳定型心绞痛。
- 严重室性心律失常（即室性心动过速或心室颤动）、高级别房室传导阻滞或其他需要抗心律失常药物治疗的心律失常病史（用抗心律失常药物控制良好的心房颤动除外）； QT间期延长史。
- NYHA III 级或更严重的充血性心力衰竭或左心室射血分数
- 入组后 6 个月内患有活动性慢性炎症性肠病（溃疡性结肠炎、克罗恩病）或胃肠道 (GI) 穿孔。
- 患有需要抗感染治疗的活动性严重感染（请联系医疗监测员进行澄清）。
- 已知人类免疫缺陷病毒 (HIV)-1/2 的病史，病毒载量无法检测，并且服用可能会干扰 SN-38 代谢的药物。
- 患有活动性乙型肝炎病毒 (HBV) 或丙型肝炎病毒 (HCV)。 在有 HBV 或 HCV 病史的个体中，将排除具有可检测病毒载量的个体。
- 有其他并发的医学或精神疾病，研究者认为这些疾病可能会混淆研究解释或妨碍研究程序和后续检查的完成。
- 不能耐受或对任何潜在的 TPC 剂或 sacituzumab govitecan-hziy 过敏，或者不能或不愿接受方案中规定的剂量。
- 出于任何原因无法完成所有指定的学习程序。
注意：其他协议定义的包含/排除标准可能适用。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Sacituzumab Govitecan-hziy (SG)
Participants will receive 10 mg/kg of SG intravenously (IV) on Day 1 and Day 8 of each 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion is met.
|
静脉内给药
其他名称：
|
|
有源比较器：Treatment of Physician's Choice
Participants will receive 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and will continue to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion is met. Paclitaxel 175 mg/m^2 IV on Day 1 of every 21-day cycle or Docetaxel 75 mg/m^2 IV on Day 1 of every 21-day cycle or Vinflunine 320 mg/m^2 IV on Day 1 of every 21-day cycle (in countries where vinflunine was approved and was commercially available). |
静脉内给药
其他名称：
静脉内给药
其他名称：
静脉内给药
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival (OS)
大体时间：Up to 42 months
|
OS was defined as time from the date of randomization to the date of death, regardless of cause.
Kaplan-Meier (KM) estimates were used for analysis.
|
Up to 42 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-Free Survival (PFS) by Investigator Assessment
大体时间：Up to 42 months
|
PFS was defined as the time from the date of randomization to the date of the first objectively documented disease progression (PD), per response evaluation criteria in solid tumors (RECIST) v1.1 criteria as determined by investigator assessment, or death regardless of cause, whichever occurs first.
PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
(Note: the appearance of one or more new lesions is also considered progression).
KM estimates were used for analysis.
|
Up to 42 months
|
|
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR)
大体时间：Up to 42 months
|
PFS is defined as the time from the date of randomization to the date of the first objectively documented disease progression (PD), per RECIST v1.1 criteria as determined by BICR, or death regardless of cause, whichever occurs first.
PD was defined in outcome measure (OM) #2.
KM estimates were used for analysis.
|
Up to 42 months
|
|
Objective Response Rate (ORR) by Investigator Assessment
大体时间：Up to 42 months
|
ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) as best overall response (BOR) as assessed by investigator assessment.
CR was defined as disappearance of all target lesions.
PR was defined as ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Percentages were rounded off.
|
Up to 42 months
|
|
Objective Response Rate (ORR) by BICR
大体时间：Up to 42 months
|
ORR was defined as the percentage of participants who achieved a CR or PR as BOR as assessed by BICR.
CR and PR are defined in OM#4.
Percentages were rounded off.
|
Up to 42 months
|
|
Clinical Benefit Rate (CBR) by Investigator Assessment
大体时间：Up to 42 months
|
CBR was defined as the percentage of participants who achieved a BOR of confirmed CR, PR, or stable disease (SD) for ≥ 6 months, per RECIST v1.1, as assessed by investigator assessment.
SD is defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started; PD was defined in OM#2; BOR, CR and PR are defined in OM#4.
Percentages were rounded off.
|
Up to 42 months
|
|
Clinical Benefit Rate (CBR) by BICR
大体时间：Up to 42 months
|
CBR was defined as the percentage of participants who achieved a BOR of confirmed CR, PR, or SD for ≥ 6 months, per RECIST v1.1, as assessed by BICR.
PD was defined in OM#2; BOR, CR and PR are defined in OM#4; SD was defined in OM#6.
Percentages were rounded off.
|
Up to 42 months
|
|
Duration of Objective Tumor Response (DOR) by Investigator Assessment
大体时间：Up to 42 months
|
DOR was defined as the time from the date when the criteria is first met for a CR or PR to the first date that PD is documented per RECIST 1.1 as determined by investigator assessment, or date of death, whichever occurs first.
KM estimates were used in analysis.
PD was defined in OM#2, CR and PR are defined in OM#4.
|
Up to 42 months
|
|
Duration of Objective Tumor Response (DOR) by BICR
大体时间：Up to 42 months
|
DOR was defined as the time from the date when the criteria is first met for a CR or PR to the first date that PD is documented per RECIST 1.1 as determined by BICR, or date of death, whichever occurs first.
KM estimates were used in analysis.
PD was defined in OM#2, CR and PR are defined in OM#4.
|
Up to 42 months
|
|
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
大体时间：From first dose up to 33.6 months
|
An adverse event (AE) was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution.
The SAE was defined as any untoward medical occurrence that at any dose which was fatal (results in death) or life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or an important medical event.
TEAEs were defined as an AE that onset in the period from the first dose of study treatment to 30 days after the last dose of study treatment.
Percentages were rounded off.
|
From first dose up to 33.6 months
|
|
Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities
大体时间：From first dose up to 33.6 months
|
A laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time of postbaseline up to and including the date of last study drug dose plus 30 days.
Severity grades were defined by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death.
Percentages were rounded off.
|
From first dose up to 33.6 months
|
|
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score
大体时间：Baseline (Day 0)
|
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items.
Domain scores were reported for following scales: Physical Functioning, Global Health Status, Pain, and Fatigue Score.
Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual.
All of the scales and single-item measures range in score from 0 to 100.
Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).
For Symptom scales, a lower score means better quality of life.
For Global Health Status and Functional Scales, a higher score signifies better quality of life.
|
Baseline (Day 0)
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score
大体时间：Cycle 5 Day 1; Cycle length = 21 days
|
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items.
Domain scores were reported for following scales: Physical Functioning, Global Health Status, Pain, and Fatigue Score.
Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual.
All of the scales and single-item measures range in score from 0 to 100.
Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).
For Symptom scales, a lower score means better quality of life.
For Global Health Status and Functional Scales, a higher score signifies better quality of life.
|
Cycle 5 Day 1; Cycle length = 21 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Powles T, Tagawa S, Vulsteke C, Gross-Goupil M, Park SH, Necchi A, De Santis M, Duran I, Morales-Barrera R, Guo J, Sternberg CN, Bellmunt J, Goebell PJ, Kovalenko M, Boateng F, Sierecki M, Wang L, Sima CS, Waldes J, Loriot Y, Grivas P. Sacituzumab govitecan in advanced urothelial carcinoma: TROPiCS-04, a phase III randomized trial. Ann Oncol. 2025 May;36(5):561-571. doi: 10.1016/j.annonc.2025.01.011. Epub 2025 Feb 11.
- Grivas P, Tagawa S, Bellmunt J, De Santis M, Duran I, Goebell PJ, et al. TROPiCS-04: Study of Sacituzumab Govitecan in Metastatic or Locally Advanced Unresectable Urothelial Cancer That Has Progressed After Platinum and Checkpoint Inhibitor Therapy. [Poster TPS498]. American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU); 2021 February 11-13; Virtual meeting.
- Grivas P., Powles T., Vulsteke C., Gross-Goupil M., Park S. et al. LBA9 TROPiCS-04, a randomized phase III study of sacituzumab govitecan (SG) vs chemotherapy (CT) in pretreated advanced urothelial carcinoma (aUC): Overall survival (OS) and safety analysis. Annals of Oncology, Volume 35, Supplement 4, S1505-S1507, December 2024.
- Vulsteke C, Grivas P, Tagawa ST, Bellmunt J, De Santis M, Duran I, et al. TROPiCS-04: Study of Sacituzumab Govitecan (SG) in Patients (Pts) With Locally Advanced (LA) Unresectable or M etastatic Urothelial Cancer (mUC) That Has Progressed After Prior Platinum (PLT) and Checkpoint Inhibitor (CPI) Therapy. [Poster TPS582]. American Society of Clinical Oncology Genitourinary (ASCO-GU); 2022 February 17-19; Annual Meeting.
- Powles T, Tagawa ST, Vulsteke C, Gross-Goupil M, Park SH, Necchi A, De Santis M, Duran I, Morales-Barrera R, Guo J, Sternberg CN, Bellmunt J, Goebell PJ, Kovalenko M, Boateng F, Sierecki M, Wang L, Sima CS, Waldes J, Bangs R, Loriot Y, Grivas P. A plain language summary of the TROPiCS-04 study: sacituzumab govitecan use after platinum-based chemotherapy and immunotherapy in people with locally advanced or metastatic cancer of the bladder, urethra, or upper urinary tract. Future Oncol. 2025 Dec;21(28):3593-3610. doi: 10.1080/14796694.2025.2579003. Epub 2025 Nov 23.
- Klumper N, Cox A, Sjodahl G, Roghmann F, Bolenz C, Hartmann A, Grunwald V, Faltas BM, Holzel M, Eckstein M. Pre-treatment metastatic biopsy: a step towards precision oncology for urothelial cancer. Nat Rev Urol. 2025 May;22(5):256-267. doi: 10.1038/s41585-024-00951-2. Epub 2024 Oct 29.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年1月13日
初级完成 (实际的)
2025年7月4日
研究完成 (实际的)
2025年7月4日
研究注册日期
首次提交
2020年8月19日
首先提交符合 QC 标准的
2020年8月22日
首次发布 (实际的)
2020年8月27日
研究记录更新
最后更新发布 (实际的)
2026年6月2日
上次提交的符合 QC 标准的更新
2026年5月6日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IMMU-132-13
- 2024-513870-23 (其他标识符：European Medicines Agency)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.