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卡介苗 (BCG) 治疗后复发性高风险非肌肉浸润性膀胱癌 (HR-NMIBC) 受试者中 TAR-200 与膀胱内化疗的研究 (SunRISe-5)

2026年11月2日 更新者：Janssen Research & Development, LLC

一项 3 期、随机、开放标签、多中心研究，评估 TAR-200 与研究者选择的膀胱内化疗的疗效和安全性，这些研究对象接受了卡介苗 (BCG) 并患有高危非肌肉疾病复发。浸润性膀胱癌 (HR-NMIBC) 以及不适合或不选择接受根治性膀胱切除术的人群

The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

272

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

  • 中国
      • Beijing、中国、100034
        • Peking University First Hospital
      • Cheng Du Shi、中国、610041
        • West China School of Medicine/West China Hospital, Sichuan University
      • Chongqing、中国、400033
        • Chongqing Cancer Hospital
      • Guangzhou、中国、510060
        • Sun Yat Sen University Cancer Center
      • Shenyang、中国、110055
        • Shengjing Hospital Of China Medical University
      • Tianjin、中国、300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin、中国、300211
        • The Second Hospital Of Tianjin Medical University
      • Wenzhou、中国、325015
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan、中国、430032
        • Tongji Medical College of Huazhong University Science Technology of Medicine Health Management
      • Xi'an、中国、710063
        • Xi an Jiaotong University Hospital
  • 巴西
      • Barretos、巴西、14784-400
        • Fundacao Pio XII
      • Bauru、巴西、17030-495
        • NAIC Nair Antunes Instituto do Cancer
      • Campinas、巴西、13083-872
        • Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
      • Curitiba、巴西、81520-060
        • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
      • Porto Alegre、巴西、90020-090
        • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Salvador、巴西、41810-011
        • Hospital da Bahia
      • São Paulo、巴西、01308 901
        • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
      • São Paulo、巴西、01509 900
        • Fundacao Antonio Prudente A C Camargo Cancer Center
      • São Paulo、巴西、01323 900
        • Real e Benemérita Associação Portuguesa de Beneficência
  • 德国
      • Cologne、德国、50937
        • Universitaetsklinikum Koeln
      • Halle、德国、06120
        • Universitaetsklinikum Halle Saale
      • Leverkusen、德国、51375
        • Klinikum Leverkusen gGmbH
      • Lübeck、德国、23538
        • Universitatsklinikum Schleswig Holstein Campus Lubeck
      • Mettmann、德国、40822
        • Urologie Neandertal Praxis Mettmann
      • München、德国、81377
        • Klinikum der Universitaet Muenchen
  • 意大利
      • Arezzo、意大利、52100
        • Ospedale San Donato
      • Milan、意大利、20132
        • San Raffaele Hospital
      • Milan、意大利、20133
        • Istituto Dei Tumori Di Milano
      • Province of Macerata、意大利、62100
        • Ospedale Provinciale di Macerata
      • Ravenna、意大利、48121
        • Ospedale S. Maria Delle Croci
      • Roma、意大利、00144
        • Istituto Nazionale Tumori Regina Elena
      • Roma、意大利、00128
        • Universita Campus Bio-Medico di Roma
      • Rozzano、意大利、20089
        • Istituto Clinico Humanitas
      • Torino、意大利、10126
        • PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
  • 日本
      • Funabashi Shi、日本、273 8588
        • Funabashi Municipal Medical Center
      • Hakodate、日本、040 8611
        • Hakodate Goryoukaku Hospital
      • Hyōgo、日本、660-8550
        • Hyogo Prefectural Amagasaki General Medical Center
      • Niigata、日本、951-8566
        • Niigata Cancer Center Hospital
      • Okayama、日本、701-1192
        • National Hospital Organization Okayama Medical Center
      • Sakura、日本、285-8741
        • Toho University Sakura Medical Center
      • Tokyo、日本、105-8470
        • Toranomon Hospital
      • Yokohama、日本、232 0024
        • Yokohama City University Medical Center
  • 比利时
      • Bruges、比利时、8000
        • AZ Sint-Jan
      • Brussels、比利时、1200
        • Cliniques Universitaires Saint Luc
      • Genk、比利时、3600
        • Ziekenhuis Oost-Limburg
      • Ghent、比利时、9000
        • Algemeen ziekenhuis Maria Middelares
      • Roeselare、比利时、8800
        • Algemeen Ziekenhuis Delta
  • 法国
      • Lille、法国、59000
        • Hopital Claude Huriez
      • Limoges、法国、87000
        • Polyclinique de Limoges - Francois Chenieux
      • Marseille、法国、13009
        • Institut Paoli Calmettes
      • Paris、法国、75018
        • APHP - Hopital Bichat - Claude Bernard
      • Quint-Fonsegrives、法国、31130
        • Clinique de la Croix du Sud
      • Rennes、法国、35000
        • Chu Rennes Hopital Pontchaillou
      • Suresnes、法国、92150
        • Hopital Foch
  • 波兰
      • Bialystok、波兰、15 276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Bydgoszcz、波兰、85 048
        • IN VIVO Sp. z o.o
      • Krakow、波兰、30 688
        • Szpital Uniwersytecki w Krakowie
      • Lublin、波兰、20 090
        • Uniwersytecki Szpital Kliniczny nr 4
      • Przemyśl、波兰、37 700
        • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
      • Tarnów、波兰、33 100
        • Szpital Wojewodzki im Sw Lukasza SP ZOZ
      • Torun、波兰、87-100
        • MICS Centrum Medyczne Torun
      • Wieliszew、波兰、05-135
        • Mazowiecki Szpital Onkologiczny
      • Wroclaw、波兰、53 413
        • Dolnoslaskie Centrum Onkologii
  • 罗马尼亚
      • Brasov、罗马尼亚、500091
        • Centrul Medical Unirea SRL
      • Bucharest、罗马尼亚、014142
        • Ponderas Academic Hospital
      • Cluj-Napoca、罗马尼亚、400015
        • Institutul Oncologic Ion Chiricuta
      • Cluj-Napoca、罗马尼亚、400117
        • Regina Maria
      • Timișoara、罗马尼亚、300723
        • Spitalul Clinic Judetean de Urgenta Pius Brinzeu
  • 美国
    • Arkansas
      • Little Rock、Arkansas、美国、72211
        • Arkansas Urology
    • California
      • Los Alamitos、California、美国、90720
        • Genesis Research LLC 1
      • Los Angeles、California、美国、90033
        • USC Norris Comprehensive Cancer Center
      • Orange、California、美国、92868
        • University of California Irvine Medical Center
      • San Francisco、California、美国、94158 2549
        • University of California San Francisco
      • Torrance、California、美国、90503
        • Genesis Research LLC
    • Colorado
      • Lakewood、Colorado、美国、80228
        • Colorado Clinical Research
    • Florida
      • Riverview、Florida、美国、33578
        • Florida Urology Partners
    • Illinois
      • Chicago、Illinois、美国、60611
        • Northwestern University
      • Chicago Ridge、Illinois、美国、60415
        • UroPartners
    • Indiana
      • Carmel、Indiana、美国、46032
        • Urology of Indiana
      • Jeffersonville、Indiana、美国、47130
        • First Urology, PSC
    • Kansas
      • Wichita、Kansas、美国、67226
        • Wichita Urology Group
    • Michigan
      • Royal Oak、Michigan、美国、48073
        • Comprehensive Urology
    • Missouri
      • St Louis、Missouri、美国、63141
        • Specialty Clinical Research of St Louis
    • New York
      • Syracuse、New York、美国、13210
        • Associated Medical Professionals
    • Ohio
      • Cincinnati、Ohio、美国、45212
        • The Urology Group
      • Gahanna、Ohio、美国、43230
        • Central Ohio Urology Group
    • Pennsylvania
      • Bala-Cynwyd、Pennsylvania、美国、19004
        • Centers for Advanced Urology LLC d b a MidLantic Urology
    • South Carolina
      • Charleston、South Carolina、美国、29401
        • Ralph H. Johnson Veterans Affairs Medical Center
      • Myrtle Beach、South Carolina、美国、29572
        • Carolina Urologic Research Center
      • North Charleston、South Carolina、美国、29406
        • Low Country Urology Clinics
    • Tennessee
      • Nashville、Tennessee、美国、37232
        • Vanderbilt University Medical Center
      • Nashville、Tennessee、美国、37209
        • Urology Associates
    • Texas
      • Austin、Texas、美国、78759
        • Urology Austin
      • Dallas、Texas、美国、75390
        • University of Texas Southwestern Medical Center
      • Dallas、Texas、美国、75231
        • Urology Clinics of North Texas
      • Houston、Texas、美国、77027
        • Houston Metro Urology
    • Washington
      • Spokane、Washington、美国、99202
        • Spokane Urology
  • 英国
      • London、英国、EC1A 7BE
        • St Bartholomews Hospital
      • Salford、英国、M6 8HD
        • Salford Royal Hospital
      • Southampton、英国、SO16 6YD
        • Southampton University Hospital
      • Stevenage、英国、SG1 4AB
        • Lister Hospital
  • 西班牙
      • Badalona、西班牙、08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona、西班牙、08025
        • Fund. Puigvert
      • Madrid、西班牙、28041
        • Hosp. Univ. 12 de Octubre
      • Madrid、西班牙、28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Málaga、西班牙、29010
        • Hosp Virgen de La Victoria
      • Sabadell、西班牙、08208
        • Hosp.Univ.Parc Tauli
      • Santander、西班牙、39008
        • Hosp. Univ. Marques de Valdecilla
      • Seville、西班牙、41013
        • Hosp. Virgen Del Rocio
      • Valencia、西班牙、46010
        • Hosp. Clinico Univ. de Valencia
  • 阿根廷
      • Buenos Aires、阿根廷、C1406
        • Clinica Santa Isabel
      • CABA、阿根廷、C1425
        • Investigaciones Clinico Moleculares (ICM)
      • Córdoba、阿根廷、5000
        • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
      • Córdoba、阿根廷、X5000KPH
        • Centro Urologico Profesor Bengio
      • Mar del Plata、阿根廷、B7602
        • Hospital Privado de la Comunidad
  • 韩国
      • Chungcheongbuk Do、韩国、28644
        • Chungbuk National University Hospital
      • Daegu、韩国、42601
        • Keimyung University Dongsan Hospital
      • Gyeonggi-do、韩国、10408
        • National Cancer Center
      • Jeollanam-do、韩国、58128
        • Chonnam National University Hwasun Hospital
      • Seoul、韩国、03080
        • Seoul National University Hospital
      • Seoul、韩国、06351
        • Samsung Medical Center
      • Seoul、韩国、06591
        • The Catholic University of Korea Seoul St Mary s Hospital
      • Yangsan、韩国、50612
        • Pusan National University Yangsan Hospital

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [defined as high-grade Ta or any T1, no carcinoma in situ (CIS)]
  • Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded
  • Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2

Exclusion Criteria:

  • Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, N+, and/or M+)
  • Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200. Participants with tumors involving the prostatic urethra in men will be excluded
  • A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (>4000 mL)
  • Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
  • Previous treatment with TAR-200

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：Group A: TAR-200

Participants will receive intravesical TAR-200 every 3 weeks during an induction phase and every 12 weeks during a maintenance phase.
药品：TAR-200

Participants will receive TAR-200 intravesically.

其他名称：
  • JNJ-17000139
有源比较器：Group B: Mitomycin C (MMC) or Gemcitabine

Participants will receive either single agent intravesical MMC or gemcitabine every week during an induction phase and every 4 weeks during a maintenance phase.
药品：Mitomycin C

Participants will receive MMC intravesically.

药品：Gemcitabine

Participants will receive gemcitabine intravesically.

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
Disease-free Survival (DFS)
大体时间：Up to 6 years 7 months

DFS will be measured as the time from randomization to the time of the first recurrence of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [high grade (HG) Ta, any T1 or carcinoma in situ (CIS)], progression, or death due to any cause, whichever occurs first.
Up to 6 years 7 months

次要结果测量

结果测量
措施说明
大体时间
Recurrence-Free Survival (RFS)
大体时间：Up to 6 years 7 months

RFS will be measured as the time from randomization to the time of the first recurrence of HR-NMIBC (HG Ta, any T1 or CIS), or death due to any cause, whichever occurs first.
Up to 6 years 7 months
Time to Next Intervention (TTNI)
大体时间：Up to 6 years 7 months

TTNI will be measured as the time from randomization to the time of next intervention (localized or systemic) for the treatment of bladder cancer.
Up to 6 years 7 months
Time to Disease Worsening (TTDW)
大体时间：Up to 6 years 7 months

TTDW is measured as the time from randomization to cystectomy, systemic therapy, or radiation therapy (treatments of disease worsening).
Up to 6 years 7 months
Time to Progression (TTP)
大体时间：Up to 6 years 7 months

TTP will be measured as the time from randomization to the time of first documented evidence of disease progression (that is, progression to muscle-invasive bladder cancer [MIBC] [T greater than or equal to {>=} 2], lymph node disease [N+], or distant disease [M+]), or death due to disease progression, whichever occurs first.
Up to 6 years 7 months
Overall Survival (OS)
大体时间：Up to 6 years 7 months

OS is defined as the time from randomization to death, due to any cause.
Up to 6 years 7 months
DFS Rate at 12 and 24 Months
大体时间：At 12 and 24 months

DFS rate that is percentage of participants with DFS at 12 and 24 months will be reported.
At 12 and 24 months
Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)
大体时间：Up to 6 years 7 months

Number of participants with AEs by severity grade as assessed by CTCAE version 5 will be reported. Grade refers to the severity of AE as follows: Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5- Death related to adverse event.
Up to 6 years 7 months
Number of Participants With Change from Baseline in Laboratory Abnormalities
大体时间：Up to 6 years 7 months

Number of participants with change from baseline in laboratory abnormalities (including hematology, clinical chemistry and routine urinalysis) will be reported.
Up to 6 years 7 months
Number of Participants With Change from Baseline in Vital Signs Abnormalities
大体时间：Up to 6 years 7 months

Number of participants with change from baseline in vital signs including temperature, pulse/heart rate, respiratory rate, and blood pressure (systolic and diastolic) (supine) will be reported.
Up to 6 years 7 months
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) - C30 Scores
大体时间：Up to 5 years

EORTC QLQ-C30 is a 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much).
Up to 5 years
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
大体时间：Up to 5 years

EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with NMIBC. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales (urinary symptoms, malaise, future worries, bloating and flatulence, sexual function and male sexual problems) and 5 single items (intravesical treatment issues, sexual intimacy, worries about risk of contaminating partner, sexual enjoyment, and female sexual problems). Ratings for each item range from 1 (not at all) to 4 (very much).
Up to 5 years
Proportion of Participants With Meaningful Change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 Scores
大体时间：Up to 5 years

Proportion of participants with meaningful change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 scores will be reported.
Up to 5 years

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。

赞助

Janssen Research & Development, LLC

调查人员

  • 研究主任：Janssen Research & Development, LLC Clinical trial、Janssen Research & Development, LLC

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)

2024年4月9日

初级完成 (估计的)

2030年11月27日

研究完成 (估计的)

2031年4月14日

研究注册日期

首次提交

2024年1月9日

首先提交符合 QC 标准的

2024年1月9日

首次发布 (实际的)

2024年1月18日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11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

  • 17000139BLC3004
  • 17000139BLC3004 (其他标识符：Janssen Research & Development, LLC)
  • 2023-507685-10-00 (注册表标识符：EUCT number)
  • 2023 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

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

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.

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