此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Is Prolonged Systemic Immunotherapy Necessary After Achieving Tumor-free Status in Patients With Extensive Transurethrally Unresectable Very-high-risk NMIBC?

2026年5月28日 更新者：Tianjin Medical University Second Hospital

Randomized Trial of Active Surveillance Versus Continued Systemic Immunotherapy After Achieving Tumor-Free Status in Extensive Transurethrally Unresectable Very-High-Risk NMIBC

Patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC) may achieve a tumor-free status after systemic immunotherapy-based bladder-sparing treatment combined with transurethral resection of bladder tumor (TURBT). However, the optimal duration of systemic immunotherapy after achieving a tumor-free status remains uncertain. Prolonged treatment may increase toxicity, treatment burden, and cost, while some patients may maintain durable disease control without continued therapy.

This randomized study aims to evaluate whether active surveillance after achieving tumor-free status is a feasible alternative to continued systemic immunotherapy in patients with extensive transurethrally unresectable very-high-risk NMIBC.

Patients will initially receive systemic immunotherapy-based treatment followed by disease evaluation using cystoscopy with biopsy and/or TURBT, urine cytology, urinary tumor DNA (utDNA), and imaging assessments. Patients who achieve tumor-free status after treatment and complete resection of visible disease will be randomized to either active surveillance or continued systemic immunotherapy.

The study will evaluate recurrence outcomes, bladder preservation, progression, safety, and patient management strategies following achievement of tumor-free status. The trial also aims to explore the role of urinary tumor DNA in identifying patients who may safely undergo treatment de-escalation and active surveillance.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

120

阶段

  • 阶段2

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。

学习联系方式

研究联系人备份

学习地点

  • 中国
      • Tianjin、中国
        • General Hospital of Tianjin Medical University
        • 接触：
      • Tianjin、中国、300000
        • The Second Hospital of Tianjin Medical University
        • 接触：
      • Tianjin、中国
        • Tianjin Hospital
        • 接触：
      • Xingtai、中国
        • Xingtai People's Hospital
        • 接触：

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria

  • Has histologically confirmed very-high-risk non-muscle-invasive urothelial carcinoma of the bladder.
  • Has transurethrally unresectable bladder tumor, defined as visually incomplete TURBT and/or extensive high-volume disease considered unsuitable for complete and oncologically adequate transurethral resection.
  • Has undergone cystoscopy and TURBT evaluation before study enrollment.
  • Has received systemic PD-1/PD-L1 inhibitor-based bladder-sparing therapy before randomization.

  • Has achieved tumor-free status before randomization, defined as:

    1. No visible bladder tumor on cystoscopy;
    2. Negative bladder biopsy and/or TURBT pathology;
    3. Negative urine cytology;
    4. Negative urinary tumor DNA (utDNA);
    5. No radiographic evidence of progression or metastasis.
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Has adequate organ function.
  • Has provided written informed consent.

Cohort A Only

  • Achieved tumor-free status at the initial response evaluation after induction systemic therapy.
  • Maintained tumor-free status after additional systemic therapy before randomization.

Cohort B Only

  • Did not achieve tumor-free status at the initial response evaluation because of residual non-muscle-invasive disease.
  • Subsequently underwent complete TURBT/resection of residual disease followed by additional systemic therapy.
  • Achieved tumor-free status at the second response evaluation before randomization.

Exclusion Criteria

  • Has muscle-invasive bladder cancer (≥T2), locally advanced unresectable disease, nodal disease, or distant metastasis.
  • Has concurrent upper tract urothelial carcinoma.
  • Has persistent visible tumor, positive bladder pathology, positive urine cytology, or positive utDNA before randomization.
  • Has received prior systemic immunotherapy for metastatic urothelial carcinoma.
  • Has active autoimmune disease requiring systemic treatment.
  • Is receiving systemic immunosuppressive therapy.
  • Has uncontrolled infection requiring systemic therapy.
  • Has another active malignancy requiring systemic treatment.
  • Has known active hepatitis B, hepatitis C, human immunodeficiency virus infection, or active tuberculosis.
  • Has pregnancy or breastfeeding.
  • Has any medical or psychiatric condition that, in the investigator's judgment, would interfere with study participation or interpretation of results.

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：Arm A-1 (Cohort A Active Surveillance)
Patients in Cohort A who achieve early tumor-free status after initial systemic immunotherapy-based treatment will undergo active surveillance with protocol-defined cystoscopy, urine cytology, urinary tumor DNA testing, biopsy as clinically indicated, and imaging assessments.
行为的：Active Surveillance
Patients undergo protocol-defined surveillance after achieving tumor-free status, including cystoscopy, biopsy as clinically indicated, urine cytology, urinary tumor DNA testing, and imaging assessments, without continued systemic PD-1/PD-L1 inhibitor therapy unless disease recurrence or progression occurs.
有源比较器：Arm A-2 (Cohort A Continued Systemic Immunotherapy)
Patients in Cohort A who achieve early tumor-free status after initial systemic immunotherapy-based treatment will continue systemic immunotherapy for a protocol-defined duration with ongoing disease surveillance.
药品：PD-1/PD-L1 Inhibitor-Based Systemic Immunotherapy
Patients continue protocol-defined systemic PD-1/PD-L1 inhibitor therapy after achieving tumor-free status for up to approximately 1 year, with ongoing surveillance including cystoscopy, urine cytology, urinary tumor DNA testing, and imaging assessments.
实验性的：Arm B-1 (Cohort B Active Surveillance)
Patients in Cohort B who do not achieve tumor-free status at initial evaluation but subsequently achieve tumor-free status after complete TURBT/resection and additional systemic immunotherapy will undergo active surveillance with protocol-defined surveillance assessments.
行为的：Active Surveillance
Patients undergo protocol-defined surveillance after achieving tumor-free status, including cystoscopy, biopsy as clinically indicated, urine cytology, urinary tumor DNA testing, and imaging assessments, without continued systemic PD-1/PD-L1 inhibitor therapy unless disease recurrence or progression occurs.
有源比较器：Arm B-2 (Cohort B Continued Systemic Immunotherapy)
Patients in Cohort B who subsequently achieve tumor-free status after complete TURBT/resection and additional systemic immunotherapy will continue systemic immunotherapy for a protocol-defined duration with ongoing disease surveillance.
药品：PD-1/PD-L1 Inhibitor-Based Systemic Immunotherapy
Patients continue protocol-defined systemic PD-1/PD-L1 inhibitor therapy after achieving tumor-free status for up to approximately 1 year, with ongoing surveillance including cystoscopy, urine cytology, urinary tumor DNA testing, and imaging assessments.

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
Bladder-intact event-free survival (BI-EFS)
大体时间：Up to 2 years from randomization
Time from randomization to the first occurrence of high-risk NMIBC recurrence, progression to muscle-invasive bladder cancer, distant metastasis, radical cystectomy, or death from any cause.
Up to 2 years from randomization

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 2 years from randomization
Time from randomization to the first documented recurrence of bladder cancer or death from any cause.
Up to 2 years from randomization
Progression-free survival (PFS)
大体时间：Up to 2 years from randomization
Time from randomization to progression to muscle-invasive, locally advanced, or metastatic bladder cancer, or death from any cause.
Up to 2 years from randomization
Radical cystectomy-free survival (RCFS)
大体时间：Up to 2 years from randomization
Time from randomization to radical cystectomy or death from any cause.
Up to 2 years from randomization
Overall survival (OS)
大体时间：Up to 2 years from randomization
Time from randomization to death from any cause.
Up to 2 years from randomization
Incidence of treatment-related adverse events
大体时间：Up to 2 years from randomization
Proportion of patients experiencing treatment-related adverse events, graded according to CTCAE.
Up to 2 years from randomization

其他结果措施

结果测量
措施说明
大体时间
Recurrence-Free Survival According to Urinary Tumor DNA Status
大体时间：Up to 2 years from randomization
Recurrence-free survival will be evaluated according to urinary tumor DNA status after achieving tumor-free status. Urinary tumor DNA status will be assessed using a urine-based tumor DNA assay and categorized as positive or negative.
Up to 2 years from randomization
utDNA conversion during surveillance
大体时间：Up to 2 years from initial systemic administration
Proportion of patients with conversion from urinary tumor DNA negative to positive during follow-up.
Up to 2 years from initial systemic administration
Bladder-Intact Event-Free Survival According to Response Cohort in the Active Surveillance Arm
大体时间：Up to 2 years from randomization
Bladder-intact event-free survival will be compared between participants assigned to active surveillance in Cohort A and Cohort B.
Up to 2 years from randomization
Recurrence-Free Survival According to Response Cohort in the Active Surveillance Arm
大体时间：Up to 2 years from randomization
Recurrence-free survival will be compared between participants assigned to active surveillance in Cohort A and Cohort B.
Up to 2 years from randomization
Bladder-Intact Event-Free Survival According to Response Cohort in the Continued Systemic Immunotherapy Arm
大体时间：Up to 2 years from randomization
Bladder-intact event-free survival will be compared between participants assigned to continued systemic immunotherapy in Cohort A and Cohort B.
Up to 2 years from randomization
Recurrence-Free Survival According to Response Cohort in the Continued Systemic Immunotherapy Arm
大体时间：Up to 2 years from randomization
Recurrence-free survival will be compared between participants assigned to continued systemic immunotherapy in Cohort A and Cohort B.
Up to 2 years from randomization

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

Tianjin Medical University Second Hospital

调查人员

  • 首席研究员：Hailong Hu, MD、Department of Urology, The Second Hospital of Tianjin Medical University

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 (估计的)

2026年5月30日

初级完成 (估计的)

2029年3月30日

研究完成 (估计的)

2032年5月30日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年5月28日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年6月4日

上次提交的符合 QC 标准的更新

2026年5月28日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Truce-LB03

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 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

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.

订阅