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

2026년 5월 28일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

120

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 중국
      • Tianjin, 중국
        • General Hospital of Tianjin Medical University
        • 연락하다:
      • Tianjin, 중국, 300000
        • The Second Hospital Of Tianjin Medical University
        • 연락하다:
      • Tianjin, 중국
        • Tianjin Hospital
        • 연락하다:
      • Xingtai, 중국
        • Xingtai People's Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: 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.
활성 비교기: 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.
의약품: 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.
실험적: 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.
행동: 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.
활성 비교기: 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.
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Bladder-intact event-free survival (BI-EFS)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Recurrence-free survival (RFS)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: Up to 2 years from randomization
Proportion of patients experiencing treatment-related adverse events, graded according to CTCAE.
Up to 2 years from randomization

기타 결과 측정

결과 측정
측정값 설명
기간
Recurrence-Free Survival According to Urinary Tumor DNA Status
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Tianjin Medical University Second Hospital

수사관

  • 수석 연구원: Hailong Hu, MD, Department of Urology, The Second Hospital of Tianjin Medical University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 30일

기본 완료 (추정된)

2029년 3월 30일

연구 완료 (추정된)

2032년 5월 30일

연구 등록 날짜

최초 제출

2026년 5월 21일

QC 기준을 충족하는 최초 제출

2026년 5월 28일

처음 게시됨 (실제)

2026년 6월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 28일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Truce-LB03

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Active Surveillance에 대한 임상 시험

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스폰서 및 공동 작업자

건강 상태

약물 개입

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다