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

28. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

120

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
      • Tianjin, Kina
        • General Hospital of Tianjin Medical University
        • Ta kontakt med:
      • Tianjin, Kina, 300000
        • The Second Hospital of Tianjin Medical University
        • Ta kontakt med:
      • Tianjin, Kina
        • Tianjin Hospital
        • Ta kontakt med:
      • Xingtai, Kina
        • Xingtai People's Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Aktiv komparator: 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.
Legemiddel: 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.
Eksperimentell: 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.
Atferdsmessig: 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.
Aktiv komparator: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bladder-intact event-free survival (BI-EFS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recurrence-free survival (RFS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Up to 2 years from randomization
Proportion of patients experiencing treatment-related adverse events, graded according to CTCAE.
Up to 2 years from randomization

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recurrence-Free Survival According to Urinary Tumor DNA Status
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tianjin Medical University Second Hospital

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. mai 2026

Primær fullføring (Antatt)

30. mars 2029

Studiet fullført (Antatt)

30. mai 2032

Datoer for studieregistrering

Først innsendt

21. mai 2026

Først innsendt som oppfylte QC-kriteriene

28. mai 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Truce-LB03

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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