Using urinary tumor DNA to guide how long systemic immunotherapy is given for unresectable very‑high‑risk non‑muscle‑invasive bladder cancer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 2 interventional trial, participants with unresectable very‑high‑risk non‑muscle‑invasive bladder cancer receive systemic immunotherapy and undergo response checks using cystoscopy, biopsy/pathology, urine cytology, and urinary tumor DNA (utDNA) testing. Patients who achieve a complete clinical response receive a short additional course of immunotherapy and then stop treatment according to the protocol while utDNA is used to guide timing. Oncologic outcomes and recurrence will be monitored clinically and with molecular testing. The study aims to see if utDNA-guided shortening of systemic immunotherapy can preserve cancer control while reducing treatment exposure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years.
2. Histologically confirmed non-muscle-invasive urothelial carcinoma of the bladder classified as very-high-risk (VHR) according to EAU 2025 guideline criteria.
3. Disease considered unresectable by the investigator and multidisciplinary team, defined as complete tumor eradication by standard transurethral resection of bladder tumor (TURBT) being not feasible or unlikely to achieve adequate local control.
4. Patients who are ineligible or refuse for radical cystectomy, after discussion with the treating team.
5. At least one measurable or evaluable bladder lesion/documented residual disease suitable for response assessment by cystoscopy, TURBT/biopsy, pathology, urine cytology, and urinary tumor DNA (utDNA) testing.
6. ECOG performance status 0-2.
7. Adequate organ function, including:

   Hematologic function: Absolute neutrophil count ≥1.5 × 10⁹/L, Platelet count ≥100 × 10⁹/L, Hemoglobin ≥9 g/dL Hepatic function: Total bilirubin ≤1.5 × ULN, AST ≤2.5 × ULN, ALT ≤2.5 × ULN Renal function: Serum creatinine ≤1.5 × ULN or Creatinine clearance ≥60 mL/min.
8. Ability to provide urine samples for utDNA testing and urine cytology during treatment and follow-up.

Exclusion Criteria:

1. Muscle-invasive bladder cancer (≥T2), locally advanced unresectable invasive disease beyond NMIBC, or metastatic urothelial carcinoma at baseline.
2. Histology showing predominant or pure non-urothelial carcinoma of the bladder that, in the investigator's judgment, would make the patient unsuitable for this protocol.
3. Prior treatment with immune.
4. Active autoimmune disease or history of autoimmune disease requiring systemic immunosuppressive treatment and considered incompatible with immune checkpoint inhibitor therapy.
5. Ongoing systemic immunosuppressive therapy exceeding protocol-allowed doses.

7\. Active uncontrolled infection, including uncontrolled urinary tract infection, that would interfere with study treatment or response assessment.

8\. Any medical condition that would preclude safe administration of systemic immunotherapy or protocol-required cystoscopy/TURBT/biopsy, in the investigator's judgment.

9\. Concurrent other malignancy. 10. Pregnant or breastfeeding women. 11. Inability to comply with protocol procedures or follow-up.

Where it's running

• The Second Hospital of Tianjin Medical University
  Tianjin, China Recruiting
• Tianjin Hospital
  Tianjin, China Recruiting
• Xingtai People's Hospital
  Xingtai, China Recruiting

Study contacts

• Study coordinator: Hailong Hu
• Email: huhailong@tmu.edu.cn
• Phone: +8619801518556

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.