NCT07475403

Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer

A Prospective Study of Urinary Tumor DNA-Guided Systemic Immunotherapy in Patients With Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate whether urinary tumor DNA (utDNA) can guide treatment duration in patients with unresectable very-high-risk non-muscle-invasive bladder cancer (VHR NMIBC) who achieve complete clinical response after systemic immunotherapy. Participants will receive systemic immunotherapy followed by response assessment using pathology, cystoscopy, urine cytology, and utDNA testing. Patients who achieve complete clinical response will receive a short additional course of immunotherapy before stopping treatment according to the study protocol. The study hypothesizes that a shortened duration of systemic immunotherapy guided by utDNA monitoring may maintain favorable oncologic outcomes in this population.

Conditions

• Bladder Cancer
• Liquid Biopsy
• Immunotherapy

Interventions

Type	Name	Description
DRUG	Systemic immunotherapy	Participants receive systemic immune checkpoint inhibitor therapy administered intravenously every 3 weeks for an initial 3 cycles. Treatment response is then evaluated using transurethral resection of bladder tumor (TURBT) pathology, cystoscopy with biopsy, urinary tumor DNA (utDNA), and urine cytology. Patients achieving complete clinical response (cCR), defined as negative pathology, negative utDNA, and negative urine cytology, receive an additional 3 cycles of systemic immunotherapy. Treatment is subsequently discontinued if repeat evaluation confirms sustained cCR. Patients who do not meet the cCR criteria continue clinical management and follow-up according to institutional practice.

Timeline

• Start date: 2026-03-16
• Primary completion: 2028-04-01
• Completion: 2029-04-01
• First posted: 2026-03-16
• Last updated: 2026-03-30

Locations

1 site across 1 country: China