RecruitingPhase 2NCT07475403

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

Sponsor

Tianjin Medical University Second Hospital

Enrollment

53 participants

Start Date

Mar 16, 2026

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer Immunotherapy Liquid Biopsy

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an immunotherapy approach for people with a very advanced form of early-stage bladder cancer (non-muscle-invasive) that cannot be fully removed by standard surgery. Treatment decisions will be guided by a urine-based DNA test (liquid biopsy) that tracks tumor activity. The goal is to see if immunotherapy can control the cancer and avoid the need to remove the bladder. **You may be eligible if...** - You are 18 years or older - You have confirmed very-high-risk non-muscle-invasive bladder cancer - Your cancer cannot be fully removed by standard surgery - You are not eligible for or have declined bladder removal surgery - You are in reasonably good health (ECOG 0–2) - You are able to provide urine samples during treatment and follow-up **You may NOT be eligible if...** - Your cancer has grown into the bladder muscle or spread to other parts of the body - You have had prior immunotherapy for bladder cancer - You have an active autoimmune disease requiring immune-suppressing treatment - You are pregnant or breastfeeding - You have an uncontrolled active infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSystemic 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.