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

NCT07475403 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-03-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Tianjin Medical University Second Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2028-04-01
Completion
2029-04-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07475403 on ClinicalTrials.gov