Is Prolonged Systemic Immunotherapy Necessary After Achieving Tumor-free Status in Patients With Extensive Transurethrally Unresectable Very-high-risk NMIBC?
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histologicznie bardzo wysoko-ryzykowny niemięśniowy rak pęcherza moczowego
- •Nowotwór nie dający się w pełni usunąć tradycyjnymi metodami chirurgicznymi
- •Wcześniejsze poddanie się leczeniu immunologicznym (inhibitory PD-1/PD-L1)
- •Całkowita remisja choroby - brak widocznego nowotworu, negatywne wyniki biopsji i badań moczu
- •Brak przerzutów potwierdzonych w badaniach obrazowych
- •Ogólny stan zdrowotna pozwalający na udział w badaniu
- •Pisemna zgoda na udział w badaniu
✗ Disqualifies
- •Rak pęcherza z naciekiem mięśnia (stadion zaawansowany)
- •Przerzuty do węzłów chłonnych lub narządów odległych
- •Aktywna choroba autoimmunologiczna wymagająca leczenia
- •Poprzednie leczenie immunologiczne za wcześniejsze zaawansowane stany choroby
- •Jednoczesny rak górnych dróg moczowych
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 15, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (4)
The Second Hospital of Tianjin Medical University
Tianjin, China
General Hospital of Tianjin Medical University
Tianjin, China
Tianjin Hospital
Tianjin, China
Xingtai People's Hospital
Xingtai, China
Trial contact
Hailong Hu, MD
Yunkai Qie, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/16/2026.
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