Active Surveillance Versus Adjuvant Intravesical Chemotherapy in Liquid Biopsy-Defined Low-Shedding Intermediate-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
This study will evaluate whether adjuvant intravesical chemotherapy can be safely omitted under active surveillance after complete transurethral resection in selected patients with EAU intermediate-risk non-muscle-invasive bladder cancer. Patients with intermediate-risk non-muscle-invasive bladder cancer are commonly treated with transurethral resection followed by adjuvant intravesical chemotherapy to reduce the risk of recurrence. However, not all patients may derive the same benefit from additional intravesical treatment. Some tumors may have a low-shedding phenotype, meaning that they show no detectable tumor-associated signals in urine despite the presence of visible bladder tumors. In this study, preoperative urine-based liquid biopsy will be used to identify patients with a low-shedding profile. This profile is defined by negative results across urine cytology, NMP22, urinary DNA methylation, and urinary tumor DNA testing before transurethral resection. Eligible patients with EAU intermediate-risk non-muscle-invasive bladder cancer, a negative preoperative urine-based liquid biopsy profile, and complete tumor resection will be randomly assigned to active surveillance or standard adjuvant intravesical chemotherapy. The study will compare recurrence-free survival between the two groups and assess whether active surveillance can avoid immediate intravesical chemotherapy without compromising oncologic safety. Secondary outcomes will include high-grade recurrence, disease progression, need for subsequent bladder cancer treatment, safety, patient-reported outcomes.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony histologicznie rak urotelu pęcherza moczowego
- •Rak pęcherza sklasyfikowany jako pośredniego ryzyka wg europejskich wytycznych
- •Całkowite usunięcie widocznego guza w ciągu 6 tygodni przed włączeniem do badania
- •Negatywne wyniki testów biomarkerów w moczu po operacji
- •Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu
- •Zdolność do zrozumienia wymagań badania i podpisania zgody
✗ Disqualifies
- •Rak pęcherza klasyfikowany jako niskiego lub wysokiego ryzyka
- •Obecność nowotworu in situ w pęcherzu
- •Rak naciekający mięsień pęcherza lub przerzuty
- •Niekompletne usunięcie guza lub reszty widocznego nowotworu
- •Rak obejmujący prostatę
- •Poważne dysfunkcje dolnych dróg moczowych uniemożliwiające leczenie
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 9, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (5)
Daqing Oil General Hopital
Daqing, China
Nanchang Second People's Hospital
Nanchang, China
The Second Hospital of Tianjin Medical University
Tianjin, China
General Hospital of Tianjin Medical University
Tianjin, China
Tianjin Hospital
Tianjin, China
Trial contact
Hailong Hu, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/10/2026.
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