Active Surveillance Versus Adjuvant Intravesical Chemotherapy in Liquid Biopsy-Defined Low-Shedding Intermediate-Risk NMIBC

Sponsor
Tianjin Medical University Second Hospital
Study ID
NCT07749924
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active Surveillance — OTHER
    Participants assigned to active surveillance will not receive adjuvant intravesical chemotherapy after complete transurethral resection of bladder tumor. They will undergo scheduled follow-up assessments, including cystoscopy, urine cytology, urine-based liquid biopsy testing, imaging when clinically indicated, and other evaluations according to the study protocol. Further diagnostic evaluation or treatment will be initiated if recurrence or progression is suspected or confirmed.
  • Adjuvant Intravesical Chemotherapy — DRUG
    Participants assigned to this intervention will receive one year of adjuvant intravesical chemotherapy after complete transurethral resection of bladder tumor. Gemcitabine is the preferred protocol-specified agent. Mitomycin C or epirubicin may be used as protocol-allowed alternatives when gemcitabine is unavailable, contraindicated, or not routinely used at the participating center. Treatment will include an induction course followed by maintenance intravesical instillations for up to 12 months.

Study Details

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.

Key Dates

First listed
Aug 6, 2026
Start date
Aug 10, 2026
Status verified
Aug 2026
Primary completion
Mar 1, 2029
Completion
Mar 1, 2032

Study Design

Enrollment
670 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Surveillance
    Participants assigned to this arm will undergo active surveillance after complete transurethral resection of bladder tumor. No adjuvant intravesical chemotherapy will be given. Surveillance will include scheduled cystoscopy, urine cytology, urine-based liquid biopsy testing, and other assessments according to the study protocol. Further diagnostic evaluation or treatment will be performed if recurrence or progression is suspected or confirmed.
  • Active Comparator: Adjuvant Intravesical Chemotherapy
    Participants assigned to this arm will receive one year of adjuvant intravesical chemotherapy after complete transurethral resection of bladder tumor. The preferred agent is gemcitabine; mitomycin C or epirubicin may be used as protocol-allowed alternatives when gemcitabine is unavailable, contraindicated, or not routinely used at the participating center. The planned agent will be specified before randomization. Treatment will consist of an induction course of weekly intravesical instillations followed by maintenance instillations for up to 12 months, according to the study protocol.

Primary Outcome Measure

Recurrence-free survival [ Time Frame: Up to 24 months after randomization ]

Central Contacts

Find similar trials

Nationwide
Bladder cancer trialsOncology trialsUrology trials

Related Studies