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NCT Number: NCT07749924

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

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.

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Key information

Conditions

Bladder Cancer Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Non-Muscle-Invasive Bladder Cancer (NMIBC) Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daqing Oil General Hopital, Daqing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years.
  • Histologically confirmed urothelial carcinoma of the urinary bladder, including tumors with divergent differentiation, provided that the urothelial carcinoma component accounts for >50% of the tumor
  • Non-muscle-invasive bladder cancer classified as intermediate-risk according to the 2021 European Association of Urology (EAU) NMIBC prognostic risk-group definition. Intermediate-risk disease is defined as NMIBC without concomitant carcinoma in situ that does not meet the criteria for the EAU low-, high-, or very-high-risk groups.
  • Complete transurethral resection of all visible bladder tumors performed within 6 weeks before randomization, with no macroscopically visible residual disease.
  • Negative multi-urinary liquid biopsy results after complete TURBT and before randomization.
  • Eastern Cooperative Oncology Group performance status of 0-2.
  • Adequate clinical condition to undergo protocol-specified intravesical therapy, cystoscopic surveillance, and study-related procedures.
  • Ability to understand the study requirements and provide written informed consent.

Exclusion criteria

  • EAU low-risk, high-risk, or very-high-risk NMIBC.
  • Any current or previous concomitant carcinoma in situ associated with the qualifying tumor episode.
  • Muscle-invasive bladder cancer, locally advanced urothelial carcinoma, lymph-node involvement, or metastatic urothelial carcinoma.

Incomplete TURBT, macroscopically visible residual tumor, or inability to achieve complete endoscopic resection before randomization.

  • Urothelial carcinoma involving the prostatic stroma or prostatic ducts, or carcinoma in situ of the prostatic urethra.
  • Severe lower urinary tract dysfunction, bladder capacity considered insufficient for intravesical treatment, or another clinically significant urological condition that may interfere with treatment or outcome assessment.
  • Another active malignancy requiring systemic treatment or likely to interfere with the assessment of study endpoints, except adequately treated non-melanoma skin cancer, localized prostate cancer under surveillance, or another malignancy with a negligible risk of recurrence, as determined by the investigator.
  • Pregnant or breastfeeding women.
  • Any serious uncontrolled medical, psychiatric, or social condition that, in the investigator's judgment, would compromise participant safety, protocol adherence, or interpretation of study results.

Treatment and study plan

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.

Other names: Gemcitabine, Mitomycin C, Epirubicin

Primary outcomes

  1. Recurrence-free survival

    Time frame: Up to 24 months after randomization

    Recurrence-free survival is defined as the time from randomization to the first histologically confirmed intravesical recurrence or death from any cause, whichever occurs first.

Secondary outcomes

  1. High-grade recurrence-free survival

    Time frame: Frame: Up to 24 months after randomization

    High-grade recurrence-free survival is defined as the time from randomization to the first histologically confirmed high-grade intravesical recurrence or death from any cause, whichever occurs first.

  2. Progression-free survival

    Time frame: Up to 24 months after randomization

    Progression-free survival is defined as the time from randomization to the first occurrence of T1 high-grade disease, carcinoma in situ, muscle-invasive bladder cancer, upper tract urothelial carcinoma, nodal or distant metastasis, radical cystectomy, or death from any cause.

  3. Overall Survival

    Time frame: Up to 24 months after randomization

    Defined as the time from randomization to the date of death from any cause

  4. European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores

    Time frame: Baseline, Weeks 6, 12, 24, 36, and 48

    EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.

  5. European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores

    Time frame: Baseline, Weeks 6, 12, 24, 36, and 48

    EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.

  6. EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores

    Time frame: Baseline, Weeks 6, 12, 24, 36, and 48

    The EQ-5D-5L is a standardized questionnaire used to assess participants' general health status and health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, ranging from 1 (no problems) to 5 (extreme problems or unable to perform). Responses can be converted into a health utility index score using an appropriate value set, with higher index scores indicating better health status. The EQ-5D-5L also includes a visual analogue scale (EQ VAS), ranging from 0 to 100, where higher scores indicate better self-rated health.

Study contacts

Contact information is provided by the study sponsor or research team.

Hailong Hu, MD

CONTACT

[email protected]

+8619801518556

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Second Hospital

Other

Registry information

Official study title

A Prospective, Multicenter, Randomized, Open-Label, Non-Inferiority Trial of Active Surveillance Versus Adjuvant Intravesical Chemotherapy After Complete Transurethral Resection in Patients With Preoperative Liquid Biopsy-Negative, Intermediate-Risk Non-Muscle-Invasive Bladder Cancer

Important dates

Study start
2026
Primary completion
2029
Study completion
2032
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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