Bladder CancerNCT07749924
Active Surveillance Versus Adjuvant Intravesical Chemotherapy in Liquid Biopsy-Defined Low-Shedding Intermediate-Risk NMIBC
A study testing Active Surveillance and Adjuvant Intravesical Chemotherapy in people with Bladder Cancer and Non-Muscle-Invasive Bladder Cancer (NMIBC), run by Tianjin Medical University Second Hospital at 5 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Non-Muscle-Invasive Bladder Cancer (NMIBC)
- What is being tested?
- Active Surveillance and Adjuvant Intravesical Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 670 participants
- Where
- 5 sitesChina
- Study dates
- 10 Aug 2026to 1 Mar 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Daqing Oil General Hopital
Daqing
Liliang Li, MD, +8617190928809, lililiangmed@gmail.com
- Recruiting
Nanchang Second People's Hospital
Nanchang
Tao Zeng, MD, +8617142891923, zturology@163.com
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, 300000
Hailong Hu, MD, +8619801518556, huhailong@tmu.edu.cn
- Recruiting
General Hospital of Tianjin Medical University
Tianjin
Liang Wang, +8613733356171, wjlmnwk@163.com
- Recruiting
Tianjin Hospital
Tianjin
Guangbin Zhu, MD, +8615141328897, zturology@163.com
About this study
Official 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
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.
Read more
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.
- Being tested
- Active Surveillance, Adjuvant Intravesical Chemotherapy
- Keywords
- Non-muscle-invasive bladder cancer (NMIBC), Active surveillance, Liquid biopsy
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active SurveillanceOther
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 ChemotherapyDrug
Also called Gemcitabine, Mitomycin C, Epirubicin
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 group | Role | What they receive |
|---|---|---|
| Active Surveillance | Experimental | 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. Receives: Other: Active Surveillance |
| Adjuvant Intravesical Chemotherapy | Active comparator | 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. Receives: Drug: Adjuvant Intravesical Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
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.
Measured: Up to 24 months after randomization
Secondary outcomes (6)
High-grade recurrence-free survival
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.
Measured: Frame: Up to 24 months after randomization
Progression-free survival
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.
Measured: Up to 24 months after randomization
Overall Survival
Defined as the time from randomization to the date of death from any cause
Measured: Up to 24 months after randomization
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores
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.
Measured: Baseline, Weeks 6, 12, 24, 36, and 48
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores
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.
Measured: Baseline, Weeks 6, 12, 24, 36, and 48
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores
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.
Measured: Baseline, Weeks 6, 12, 24, 36, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start10 Aug 2026
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749924
- Sponsor's protocol ID
- Truce-LB04
- Status last verified
- Oct 2026
- First submitted
- 2 Aug 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07749924
- Acronym / sponsor ID
- Truce-LB04
- Keywords
- Non-muscle-invasive bladder cancer (NMIBC), Active surveillance, Liquid biopsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2032 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Surveillance | Experimental | Other: Active SurveillanceParticipants 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. |
| Adjuvant Intravesical Chemotherapy | Active comparator | Drug: Adjuvant Intravesical ChemotherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active SurveillanceParticipants 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. | Other | Active Surveillance |
| Adjuvant Intravesical ChemotherapyAlso: Gemcitabine, Mitomycin C, EpirubicinParticipants 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. | Drug | Adjuvant Intravesical Chemotherapy |
Primary outcome
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.
6 secondary outcomes
High-grade recurrence-free survival
Time frame: Frame: Up to 24 months after randomization
Progression-free survival
Time frame: Up to 24 months after randomization
Overall Survival
Time frame: Up to 24 months after randomization
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
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
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores
Time frame: Baseline, Weeks 6, 12, 24, 36, and 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Surveillance and Adjuvant Intravesical Chemotherapy in people with Bladder Cancer and Non-Muscle-Invasive Bladder Cancer (NMIBC), run by Tianjin Medical University Second Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hailong Hu, MD (+8619801518556, huhailong@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: Up to 24 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.