Bladder CancerPhase 2NCT07475403
Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer
A Phase 2 study testing Systemic immunotherapy in people with Bladder Cancer and Liquid Biopsy, run by Tianjin Medical University Second Hospital at 3 sites in China.
Trial summary
This study evaluates whether urinary tumor DNA (utDNA) testing, together with clinical, pathologic, and radiographic assessment, can help guide treatment discontinuation and active surveillance in patients with unresectable very-high-risk non-muscle-invasive bladder cancer (VHR NMIBC) treated with bladder-sparing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Liquid Biopsy, Immunotherapy
- What is being tested?
- Systemic immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesChina
- Study dates
- 16 Mar 2026to 1 Apr 2029
- Phase
- Phase 2
- 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 non-muscle-invasive urothelial carcinoma of the bladder classified as very-high-risk (VHR) according to EAU 2025 guideline criteria.
- Disease considered unresectable by the investigator and multidisciplinary team, defined as complete tumor eradication by standard transurethral resection of bladder tumor (TURBT) being not feasible or unlikely to achieve adequate local control.
- Patients who are ineligible or refuse for radical cystectomy, after discussion with the treating team.
- At least one measurable or evaluable bladder lesion/documented residual disease suitable for response assessment by cystoscopy, TURBT/biopsy, pathology, urine cytology, and urinary tumor DNA (utDNA) testing.
- ECOG performance status 0-2.
Show all 9Show fewer
- Adequate organ function, including:
- Hematologic function: Absolute neutrophil count ≥1.5 × 10⁹/L, Platelet count ≥100 × 10⁹/L, Hemoglobin ≥9 g/dL Hepatic function: Total bilirubin ≤1.5 × ULN, AST ≤2.5 × ULN, ALT ≤2.5 × ULN Renal function: Serum creatinine ≤1.5 × ULN or Creatinine clearance ≥60 mL/min.
- Ability to provide urine samples for utDNA testing and urine cytology during treatment and follow-up.
Who cannot join
- Muscle-invasive bladder cancer (≥T2), locally advanced unresectable invasive disease beyond NMIBC, or metastatic urothelial carcinoma at baseline.
- Histology showing predominant or pure non-urothelial carcinoma of the bladder that, in the investigator's judgment, would make the patient unsuitable for this protocol.
- Prior treatment with immune.
- Active autoimmune disease or history of autoimmune disease requiring systemic immunosuppressive treatment and considered incompatible with immune checkpoint inhibitor therapy.
- Ongoing systemic immunosuppressive therapy exceeding protocol-allowed doses.
- 7. Active uncontrolled infection, including uncontrolled urinary tract infection, that would interfere with study treatment or response assessment.
- 8. Any medical condition that would preclude safe administration of systemic immunotherapy or protocol-required cystoscopy/TURBT/biopsy, in the investigator's judgment.
- 9. Concurrent other malignancy. 10. Pregnant or breastfeeding women. 11. Inability to comply with protocol procedures or follow-up.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, 300000
Hailong Hu, +8615620530409, xzh200049@163.com
- Recruiting
Tianjin Hospital
Tianjin
Guangbin Zhu, +8613662096232, zgb111@163.com
- Recruiting
Xingtai People's Hospital
Xingtai
Junli Wei, +8615620530409, wjlmnwk@163.com
About this study
Official title: A Prospective Study of Urinary Tumor DNA-Guided Systemic Immunotherapy in Patients With Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer
This study evaluates whether urinary tumor DNA (utDNA) testing, together with clinical, pathologic, and radiographic assessment, can help guide treatment discontinuation and active surveillance in patients with unresectable very-high-risk non-muscle-invasive bladder cancer (VHR NMIBC) treated with bladder-sparing systemic immunotherapy.
Participants receive systemic immune checkpoint inhibitor-based therapy every 3 weeks for an initial 3 cycles. Initial response assessment is performed using transurethral resection of bladder tumor (TURBT) and chest and abdominopelvic computed tomography (CT). Participants without progression to muscle-invasive, regional nodal, or distant metastatic disease then undergo post-TURBT urine cytology and urinary tumor DNA (utDNA) testing. Participants with both negative urine cytology and negative utDNA results receive an additional 3 cycles of systemic immunotherapy.
Read more
After the additional treatment, participants undergo repeat evaluation using cystoscopy with biopsy, urine cytology, utDNA testing, and chest and abdominopelvic CT. Participants with negative findings on cystoscopic biopsy, urine cytology, and utDNA testing, and without radiographic evidence of nodal or distant metastatic disease, discontinue systemic immunotherapy and enter an active surveillance phase with regular follow-up monitoring. Participants who do not meet these criteria continue further clinical management and follow-up according to institutional practice.
The study aims to determine whether a shortened duration of systemic immunotherapy guided by integrated molecular, clinical, pathologic, and radiographic response assessment can maintain favorable oncologic outcomes while reducing unnecessary treatment exposure in this high-risk population.
- Conditions
- Bladder Cancer, Liquid Biopsy, Immunotherapy
- Being tested
- Systemic immunotherapy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic immunotherapyDrug
Participants receive systemic immune checkpoint inhibitor-based therapy administered intravenously every 3 weeks for an initial 3 cycles. Treatment response is initially assessed using transurethral resection of bladder tumor (TURBT) to evaluate pathologic stage. Participants without progression to muscle-invasive or metastatic disease subsequently undergo post-TURBT urine cytology and urinary tumor DNA (utDNA) testing. Participants with both negative urine cytology and negative utDNA results receive an additional 3 cycles of systemic immunotherapy.
Following the additional treatment, participants undergo repeat evaluation using cystoscopy with biopsy, urine cytology, and utDNA testing. Participants with negative findings on cystoscopic biopsy, urine cytology, and utDNA testing discontinue systemic immunotherapy and enter an active surveillance phase with regular follow-up monitoring. Participants who do not meet these criteria continue further clinical management and follow-up accord
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Drug: Systemic immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival
Event-free survival is defined as the time from initiation of systemic immunotherapy to the first occurrence of any of the following events after entry into the active surveillance phase: histologically confirmed intravesical recurrence of urothelial carcinoma, progression to muscle-invasive bladder cancer (≥T2 disease), regional lymph node or distant metastasis identified on chest or abdominopelvic computed tomography (CT), radical cystectomy, or death from any cause..
Residual non-muscle-invasive bladder cancer identified during the initial TURBT-based response assessment is not considered an event. Isolated urinary tumor DNA (utDNA) positivity without pathologically confirmed disease recurrence or progression is not considered an event.
Measured: Up to 2 years first administration of systemic immunotherapy
Secondary outcomes (4)
Duration of Complete Response
Duration of complete response is defined, among participants who achieve confirmed complete clinical response (cCR) at repeat evaluation after additional systemic immunotherapy, as the time from the first documentation of confirmed cCR to the first occurrence of any of the following events: histologically confirmed intravesical recurrence of urothelial carcinoma, progression to muscle-invasive bladder cancer (≥T2 disease), regional lymph node or distant metastasis identified on imaging evaluation, radical cystectomy, or death from any cause.
Confirmed complete clinical response is defined as negative findings on cystoscopy with biopsy, negative urine cytology, negative urinary tumor DNA (utDNA), and absence of muscle-invasive, nodal, or metastatic disease on chest and abdominopelvic computed tomography (CT).
Isolated urinary tumor DNA (utDNA) positivity without pathologically confirmed disease recurrence or radiographically confirmed progression is not considered an event.
Measured: Up to 2 years from first documented complete clinical response
Radical Cystectomy-Free Survival
Radical cystectomy-free survival is defined as the time from the first administration of systemic immunotherapy to the first occurrence of either radical cystectomy or death from any cause.
Measured: Up to 2 years from first administration of systemic immunotherapy
Overall Survival
Overall survival is defined as the time from the first administration of systemic immunotherapy to death from any cause.
Measured: Up to 2 years from first administration of systemic immunotherapy
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as the time from the first dose of study treatment up to 30 days after last dose of study treatment or 1 day before start day of new anti-cancer therapy.
Measured: From first administration of systemic immunotherapy up to 30 days after last administration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start16 Mar 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2029 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 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
- NCT07475403
- Sponsor's protocol ID
- Truce-LB03B
- Status last verified
- May 2026
- First submitted
- 11 Mar 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, a decision regarding sharing individual participant data (IPD) has not been finalized. The study involves sensitive clinical and genomic information, including urinary tumor DNA (utDNA) data, and careful consideration is required to ensure protection of participant privacy and compliance with applicable ethical and regulatory requirements. Data sharing policies will be determined after study completion, taking into account institutional policies, participant consent, and data protection regulations. Requests for data may be considered on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Urinary Tumor DNA-Guided Systemic Immunotherapy in Patients With Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07475403
- Acronym / sponsor ID
- Truce-LB03B
- Conditions
- Bladder Cancer, Liquid Biopsy, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 16 Mar 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 evaluates whether urinary tumor DNA (utDNA) testing, together with clinical, pathologic, and radiographic assessment, can help guide treatment discontinuation and active surveillance in patients with unresectable very-high-risk non-muscle-invasive bladder cancer (VHR NMIBC) treated with bladder-sparing systemic immunotherapy.
Participants receive systemic immune checkpoint inhibitor-based therapy every 3 weeks for an initial 3 cycles. Initial response assessment is performed using transurethral resection of bladder tumor (TURBT) and chest and abdominopelvic computed tomography (CT). Participants without progression to muscle-invasive, regional nodal, or distant metastatic disease then undergo post-TURBT urine cytology and urinary tumor DNA (utDNA) testing. Participants with both negative urine cytology and negative utDNA results receive an additional 3 cycles of systemic immunotherapy.
After the additional treatment, participants undergo repeat evaluation using cystoscopy with biopsy, urine cytology, utDNA testing, and chest and abdominopelvic CT. Participants with negative findings on cystoscopic biopsy, urine cytology, and utDNA testing, and without radiographic evidence of nodal or distant metastatic disease, discontinue systemic immunotherapy and enter an active surveillance phase with regular follow-up monitoring. Participants who do not meet these criteria continue further clinical management and follow-up according to institutional practice.
The study aims to determine whether a shortened duration of systemic immunotherapy guided by integrated molecular, clinical, pathologic, and radiographic response assessment can maintain favorable oncologic outcomes while reducing unnecessary treatment exposure in this high-risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Systemic immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years.
- Histologically confirmed non-muscle-invasive urothelial carcinoma of the bladder classified as very-high-risk (VHR) according to EAU 2025 guideline criteria.
- Disease considered unresectable by the investigator and multidisciplinary team, defined as complete tumor eradication by standard transurethral resection of bladder tumor (TURBT) being not feasible or unlikely to achieve adequate local control.
- Patients who are ineligible or refuse for radical cystectomy, after discussion with the treating team.
- At least one measurable or evaluable bladder lesion/documented residual disease suitable for response assessment by cystoscopy, TURBT/biopsy, pathology, urine cytology, and urinary tumor DNA (utDNA) testing.
Key exclusion criteria (8 listed)
- Muscle-invasive bladder cancer (≥T2), locally advanced unresectable invasive disease beyond NMIBC, or metastatic urothelial carcinoma at baseline.
- Histology showing predominant or pure non-urothelial carcinoma of the bladder that, in the investigator's judgment, would make the patient unsuitable for this protocol.
- Prior treatment with immune.
- Active autoimmune disease or history of autoimmune disease requiring systemic immunosuppressive treatment and considered incompatible with immune checkpoint inhibitor therapy.
- Ongoing systemic immunosuppressive therapy exceeding protocol-allowed doses.
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 |
|---|---|---|
| Systemic immunotherapyParticipants receive systemic immune checkpoint inhibitor-based therapy administered intravenously every 3 weeks for an initial 3 cycles. Treatment response is initially assessed using transurethral resection of bladder tumor (TURBT) to evaluate pathologic stage. Participants without progression to muscle-invasive or metastatic disease subsequently undergo post-TURBT urine cytology and urinary tumor DNA (utDNA) testing. Participants with both negative urine cytology and negative utDNA results receive an additional 3 cycles of systemic immunotherapy. Following the additional treatment, participants undergo repeat evaluation using cystoscopy with biopsy, urine cytology, and utDNA testing. Participants with negative findings on cystoscopic biopsy, urine cytology, and utDNA testing discontinue systemic immunotherapy and enter an active surveillance phase with regular follow-up monitoring. Participants who do not meet these criteria continue further clinical management and follow-up accord | Drug | Study group |
Primary outcome
Event-Free Survival
Time frame: Up to 2 years first administration of systemic immunotherapy
Event-free survival is defined as the time from initiation of systemic immunotherapy to the first occurrence of any of the following events after entry into the active surveillance phase: histologically confirmed intravesical recurrence of urothelial carcinoma, progression to muscle-invasive bladder cancer (≥T2 disease), regional lymph node or distant metastasis identified on chest or abdominopelvic computed tomography (CT), radical cystectomy, or death from any cause.. Residual non-muscle-invasive bladder cancer identified during the initial TURBT-based response assessment is not considered an event. Isolated urinary tumor DNA (utDNA) positivity without pathologically confirmed disease recurrence or progression is not considered an event.
4 secondary outcomes
Duration of Complete Response
Time frame: Up to 2 years from first documented complete clinical response
Radical Cystectomy-Free Survival
Time frame: Up to 2 years from first administration of systemic immunotherapy
Overall Survival
Time frame: Up to 2 years from first administration of systemic immunotherapy
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From first administration of systemic immunotherapy up to 30 days after last administration of study
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 26 May 2026.
- Individual participant dataSharing planned: Undecided. At this stage, a decision regarding sharing individual participant data (IPD) has not been finalized. The study involves sensitive clinical and genomic information, including urinary tumor DNA (utDNA) data, and careful consideration is required to ensure protection of participant privacy and compliance with applicable ethical and regulatory requirements. Data sharing policies will be determined after study completion, taking into account institutional policies, participant consent, and data protection regulations. Requests for data may be considered on a case-by-case basis.
Related trials for Bladder Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 1
Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents
Bladder Cancer
RecruitingPhase 3
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Intermediate Risk Non-Muscle Invasive Bladder Cancer
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Systemic immunotherapy in people with Bladder Cancer and Liquid Biopsy, run by Tianjin Medical University Second Hospital at 3 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 9 inclusion and 8 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (+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?
Event-Free Survival (time frame: Up to 2 years first administration of systemic immunotherapy). 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 26 May 2026.