Bladder (Urothelial, Transitional Cell) CancerPhase 2NCT07625527
Is Prolonged Systemic Immunotherapy Necessary After Achieving Tumor-free Status in Patients With Extensive Transurethrally Unresectable Very-high-risk NMIBC?
A Phase 2 study testing Active Surveillance and PD-1/PD-L1 Inhibitor-Based Systemic Immunotherapy in people with Bladder (Urothelial, Transitional Cell) Cancer and Non Muscle Invasive Bladder Cancer, run by Tianjin Medical University Second Hospital at 4 sites in China.
Trial summary
Patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC) may achieve a tumor-free status after systemic immunotherapy-based bladder-sparing treatment combined with transurethral resection of bladder tumor (TURBT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer, Non Muscle Invasive Bladder Cancer
- What is being tested?
- Active Surveillance and PD-1/PD-L1 Inhibitor-Based Systemic Immunotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesChina
- Study dates
- 30 May 2026to 30 May 2032
- 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
- Has histologically confirmed very-high-risk non-muscle-invasive urothelial carcinoma of the bladder.
- Has transurethrally unresectable bladder tumor, defined as visually incomplete TURBT and/or extensive high-volume disease considered unsuitable for complete and oncologically adequate transurethral resection.
- Has undergone cystoscopy and TURBT evaluation before study enrollment.
- Has received systemic PD-1/PD-L1 inhibitor-based bladder-sparing therapy before randomization.
- Has achieved tumor-free status before randomization, defined as:
- No visible bladder tumor on cystoscopy;
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- Negative bladder biopsy and/or TURBT pathology;
- Negative urine cytology;
- Negative urinary tumor DNA (utDNA);
- No radiographic evidence of progression or metastasis.
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Has adequate organ function.
- Has provided written informed consent.
- Cohort A Only
- Achieved tumor-free status at the initial response evaluation after induction systemic therapy.
- Maintained tumor-free status after additional systemic therapy before randomization.
- Cohort B Only
- Did not achieve tumor-free status at the initial response evaluation because of residual non-muscle-invasive disease.
- Subsequently underwent complete TURBT/resection of residual disease followed by additional systemic therapy.
- Achieved tumor-free status at the second response evaluation before randomization.
Who cannot join
- Has muscle-invasive bladder cancer (≥T2), locally advanced unresectable disease, nodal disease, or distant metastasis.
- Has concurrent upper tract urothelial carcinoma.
- Has persistent visible tumor, positive bladder pathology, positive urine cytology, or positive utDNA before randomization.
- Has received prior systemic immunotherapy for metastatic urothelial carcinoma.
- Has active autoimmune disease requiring systemic treatment.
- Is receiving systemic immunosuppressive therapy.
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- Has uncontrolled infection requiring systemic therapy.
- Has another active malignancy requiring systemic treatment.
- Has known active hepatitis B, hepatitis C, human immunodeficiency virus infection, or active tuberculosis.
- Has pregnancy or breastfeeding.
- Has any medical or psychiatric condition that, in the investigator's judgment, would interfere with study participation or interpretation of results.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yunkai Qie, MD contact
China4 sites, 4 recruiting
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, 300000
Hailong Hu, +8619801518556, huhailong@tmu.edu.cn
- Recruiting
General Hospital of Tianjin Medical University
Tianjin
Liang Wang, +8615620530409, wjlmnwk@163.com
- Recruiting
Tianjin Hospital
Tianjin
Guangbin Zhu, +8613903124399, zgb2016@163.com
- Recruiting
Xingtai People's Hospital
Xingtai
Junli Wei, +8617299180245, wjluro@163.com
About this study
Official title: Randomized Trial of Active Surveillance Versus Continued Systemic Immunotherapy After Achieving Tumor-Free Status in Extensive Transurethrally Unresectable Very-High-Risk NMIBC
Patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC) may achieve a tumor-free status after systemic immunotherapy-based bladder-sparing treatment combined with transurethral resection of bladder tumor (TURBT). However, the optimal duration of systemic immunotherapy after achieving a tumor-free status remains uncertain. Prolonged treatment may increase toxicity, treatment burden, and cost, while some patients may maintain durable disease control without continued therapy.
This randomized study aims to evaluate whether active surveillance after achieving tumor-free status is a feasible alternative to continued systemic immunotherapy in patients with extensive transurethrally unresectable very-high-risk NMIBC.
Read more
Patients will initially receive systemic immunotherapy-based treatment followed by disease evaluation using cystoscopy with biopsy and/or TURBT, urine cytology, urinary tumor DNA (utDNA), and imaging assessments. Patients who achieve tumor-free status after treatment and complete resection of visible disease will be randomized to either active surveillance or continued systemic immunotherapy.
The study will evaluate recurrence outcomes, bladder preservation, progression, safety, and patient management strategies following achievement of tumor-free status. The trial also aims to explore the role of urinary tumor DNA in identifying patients who may safely undergo treatment de-escalation and active surveillance.
- Being tested
- Active Surveillance, PD-1/PD-L1 Inhibitor-Based Systemic Immunotherapy
- Keywords
- Non-muscle-invasive bladder cancer (NMIBC), Liquid biopsy, Immunotherapy
- Medical subject headings
- 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 SurveillanceBehavioural
Patients undergo protocol-defined surveillance after achieving tumor-free status, including cystoscopy, biopsy as clinically indicated, urine cytology, urinary tumor DNA testing, and imaging assessments, without continued systemic PD-1/PD-L1 inhibitor therapy unless disease recurrence or progression occurs.
PD-1/PD-L1 Inhibitor-Based Systemic ImmunotherapyDrug
Patients continue protocol-defined systemic PD-1/PD-L1 inhibitor therapy after achieving tumor-free status for up to approximately 1 year, with ongoing surveillance including cystoscopy, urine cytology, urinary tumor DNA testing, and imaging assessments.
| Study group | Role | What they receive |
|---|---|---|
| Arm A-1 (Cohort A Active Surveillance) | Experimental | Patients in Cohort A who achieve early tumor-free status after initial systemic immunotherapy-based treatment will undergo active surveillance with protocol-defined cystoscopy, urine cytology, urinary tumor DNA testing, biopsy as clinically indicated, and imaging assessments. Receives: Behavioral: Active Surveillance |
| Arm A-2 (Cohort A Continued Systemic Immunotherapy) | Active comparator | Patients in Cohort A who achieve early tumor-free status after initial systemic immunotherapy-based treatment will continue systemic immunotherapy for a protocol-defined duration with ongoing disease surveillance. Receives: Drug: PD-1/PD-L1 Inhibitor-Based Systemic Immunotherapy |
| Arm B-1 (Cohort B Active Surveillance) | Experimental | Patients in Cohort B who do not achieve tumor-free status at initial evaluation but subsequently achieve tumor-free status after complete TURBT/resection and additional systemic immunotherapy will undergo active surveillance with protocol-defined surveillance assessments. Receives: Behavioral: Active Surveillance |
| Arm B-2 (Cohort B Continued Systemic Immunotherapy) | Active comparator | Patients in Cohort B who subsequently achieve tumor-free status after complete TURBT/resection and additional systemic immunotherapy will continue systemic immunotherapy for a protocol-defined duration with ongoing disease surveillance. Receives: Drug: PD-1/PD-L1 Inhibitor-Based Systemic Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder-intact event-free survival (BI-EFS)
Time from randomization to the first occurrence of high-risk NMIBC recurrence, progression to muscle-invasive bladder cancer, distant metastasis, radical cystectomy, or death from any cause.
Measured: Up to 2 years from randomization
Secondary outcomes (5)
Recurrence-free survival (RFS)
Time from randomization to the first documented recurrence of bladder cancer or death from any cause.
Measured: Up to 2 years from randomization
Progression-free survival (PFS)
Time from randomization to progression to muscle-invasive, locally advanced, or metastatic bladder cancer, or death from any cause.
Measured: Up to 2 years from randomization
Radical cystectomy-free survival (RCFS)
Time from randomization to radical cystectomy or death from any cause.
Measured: Up to 2 years from randomization
Overall survival (OS)
Time from randomization to death from any cause.
Measured: Up to 2 years from randomization
Incidence of treatment-related adverse events
Proportion of patients experiencing treatment-related adverse events, graded according to CTCAE.
Measured: Up to 2 years from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start30 May 2026
- Primary completion30 Mar 2029 (estimated)
- Study completion30 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder (Urothelial, Transitional Cell) 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer will initially receive systemic PD-1/PD-L1 immunotherapy-based bladder-sparing treatment followed by disease evaluation. Patients achieving tumor-free status after treatment, TURBT, and/or complete resection of visible disease will be randomized in parallel to active surveillance or continued systemic immunotherapy. Randomization will occur within two predefined cohorts based on response status at initial disease evaluation.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hailong Hu, MD, Principal investigator, Department of Urology, The Second Hospital of Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625527
- Sponsor's protocol ID
- Truce-LB03
- Status last verified
- Oct 2026
- First submitted
- 21 May 2026
- Last updated
- 15 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Active Surveillance Versus Continued Systemic Immunotherapy After Achieving Tumor-Free Status in Extensive Transurethrally Unresectable Very-High-Risk NMIBC
- ClinicalTrials.gov ID
- NCT07625527
- Acronym / sponsor ID
- Truce-LB03
- Keywords
- Non-muscle-invasive bladder cancer (NMIBC), Liquid biopsy, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 May 2032 (estimated)
- First posted
- 4 Jun 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.
Patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC) may achieve a tumor-free status after systemic immunotherapy-based bladder-sparing treatment combined with transurethral resection of bladder tumor (TURBT). However, the optimal duration of systemic immunotherapy after achieving a tumor-free status remains uncertain. Prolonged treatment may increase toxicity, treatment burden, and cost, while some patients may maintain durable disease control without continued therapy.
This randomized study aims to evaluate whether active surveillance after achieving tumor-free status is a feasible alternative to continued systemic immunotherapy in patients with extensive transurethrally unresectable very-high-risk NMIBC.
Patients will initially receive systemic immunotherapy-based treatment followed by disease evaluation using cystoscopy with biopsy and/or TURBT, urine cytology, urinary tumor DNA (utDNA), and imaging assessments. Patients who achieve tumor-free status after treatment and complete resection of visible disease will be randomized to either active surveillance or continued systemic immunotherapy.
The study will evaluate recurrence outcomes, bladder preservation, progression, safety, and patient management strategies following achievement of tumor-free status. The trial also aims to explore the role of urinary tumor DNA in identifying patients who may safely undergo treatment de-escalation and active surveillance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer will initially receive systemic PD-1/PD-L1 immunotherapy-based bladder-sparing treatment followed by disease evaluation. Patients achieving tumor-free status after treatment, TURBT, and/or complete resection of visible disease will be randomized in parallel to active surveillance or continued systemic immunotherapy. Randomization will occur within two predefined cohorts based on response status at initial disease evaluation.
| Arm | Type | Receives |
|---|---|---|
| Arm A-1 (Cohort A Active Surveillance) | Experimental | Behavioral: Active SurveillancePatients in Cohort A who achieve early tumor-free status after initial systemic immunotherapy-based treatment will undergo active surveillance with protocol-defined cystoscopy, urine cytology, urinary tumor DNA testing, biopsy as clinically indicated, and imaging assessments. |
| Arm A-2 (Cohort A Continued Systemic Immunotherapy) | Active comparator | Drug: PD-1/PD-L1 Inhibitor-Based Systemic ImmunotherapyPatients in Cohort A who achieve early tumor-free status after initial systemic immunotherapy-based treatment will continue systemic immunotherapy for a protocol-defined duration with ongoing disease surveillance. |
| Arm B-1 (Cohort B Active Surveillance) | Experimental | Behavioral: Active SurveillancePatients in Cohort B who do not achieve tumor-free status at initial evaluation but subsequently achieve tumor-free status after complete TURBT/resection and additional systemic immunotherapy will undergo active surveillance with protocol-defined surveillance assessments. |
| Arm B-2 (Cohort B Continued Systemic Immunotherapy) | Active comparator | Drug: PD-1/PD-L1 Inhibitor-Based Systemic ImmunotherapyPatients in Cohort B who subsequently achieve tumor-free status after complete TURBT/resection and additional systemic immunotherapy will continue systemic immunotherapy for a protocol-defined duration with ongoing disease surveillance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Has histologically confirmed very-high-risk non-muscle-invasive urothelial carcinoma of the bladder.
- Has transurethrally unresectable bladder tumor, defined as visually incomplete TURBT and/or extensive high-volume disease considered unsuitable for complete and oncologically adequate transurethral resection.
- Has undergone cystoscopy and TURBT evaluation before study enrollment.
- Has received systemic PD-1/PD-L1 inhibitor-based bladder-sparing therapy before randomization.
- Has achieved tumor-free status before randomization, defined as:
Key exclusion criteria (11 listed)
- Has muscle-invasive bladder cancer (≥T2), locally advanced unresectable disease, nodal disease, or distant metastasis.
- Has concurrent upper tract urothelial carcinoma.
- Has persistent visible tumor, positive bladder pathology, positive urine cytology, or positive utDNA before randomization.
- Has received prior systemic immunotherapy for metastatic urothelial carcinoma.
- Has active autoimmune disease requiring systemic treatment.
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 SurveillancePatients undergo protocol-defined surveillance after achieving tumor-free status, including cystoscopy, biopsy as clinically indicated, urine cytology, urinary tumor DNA testing, and imaging assessments, without continued systemic PD-1/PD-L1 inhibitor therapy unless disease recurrence or progression occurs. | Behavioural | Arm A-1 (Cohort A Active Surveillance), Arm B-1 (Cohort B Active Surveillance) |
| PD-1/PD-L1 Inhibitor-Based Systemic ImmunotherapyPatients continue protocol-defined systemic PD-1/PD-L1 inhibitor therapy after achieving tumor-free status for up to approximately 1 year, with ongoing surveillance including cystoscopy, urine cytology, urinary tumor DNA testing, and imaging assessments. | Drug | Arm A-2 (Cohort A Continued Systemic Immunotherapy), Arm B-2 (Cohort B Continued Systemic Immunotherapy) |
Primary outcome
Bladder-intact event-free survival (BI-EFS)
Time frame: Up to 2 years from randomization
Time from randomization to the first occurrence of high-risk NMIBC recurrence, progression to muscle-invasive bladder cancer, distant metastasis, radical cystectomy, or death from any cause.
5 secondary outcomes
Recurrence-free survival (RFS)
Time frame: Up to 2 years from randomization
Progression-free survival (PFS)
Time frame: Up to 2 years from randomization
Radical cystectomy-free survival (RCFS)
Time frame: Up to 2 years from randomization
Overall survival (OS)
Time frame: Up to 2 years from randomization
Incidence of treatment-related adverse events
Time frame: Up to 2 years from randomization
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 15 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.
Yunkai Qie, MD contact
Hailong Hu, MD principal investigator
Department of Urology, The Second Hospital of Tianjin Medical University
4 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 Active Surveillance and PD-1/PD-L1 Inhibitor-Based Systemic Immunotherapy in people with Bladder (Urothelial, Transitional Cell) Cancer and Non Muscle Invasive Bladder Cancer, run by Tianjin Medical University Second Hospital at 4 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 20 inclusion and 11 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 15 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 4 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, 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?
Bladder-intact event-free survival (BI-EFS) (time frame: Up to 2 years from 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 15 Oct 2026.