Could less be more? bladder cancer trial tests stopping immunotherapy after tumors vanish
NCT ID NCT07625527
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at people with a very high-risk type of bladder cancer that cannot be fully removed with standard surgery. After initial treatment with immunotherapy and surgery, some patients become tumor-free. The trial then randomly assigns them to either continue immunotherapy for up to a year or switch to active surveillance—regular checkups without further treatment unless the cancer returns. The goal is to see if active surveillance is a safe and effective option, potentially sparing patients from unnecessary side effects and costs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PD-1/PD-L1 inhibitor-based systemic immunotherapy
- What this could lead to
- If active surveillance works as well as continued therapy, patients could avoid months of extra treatment, reducing side effects and healthcare costs while maintaining cancer control.
- What could go wrong
- This is a Phase 2 trial with 120 participants, so results are preliminary. Active surveillance may lead to higher recurrence rates, and the study may not apply to all bladder cancer patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * 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: 1. No visible bladder tumor on cystoscopy; 2. Negative bladder biopsy and/or TURBT pathology; 3. Negative urine cytology; 4. Negative urinary tumor DNA (utDNA); 5. 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. Exclusion Criteria * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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General Hospital of Tianjin Medical University
Tianjin, China
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The Second Hospital of Tianjin Medical University
Tianjin, 300000, China
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Tianjin Hospital
Tianjin, China
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Xingtai People's Hospital
Xingtai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Lab-Grown tumor organoids could pick the right bladder chemo
- Can heated saline during bladder surgery stop tumors from coming back?
- Radiation instead of bladder removal: a new option for Hard-to-Treat bladder cancer?
- Can an immunotherapy plus chemotherapy keep High-Risk bladder cancer at bay?
- Can a bladder rinse before surgery keep bladder cancer at bay?
- Timing chemotherapy around bladder surgery may cut recurrence