Freeze, then boost: novel combo could spare bladders from removal
NCT ID NCT07204132
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new approach to treat high-risk bladder cancer without removing the bladder. Doctors will first remove the tumor through the urethra, then freeze the tumor base with a special balloon, followed by immunotherapy and low-dose chemotherapy. The goal is to see if this combination can keep the cancer from coming back and help patients live longer, while preserving their bladder and quality of life. The trial plans to enroll 180 patients in China.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cryoablation (freezing) plus anti-PD-1 immunotherapy (e.g., Camrelizumab, Tislelizumab) and chemotherapy (Gemcitabine + Cisplatin)
- What this could lead to
- If successful, this could offer a less invasive, bladder-sparing treatment option that reduces recurrence and improves survival for patients with high-risk bladder cancer.
- What could go wrong
- This is an early-stage, non-randomized study with only 180 patients, so results may not apply broadly. The combination therapy also carries risks of side effects from immunotherapy and chemotherapy.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Sep 2027
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 to 85 years
- 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: 1. Age between 18 and 85 years old, gender not restricted; 2. Clinically diagnosed as patients with bladder tumors, and classified as high-risk non-muscle-invasive bladder cancer through biopsy or TURBT staging. \* High-risk non-muscle bladder cancer is defined as meeting any of the following criteria: ① T1 stage tumor; ② High-grade urothelial carcinoma; ③ Simultaneously meeting: multiple, recurrent and diameter \> 3cm bladder cancer; 3. The number of tumors is no more than 5; 4. Have the intention to preserve the bladder; 5. Voluntarily sign the informed consent form and be able to cooperate throughout the trial. Exclusion Criteria: 1. Preoperative imaging indicated involvement of organs around the bladder (such as ureters, prostate, rectum, etc.), the pelvic or abdominal wall, or lymph node metastasis (N1) and distant metastasis (M1) stage; 2. Preoperative imaging indicated hydronephrosis, pathology suggested carcinoma in situ or diagnostic TURBT indicated diffuse tumor growth during the procedure; 3. Known to be allergic to chemotherapy drugs and/or immunotherapy drugs; 4. Complicated with severe infectious diseases such as bacteremia and toxemia; 5. Complicated with severe coagulation dysfunction; 6. Suffering from serious diseases such as heart, brain, lung, liver, kidney, etc., and unable to tolerate surgery; 7. Suffering from other malignant tumors; 8. Pregnant or lactating women; 9. Complicated with severe complications such as urethral stenosis that cannot tolerate cystoscopy surgery; 10. Complicated with prohibited medications, including systemic anti-tumor drugs and immunosuppressants; 11. Participating in other clinical trials simultaneously; 12. Other situations that the investigator considers inappropriate for participating in this clinical trial.
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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
1 site. 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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ChangHai Hospital
RECRUITINGShanghai, Shanghai Municipality, 200433, 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 tumor genes decide who keeps their bladder?
- Lab-Grown tumor models could match patients to the right cancer drug
- Can heated saline during bladder surgery stop tumors from coming back?
- Can a radioactive antibody light up hidden tumors on PET scans?
- Can a radioactive drug seek out and attack solid tumors?