Status:
RECRUITING
Investigation Into the Integration of Intracavitary Cryoablation and Immunotherapy in Bladder-Preserving Therapy
Lead Sponsor:
Changhai Hospital
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Professional Translation: This study is a single-center, prospective, non-randomized, parallel-controlled clinical trial initiated and conducted by the Department of Urology at the First Affiliated H...
Eligibility Criteria
Inclusion
- Age between 18 and 85 years old, gender not restricted;
- 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;
- The number of tumors is no more than 5;
- Have the intention to preserve the bladder;
- Voluntarily sign the informed consent form and be able to cooperate throughout the trial.
Exclusion
- 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;
- Preoperative imaging indicated hydronephrosis, pathology suggested carcinoma in situ or diagnostic TURBT indicated diffuse tumor growth during the procedure;
- Known to be allergic to chemotherapy drugs and/or immunotherapy drugs;
- Complicated with severe infectious diseases such as bacteremia and toxemia;
- Complicated with severe coagulation dysfunction;
- Suffering from serious diseases such as heart, brain, lung, liver, kidney, etc., and unable to tolerate surgery;
- Suffering from other malignant tumors;
- Pregnant or lactating women;
- Complicated with severe complications such as urethral stenosis that cannot tolerate cystoscopy surgery;
- Complicated with prohibited medications, including systemic anti-tumor drugs and immunosuppressants;
- Participating in other clinical trials simultaneously;
- Other situations that the investigator considers inappropriate for participating in this clinical trial.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07204132
Start Date
September 1 2025
End Date
September 1 2027
Last Update
October 2 2025
Active Locations (1)
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1
ChangHai Hospital
Shanghai, Shanghai Municipality, China, 200433