Endoluminal cryoablation plus immunotherapy to preserve the bladder in high-risk NMIBC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, non-randomized, parallel-controlled trial at Changhai Hospital recruiting adults (18–85) with biopsy- or TURBT-confirmed high-risk non-muscle-invasive bladder cancer who wish to preserve their bladder. The experimental arm receives TURBT plus a novel endoluminal precise cryoablation technique followed by postoperative immunotherapy and metronomic chemotherapy (the TECIC model), while the control arm receives conventional surgical treatment. Investigators will track safety, tumor recurrence, and bladder-preservation outcomes over the planned July 2025–July 2027 execution period. Key eligibility limits include ≤5 tumors and exclusion of patients with organ involvement, lymph node or distant metastasis, hydronephrosis, or carcinoma in situ.

Why it matters

Who can join: the full rules

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.

Where it's running

• ChangHai Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Shuxiong Zeng
• Email: zengshuxiong@126.com
• Phone: 86-18930568759

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.