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

Clinical Application of a Novel Endoscopic Cryoablation Technique Combined With Immunotherapy (TECIC Model) in Bladder-Preserving Therapy for Bladder Cancer

This trial will try combining precise endoscopic cryoablation with TURBT, immunotherapy, and low‑dose (metronomic) chemotherapy to help people with high‑risk non‑muscle‑invasive bladder cancer keep their bladder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Camrelizumab, Tislelizumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07204132 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–85 with high‑risk non‑muscle‑invasive bladder cancer confirmed by biopsy or TURBT, with no more than five tumors and no imaging evidence of organ or distant spread, who want to preserve their bladder.

Not a fit: Patients with imaging evidence of adjacent‑organ involvement, pelvic wall or nodal/distant metastasis, hydronephrosis, or carcinoma in situ are unlikely to benefit from this bladder‑preserving approach.

Why it matters

Potential benefit: If successful, the TECIC approach could allow more patients with high‑risk NMIBC to retain their bladder with controlled disease and fewer life‑altering consequences than radical cystectomy.

How similar studies have performed: While TURBT and immunotherapy are established in bladder cancer and cryoablation has precedent in other organs, the integrated endoluminal cryoablation plus immunotherapy (TECIC) approach for bladder preservation is relatively novel with limited direct prior evidence.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• ChangHai Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Shuxiong Zeng

Conditions Bladder Cancer; TECIC Model; Immunotherapy; Endoscopic Cryoablation Technique