Clinical Application of a Novel Endoscopic Cryoablation Technique Combined With Immunotherapy (TECIC Model) in Bladder-Preserving Therapy for Bladder Cancer
Condition: Bladder Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT07204132
Sponsor: Changhai Hospital
Eligibility:
- Age: minimum 18 Years maximum 85 Years
- Gender: All
Inclusion Criteria:
- 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 Criteria:
- 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.
View trial on ClinicalTrials.gov