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:

  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.

View trial on ClinicalTrials.gov