non-muscle- invasive bladder cancer
Conditions
Interventions
Test group:Continuous-circulation thermal perfusion chemotherapy using a bladder thermal perfusion therapy device (BR-PRG) and a single-use light-avoidance bladder thermal perfusion line (BR-PGGL-T/30
Control group:Ordinary bladder perfusion chemotherapy
Sponsors
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1)patients who did not undergo induction perfusion within 4 weeks after complete resection of the bladder tumor by TURBT (the last time will be the last time in the investigator's judgment); (2)patients whose risk of recurrence and prognosis of non-muscle invasive bladder cancer were grouped into the intermediate-risk group or high-risk group (for patients who had undergone multiple electrocutaneous biopsies, the pathology result was based on the higher-grade tumors); (3)patients who had a KPS score =80 and an expected survival of >30 months; (4)Pathologic examination suggesting non-muscle invasive uroepithelial carcinoma of the bladder; (5)Age =18 years and =80 years, male or female; (6)Voluntarily participate in this clinical trial and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1)Patients with carcinoma in situ of the bladder. (2)Combined with proven upper urinary tract or urethra tumor. (3)Combined bladder perforation, hematuria of the naked eye or grade 3-4 urinary tract infection. (4)Patients with discontinuous urethra, urethral stenosis or inability to use triple-lumen catheter normally, etc., which affects perfusion therapy. (5)Patients who have undergone partial cystectomy or have structural abnormalities of the bladder judged by the investigator to be inappropriate for perfusion therapy. (6)Patients with severe coagulation disorders. (7)History of allergy to the perfusion drug (gemcitabine). (8)History of pelvic radiation therapy, systemic chemotherapy or immunotherapy. (9)Known comorbid cardiovascular, hematopoietic, immune system and other serious diseases that, in the judgment of the investigator, make perfusion therapy inappropriate. (10)Patients with comorbid mental illness, drug abuse, alcoholism, or inability to cooperate. (11)Nursing, pregnant women or have a plan to have children in the near future. (12)Recurrent patients with a previous history of BCG or bladder thermal perfusion therapy. (13)Participation in other clinical trials 1 month prior to the trial. (14)Those with known vesicoureteral reflux. (15)In the opinion of the investigator, participation in this clinical trial is not appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year recurrence rate;Survival without recurrence;Time to Treatment Failure,TTF;Performance evaluation of device use (test group only);International Prostate Symptom Score (IPSS) and Bother of Score (BS); | — |
Countries
China
Contacts
Public ContactShuzhong Cui
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Outcome results
None listed