The purpose of this study is to determine the efficacy and safety of Hyperthermic Intravesical Chemotherapy (HIVEC) with Gemcitabine (GEM) after Transurethral Resection of Bladder Tumors (TURBT) in the treatment of medium or high-risk group Non-Muscle-Invasive Bladder Cancer (NMIBC).
Patients who did not receive induction perfusion within 4 weeks after complete resection of bladder tumor with TURBT (Patients who were judged by the investigator to be in need of secondary electrotomy, for the last time).
Recurrence risk and prognosis of Non-Muscle-Invasive Bladder Cancer were divided into medium-risk group or high-risk group (patients who underwent multiple electrosurgical biopsies, and the pathological results were based on higher grade tumors).
KPS score ≥80, expected survival > 30 months.
Pathological suggested non-myoinvasive urothelial carcinoma of the bladder.
Patients with bladder cancer in situ.
Combined with proven upper urinary tract or urethral tumors.
The patients were complicated with bladder perforation, gross hematuria or urinary tract infection of grade 3-4.
Patients with urethral discontinuity, urethral stricture, or inability to use a three lumen catheter normally affect perfusion therapy.
Parallel
TURBT
Procedure/SurgeryTransurethral Resection of Bladder Tumors
HIVEC
Procedure/SurgeryHyperthermic Intravesical Chemotherapy with Gemcitabine (3g/150ml NS) at 45 °C for 60 minutes. Induction perfusion was required to start within 4 weeks, once a week (±5 days) for 6 to 8 times. After the last induction infusion, maintenance infusion was performed, once every month (±2 weeks) for 1 year from the first induction infusion.
Intravesical Chemotherapy
Procedure/SurgeryIntravesical Chemotherapy with Gemcitabine (3g/150ml NS). Induction perfusion was required to start within 4 weeks, once a week (±5 days) for 6 to 8 times. After the last induction infusion, maintenance infusion was performed, once every month (±2 weeks) for 1 year from the first induction infusion.
Gemcitabine
DrugGemcitabine (3g/150ml NS).
Recurrence rate
The patients were observed for 2 years since they received HIVEC or intravesical chemotherapy，and cystoscopy was repeated every 3 months. If a new tumor-like organism is seen under the microscope, and pathology indicates urothelial carcinoma of the bladder after TURBT or cystoscopic biopsy, the tumor is considered to have recurred. 2-year recurrence rate = number of recurrence cases within 2 years / total number of enrolled cases \* 100%.
1-year recurrence rate
1-year recurrence rate = number of recurrence cases within 1 years / total number of enrolled cases \* 100%.
Recurrence-free survival (RFS) rate
Recurrence free survival is calculated from the date of randomization to the date of record recurrence or death from any cause, whichever occurred first.
Time to treatment failure
Time to treatment failure is calculated from the date of randomization to the date of treatment discontinuation/termination, including any reason for discontinuation/termination, such as disease progression, death, withdrawal due to adverse events, subject's refusal to continue the study, or use of a new treatment.
Success rate of therapeutic operation
Success rate of therapeutic operation
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
