BCG for Therapeutic Use Phase Ⅲ Clinical Trial
A Randomized, Double-blind, Active-controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of Therapeutic BCG for the Prevention of Postoperative Recurrence of Non-muscle-invasive Bladder Cancer in People Aged 18 Years and Older
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
438 participants
Apr 8, 2025
INTERVENTIONAL
Conditions
Summary
Research topic: A randomized, double-blind, active-controlled, multicenter phase III clinical trial evaluating the efficacy and safety of therapeutic BCG for the prevention of postoperative recurrence of non-muscle-invasive bladder cancer in people aged 18 years and older. The name of the drug: Bacillus Calmette-Guérin for treatment(BCG). Clinical indications: It is used for the treatment of bladder carcinoma in situ and the prevention of recurrence, and for the prevention of recurrence of bladder papilloma after transurethral resection in Ta or T1 stage. This product is not used for papillomas beyond the T1 stage. Study population: Patients aged 18 years and above with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) who have undergone transurethral bladder tumor resection. Objectives: Primary Objectives: To assess the effectiveness of BCG for therapeutic use in the adjuvant treatment of intermediate- and high-risk NMIBC after transurethral resection of bladder tumors. Secondary Purpose: To assess the safety of the therapeutic BCG vaccine in the adjuvant treatment of intermediate- and high-risk NMIBC after transurethral resection of bladder tumors. Other purposes: To assess the pharmacodynamic (PD) profile of BCG for therapeutic use in the adjuvant treatment of intermediate- and high-risk NMIBC after transurethral resection of bladder tumors. Study design: This study adopts a randomized, double-blind, active-controlled, multi-center trial design, including three phases: screening period, treatment period and follow-up period. In this study, 438 subjects will be randomly assigned to the experimental group and the control group in a 1:1 ratio, with 219 patients in both the experimental group and the control group, and stratified according to the baseline risk level (high-risk/intermediate-risk) and whether or not to perform urine PD sample collection (yes/no).
Eligibility
Plain Language Summary
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Interventions
After the subjects after transurethral bladder tumor resection were screened and randomly enrolled, the subjects were given intravesical infusion (experimental drug) within 2\~12 weeks after surgery, and perfused once a week for 6 consecutive times during the induction period; During the intensive phase, perfusion is given once every two weeks, 3 times in a row; During the maintenance period, perfusion was given once every 4 weeks, for a total of 19 perfusions, and the perfusion time continued until 1 year after surgery.
After the subjects after transurethral bladder tumor resection were screened and randomly enrolled, the subjects were administered intravesical infusion (control drug) within 2\~12 weeks after surgery, and perfused once a week for 6 consecutive times during the induction period; During the intensive phase, perfusion is given once every two weeks, 3 times in a row; During the maintenance period, perfusion was given once every 4 weeks, for a total of 19 perfusions, and the perfusion time continued until 1 year after surgery.
Locations(1)
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NCT06747455