Non-Muscle Invasive Bladder Cancer Clinical Trial
Official title:
Phase III Multi-center Randomized, Double-blind and Positive-controlled Clinical Trial for Evaluating the Efficacy and Safety of BCG for Therapeutic Use in the Prevention of Postoperative Recurrence of Medium/High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
A phase III multi-center randomized, double-blind and positive-controlled clinical trial for evaluating the efficacy and safety of BCG for Therapeutic Use（BCG） in the prevention of postoperative recurrence of medium/high-risk non-muscle invasive bladder cancer (NMIBC).
Instillation of BCG for Therapeutic Use（BCG） into the urinary bladder (intravesical administration) improves rates of tumor recurrence and progression after adequate transurethral resection of bladder (TURBt) of moderate to high risk, non-muscle-invasive bladder cancer (NMIBC). To determine the efficacy and safety of BCG as an adjuvant therapy method in patients with NMIBC., we conduct a randomized, double-blinded, positive controlled phase 3 clinical trial. The target population is adults with moderate to high risk NMIBC (Ta ，T1 or tis) suitable for intravesical BCG treatment. Key eligibility criteria include prior transurethral resection of all visible tumor, adequate organ function, and ECOG performance status 0-2. 412 Subjects will be administrated with 120mg Intravesical BCG. The treatment includes Induction perfusion period (weekly x 6), followed by maintenance perfusion period (Q2W x 3 times ,then once monthly). totaled with 19 times BCG perfusion, and lasting until 1 year after surgery. The primary endpoint is 1-year recurrence-free survival rate. ;
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