To evaluate the clinical efficacy (median event-free survival) of APL-1202 in combination with Epirubicin hydrochloride versus Epirubicin hydrochloride alone in intermediate and high-risk chemo-refractory non-muscle invasive bladder cancer (NMIBC) patients
A multi-center, randomized, double-blind, placebo controlled Phase Ⅲ trial; including 3 stages: screening period, treatment period, and follow-up period. * Screening period: 6 weeks prior to treatment * Treatment period: * Induction period: APL-1202 is administered for 12 consecutive weeks * Maintenance period: after 12-week drug free period, APL-1202 is administered for another12 consecutive weeks as maintenance treatment * Follow up period: APL-1202 is administered at every 3-month interval if no events occurred in the treatment period and until the occurrence of events or the end of the entire clinical trial Intravesical Epirubicin hydrochloride will be administered once weekly for consecutive 6-8 weeks in the induction period, followed by once monthly in the maintenance period until end of 12 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
359
* Induction period: APL-1202 is administered for 12 consecutive weeks * Maintenance period: after 12-week drug free period, APL-1202 is administered for another12 consecutive weeks as maintenance treatment * Follow up period: APL-1202 is administered at every 3-month interval if no events occurred in the treatment period and until the occurrence of events or the end of the entire clinical trial Intravesical Epirubicin hydrochloride will be administered once weekly for consecutive 6-8 weeks in the induction period, followed by once monthly in the maintenance period until end of 12 months
* Induction period: placebo is administered for 12 consecutive weeks * Maintenance period: after 12-week drug free period, placebo is administered for another12 consecutive weeks as maintenance treatment * Follow up period: APL-1202 is administered at every 3-month interval if no events occurred in the treatment period and until the occurrence of events or the end of the entire clinical trial Intravesical Epirubicin hydrochloride will be administered once weekly for consecutive 6-8 weeks in the induction period, followed by once monthly in the maintenance period until end of 12 months
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Event-free survival
"Event"is defined as: pathologically confirmed recurrence, progression, or death resulting from bladder cancer
Time frame: Up to 30 months
Recurrent-free rate
Recurrent-free rate
Time frame: 24 months
Progression-free rate
Progression-free rate
Time frame: 24 months
Clinical benefit rate at 12,18, 24 months after enrollment (clinical benefits are defined as the pathological improvement of the recurrence, no high-risk recurrence, progression-free recurrence, no radical therapy and no death)
Clinical benefit rate at 12,18, 24 months after enrollment (clinical benefits are defined as the pathological improvement of the recurrence, no high-risk recurrence, progression-free recurrence, no radical therapy and no death)
Time frame: 24 months
Recurrence-free survival
Recurrence-free survival
Time frame: Up to 30 months
Progression-free survival
Progression-free survival
Time frame: Up to 30 months
Total survival
Total survival
Time frame: Up to 30 months
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