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Safety and Efficacy 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 — ACCRUE  

Non-muscle Invasive Bladder Cancer Clinical Trial

Official title:
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Trial to Evaluate the Clinical Safety and Efficacy 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

Clinical Trial Summary

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

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04490993
Study type Interventional
Source Jiangsu Yahong Meditech Co., Ltd aka Asieris
Contact
Status Active, not recruiting
Phase Phase 3
Start date March 30, 2017
Completion date May 30, 2022
View Details
See also
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