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Placebo + epirubicin is a combination regimen used as the control arm in the Phase 3 ACCRUE clinical trial for the treatment of intermediate and high-risk chemo-refractory non-muscle invasive bladder cancer (NMIBC). The regimen consists of an orally administered placebo and intravesically administered epirubicin hydrochloride. Epirubicin is a cytotoxic anthracycline antibiotic that exerts its antineoplastic effect by intercalating between DNA base pairs and inhibiting the enzyme topoisomerase II, thereby preventing DNA replication and RNA synthesis. In this specific trial context, the placebo is used to maintain the double-blind design while comparing the efficacy of a novel oral agent plus epirubicin against this standard-of-care chemotherapy control. The trial is sponsored by Jiangsu Yahong Meditech (Asieris).
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