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)
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)
Chengdu CoenBiotech Co., Ltd
412 participants
Dec 28, 2023
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Plain Language Summary
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Interventions
Specification: 60 mg (6.0×10\^7 CFU)/vial, each vial contains BCG 60 mg and each mg BCG shall have a count of live bacteria not less than 1.0×10\^6 CFU. Usage \& dosage: Dissolving two vials (120 mg) into 40-50 mL normal saline and shaking thoroughly. Following the procedures of surgical cauterization, inserting a Foley tube into cystic cavity and instilling diluted drug solution. After instillation, constantly changing body positions of a patient, such as left/right recumbent and supine/prostrate. Each position is maintained for around 30 min. Self-discharging drug solution after 2h.
Specification: 60 mg/vial with a count of live BCG bacteria not less than 1.0×10\^6 CFU/mg. Usage \& dosage: Dissolving two vials (120 mg) into 40-50 mL normal saline and shaking thoroughly. Following the procedures of surgical cauterization, inserting a Foley tube into cystic cavity and instilling diluted drug solution. After instillation, constantly changing body positions of a patient, such as left/right recumbent and supine/prostrate. Each position is maintained for around 30 min. Self-discharging drug solution after 2h.
Locations(1)
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NCT06241755