RecruitingPhase 3NCT06241755

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)


Sponsor

Chengdu CoenBiotech Co., Ltd

Enrollment

412 participants

Start Date

Dec 28, 2023

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and effectiveness of BCG bladder instillation therapy — a standard but important treatment where a weakened tuberculosis bacteria is placed into the bladder to stimulate the immune system against cancer — in Chinese patients with medium to high risk non-muscle invasive bladder cancer (NMIBC). This type of bladder cancer has not grown into the muscle wall and carries a meaningful risk of recurrence after surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with medium or high-risk non-muscle invasive bladder cancer (T1, Ta, or Tis stage) - You have had a complete transurethral resection of the bladder tumor (TURBt), with all visible tumor removed - A second TURBt procedure was performed or is planned if required by your condition - You are ready to begin BCG instillation therapy **You may NOT be eligible if...** - Your bladder cancer has grown into the muscle layer (muscle-invasive disease) - You have had other chemotherapy instillations recently (except specified agents) - You have contraindications to BCG therapy - You cannot complete the study follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBCG for Therapeutic Use

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.

DRUGBCG for Therapeutic Use

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)

Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06241755


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