NCT06241755

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 412 (estimated)
• Sponsor: Chengdu CoenBiotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Instillation of BCG for Therapeutic Use（BCG） into the urinary bladder (intravesical administration) improves rates of tumor recurrence and progression after adequate transurethral resection of bladder (TURBt) of moderate to high risk, non-muscle-invasive bladder cancer (NMIBC). To determine the efficacy and safety of BCG as an adjuvant therapy method in patients with NMIBC., we conduct a randomized, double-blinded, positive controlled phase 3 clinical trial. The target population is adults with moderate to high risk NMIBC (Ta ，T1 or tis) suitable for intravesical BCG treatment. Key eligibility criteria include prior transurethral resection of all visible tumor, adequate organ function, and ECOG performance status 0-2. 412 Subjects will be administrated with 120mg Intravesical BCG. The treatment includes Induction perfusion period (weekly x 6), followed by maintenance perfusion period (Q2W x 3 times ,then once monthly). totaled with 19 times BCG perfusion, and lasting until 1 year after surgery. The primary endpoint is 1-year recurrence-free survival rate.

Conditions

• Non-Muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	BCG 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.
DRUG	BCG 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.

Timeline

• Start date: 2023-12-28
• Primary completion: 2025-09-01
• Completion: 2026-09-03
• First posted: 2024-02-05
• Last updated: 2024-02-05

Locations

1 site across 1 country: China