Actively Recruiting
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)
Led by Chengdu CoenBiotech Co., Ltd · Updated on 2024-02-05
412
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
Sponsors
C
Chengdu CoenBiotech Co., Ltd
Lead Sponsor
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 75 years
- Diagnosed with medium/high-risk non-muscle invasive urothelial bladder cancer (T1/Ta/Tis) confirmed by histology
- All visible tumors removed by thorough transurethral resection of bladder tumor (TURBt); second TURBt allowed if indicated
- No prior BCG bladder instillation treatment
- ECOG performance status of 0 to 2
- Clinical laboratory tests within defined normal limits for blood counts, liver function, kidney function, and coagulation
- Able to understand and voluntarily consent to study procedures
You will not qualify if you...
- Current use of immune suppressants, hormones, or radiotherapy that may cause systemic BCG-related reactions
- Allergic to BCG or its analogues
- Active tuberculosis lesions or anti-TB treatment within 6 months prior to screening
- Known or suspected bladder perforation during surgery
- Severe gross hematuria or suspected non-healing surgical wound before dosing
- Active cystitis or severe bladder irritation symptoms interfering with evaluations
- History of severe BCG sepsis or systemic infections
- Complete urinary incontinence requiring six or more pads per day
- Other urogenital or malignant solid tumors
- Severe uncontrolled cerebrocardiovascular, pulmonary, hepatic, renal diseases, hypertension, or diabetes
- Advanced or metastatic urothelial cancer or concurrent extra-cystic non-muscle invasive cancer
- Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to initial dose (except immediate postoperative chemotherapy)
- Pregnant or breastfeeding women
- Not using effective birth control during study through 6 months after last dose
- Participation in another drug clinical trial within 3 months prior to screening
- Known dependence on opioids or alcohol
- Positive for HIV, treponema pallidum, active hepatitis B or C infections beyond defined thresholds
- Mental retardation or poor compliance
- Any condition increasing risk or interfering with study as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
J
Jian Huang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here