Actively Recruiting
Phase III Randomized, Double-Blind Trial Evaluating BCG for Therapeutic Use to Prevent Recurrence of Medium/High-risk Non-Muscle Invasive Bladder Cancer
Led by Chengdu CoenBiotech Co., Ltd · Updated on 2024-02-05
412
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the effectiveness and safety of BCG for Therapeutic Use in preventing the return of medium to high-risk non-muscle invasive bladder cancer (NMIBC) after surgery. This phase III, multi-center, randomized, double-blind, and positive-controlled clinical trial focuses on adults aged 18 to 75 years who have undergone transurethral resection of bladder tumors (TURBt) and are suitable for intravesical BCG treatment. Participants will receive intravesical BCG treatment consisting of an induction phase with weekly instillations for six weeks, followed by a maintenance phase with instillations every two weeks for three times, then once every four weeks, totaling 19 treatments over one year. The BCG is administered by dissolving two vials into saline, instilling the solution into the bladder through a catheter, and having the patient change body positions to distribute the medication. Throughout the study, participants will be monitored for tumor recurrence and progression using clinical assessments and laboratory tests. The main outcome measured is the recurrence-free survival rate at one year. Additional follow-up includes evaluation of progression-free survival at one and two years. Safety and organ function will be regularly assessed, with the total study participation lasting one year after surgery.
CONDITIONS
Brief 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 or 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)
- Patients requiring a second TURBt procedure within 2 to 6 weeks after initial surgery may be included
- No previous BCG bladder instillation therapy
- ECOG performance status score of 0 to 2
- Adequate laboratory test results including blood counts, liver and kidney function, and blood coagulation within 14 days before randomization
- Ability to understand study procedures and provide informed consent
You will not qualify if you...
- Current use of immune suppressants, hormones, or radiotherapy causing systemic BCG-related responses
- Allergy to BCG or similar agents
- Active tuberculosis or anti-TB therapy within 6 months prior to screening
- Known or suspected bladder perforation during surgery
- Severe gross hematuria or non-healing surgical wounds
- Active cystitis or severe bladder irritation 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 organ tumors
- Uncontrolled severe cardiovascular, pulmonary, hepatic, renal diseases, hypertension, or diabetes
- Evidence of advanced or metastatic urothelial cancer
- Chemotherapy, radiotherapy, or immunotherapy within 4 weeks before first dose (except immediate postoperative chemotherapy)
- Pregnant or breastfeeding women
- Failure to use effective birth control during study and for 6 months after last dose
- Participation in another drug clinical trial within 3 months prior to screening
- Dependence on opioids or alcohol
- Positive for HIV, syphilis, active hepatitis B or C infections
- Mental retardation or poor compliance
- Any condition increasing risk or interfering with study as judged by investigators
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year after surgery
Participants receive intravesical BCG instillations as adjuvant therapy to prevent recurrence of bladder cancer. The treatment includes an induction phase followed by a maintenance phase.
19 BCG instillation visits: weekly for 6 weeks, then every 2 weeks for 3 visits, followed by once monthly visits
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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