Actively Recruiting
Multicenter Clinical Trial on the Effectiveness and Safety of Instillation of BCG and Alternative BCG Protocols for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
Led by Fujian Medical University Union Hospital · Updated on 2024-06-04
76
Participants Needed
1
Research Sites
626 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Previous studies have reported the efficacy of Bacillus Calmette-Guérin (BCG) combined with other drugs for the treatment of bladder cancer. However, research on the combination of tislelizumab and BCG for bladder cancer treatment has largely been retrospective. Currently, ongoing clinical trials have not discussed the effectiveness of PD-1/PD-L1 inhibitors combined with BCG instillation in reducing postoperative recurrence in intermediate-risk NMIBC. Therefore, this study aims to explore the clinical efficacy and safety of tislelizumab combined with BCG in the treatment of intermediate and high-risk NMIBC. For this purpose, investigators have established strict screening criteria to include eligible patients in the study and have recruited suitable patients from multiple medical centers.Investigators have also developed a meticulous implementation process and follow-up considerations, hoping to better verify the clinical efficacy and safety of the combined use of these two drugs.
CONDITIONS
Official Title
Multicenter Clinical Trial on the Effectiveness and Safety of Instillation of BCG and Alternative BCG Protocols for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Age between 18 and 75 years with expected survival of at least 2 years
- Histologically confirmed non-muscle-invasive bladder urothelial carcinoma with positive PD-L1 expression and medium to high risk of recurrence or progression
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
- Completion of all screening examinations without surgical contraindications, including blood tests, coagulation, liver and kidney function, infectious disease screening, ECG, urinary ultrasound, pelvic MRI, and pathology
You will not qualify if you...
- Immune deficiency or impairment, current use of immunosuppressive drugs or radiation therapy causing systemic BCG disease reaction, or allergy to BCG components
- Fever, acute infectious diseases including active tuberculosis or undergoing anti-tuberculosis treatment
- Severe chronic cardiovascular, cerebrovascular diseases, or chronic kidney disease
- Presence of urogenital system tumors or other organ tumors
- Muscle-invasive bladder urothelial carcinoma (stage T2 or above)
- Chemotherapy, radiotherapy, or immunotherapy within 4 weeks before enrollment (except immediate postoperative bladder instillation chemotherapy)
- Pregnant or lactating women, women of childbearing age not using contraception, or planning pregnancy during the trial (including male participants' partners)
- Known or suspected bladder perforation during surgery
- Gross hematuria before enrollment, suspected unhealed surgical wounds, or damaged urinary mucosa
- Severe urethral stricture preventing cystoscopy, history of bladder contracture, or functional bladder volume below 100 mL
- Accompanying cystitis or severe bladder irritation from other bladder instillation medications
- Severe mental disorders or severe coagulation, liver, kidney, or hematopoietic dysfunctions preventing surgery
- Participation in other drug clinical trials within 3 months before enrollment
- Known or suspected opioid or alcohol dependence
- Any condition increasing participant risk or interfering with the trial as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Urology, Fujian Union Hospital, Fujian Medical University
Fuzhou, Fujian, China, 350000
Actively Recruiting
Research Team
J
Jiabing Zheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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