Actively Recruiting
Multicentre Clinical Trial of the Efficacy and Safety of Tislelizumab with BCG Instillation for Preventing Recurrence in 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
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the combination of tislelizumab and Bacillus Calmette-Guérin (BCG) instillation as a treatment for intermediate and high-risk non-muscle invasive bladder cancer (NMIBC). This Phase 3 clinical trial aims to explore the clinical effectiveness and safety of this combined therapy in reducing postoperative recurrence, addressing a gap in current research which has mostly been retrospective regarding PD-1/PD-L1 inhibitors with BCG. Participants receive postoperative immediate instillation of epirubicin followed by intravenous tislelizumab every three weeks for one year. Additionally, eligible patients start BCG instillation two weeks after surgery, undergoing a 6-week induction phase of weekly BCG treatments, followed by three biweekly instillations, and then ten monthly maintenance instillations. This detailed regimen is designed to evaluate the combined treatment's impact on cancer recurrence. Throughout the study, participants undergo regular postoperative cystoscopic and pathological examinations to monitor tumor recurrence and progression for up to 60 months. Researchers assess relapse-free survival as the primary outcome, alongside progression-free survival, overall survival, and adverse events. The study enrolls patients from multiple medical centers and includes extensive screening and follow-up to ensure safety and accurate evaluation of treatment effects.
CONDITIONS
Brief 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 regardless of gender, with expected survival of 2 years or more
- Histologically confirmed non-muscle-invasive bladder urothelial carcinoma with positive PD-L1 expression
- Assessed as intermediate to high risk of recurrence or progression per 2014 Chinese Urological Association guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Completed required screening exams without surgical contraindications
You will not qualify if you...
- Immune deficiency or impairment, current use of immunosuppressive drugs or radiation causing systemic BCG reaction
- Allergy to BCG components or active infectious diseases including tuberculosis
- Severe chronic cardiovascular, cerebrovascular, or kidney diseases
- Concurrent urogenital or other organ tumors
- Muscle-invasive bladder cancer (stage T2 or higher)
- Chemotherapy, radiotherapy, or immunotherapy within past 4 weeks (excluding immediate postoperative bladder instillation chemotherapy)
- Pregnant, lactating, or women not using effective contraception during trial
- Known or suspected bladder perforation during surgery
- Gross hematuria, unhealed surgical wounds, or damaged urinary mucosa
- Severe urethral stricture, bladder contracture, or functional bladder volume under 100 mL
- Accompanying cystitis or severe bladder irritation affecting assessment
- Severe mental disorders or organ dysfunction preventing surgery
- Participation in other drug trials within 3 months
- Known or suspected opioid or alcohol dependence
- Any condition increasing participant risk or interfering with trial execution
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive postoperative immediate instillation of epirubicin (50mg), followed by intravenous tislelizumab every 3 weeks for up to one year. BCG instillation starts 2 weeks after surgery, beginning with weekly instillations for 6 weeks, then every 2 weeks for three instillations, followed by monthly maintenance instillations for ten months.
Weekly visits for 6 weeks, then visits every 2 weeks for 3 instillations, followed by monthly visits for 10 months
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
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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