Effect of BCG and Tislelizumab on Bladder Cancer
Multicentre Clinical Trial of the Efficacy and Safety of Tislelizumab in Combination With BCG Bladder Instillation in the Prevention of Postoperative Recurrence in Intermediate and High-risk Non-muscle Invasive Bladder Cancer
This study is testing if combining a vaccine called BCG with a new drug called tislelizumab can help people with intermediate and high-risk bladder cancer have fewer recurrences after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fujian Medical University Union Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, tislelizumab |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06441110 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of combining Bacillus Calmette-Guérin (BCG) with the PD-1 inhibitor tislelizumab for treating intermediate and high-risk non-muscle invasive bladder cancer (NMIBC). The study aims to address gaps in previous research by focusing on the clinical efficacy of this combination therapy in reducing postoperative recurrence. Eligible patients will be recruited from multiple medical centers, and strict screening criteria will be applied to ensure the selection of suitable candidates. The trial will involve comprehensive follow-up to assess treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed non-muscle-invasive bladder urothelial carcinoma and positive PD-L1 expression.
Not a fit: Patients with low-risk bladder cancer or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with intermediate and high-risk non-muscle invasive bladder cancer.
How similar studies have performed: While previous studies have explored BCG's efficacy, the combination with PD-1 inhibitors like tislelizumab is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntary participation in the trial with signed informed consent; 2. Patients aged ≥18 and ≤75 years, regardless of gender, with an expected survival of ≥2 years; 3. Histologically confirmed non-muscle-invasive bladder urothelial carcinoma with positive PD-L1 expression. According to the 2014 guidelines of the Chinese Urological Association (CUA), patients are assessed as having a medium to high risk of recurrence or progression. (For patients considering a second transurethral resection, they may be included in the study after completing the procedure and if pathology confirms medium to high risk non-muscle-invasive bladder urothelial carcinoma); 4. Performance status score (Eastern Cooperative Oncology Group, ECOG) of 0-2; 5. Completion of screening-related examinations (complete blood count, coagulation function, liver and kidney function, infectious disease screening, 12-lead ECG, urinary system ultrasound, pelvic MR, and tissue pathology examination), without surgical contraindications. Exclusion Criteria: 1. Any of the following conditions: Immune deficiency or impairment (such as AIDS patients), current use of immunosuppressive drugs or radiation therapy that may cause systemic BCG disease reaction; allergy to BCG components; patients with fever and acute infectious diseases, including active tuberculosis or those undergoing anti-tuberculosis treatment; those with severe chronic cardiovascular or cerebrovascular diseases or chronic kidney disease; 2. Concurrent urogenital system tumors or tumors in other organs; 3. Muscle-invasive bladder urothelial carcinoma (stage T2 and above) patients; 4. Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation chemotherapy); 5. Pregnant or lactating women, women of childbearing age not using effective contraception, or those planning to conceive during the trial period (including male participant partners); 6. Known or suspected intraoperative bladder perforation; 7. Presence of gross hematuria prior to enrollment, suspected unhealed surgical wounds or damaged urinary mucosa; 8. Severe urethral stricture preventing cystoscopy, history of bladder contracture, or functional bladder volume less than 100mL; 9. Accompanying cystitis, or those who have received other bladder instillation medications and have severe bladder irritation signs expected to affect the assessment of this study; 10. Patients with various mental disorders, severe coagulation function, liver and kidney function, hematopoietic function disorders, etc., that cannot tolerate surgical treatment; 11. Participation in other drug clinical trials within 3 months before enrollment; 12. Known or suspected opioid or alcohol dependence; 13. Any condition that the researcher believes may increase the risk to the participant or interfere with the execution of the clinical trial.
Where this trial is running
Fuzhou, Fujian
- Department of Urology, Fujian Union Hospital, Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Zhenlin Chen — Department of Urology, Fujian Union Hospital, Fujian Medical University
- Study coordinator: Jiabing Zheng
- Email: xhyykjk@163.com
- Phone: +8613799422519
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.