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

Launched by FUJIAN MEDICAL UNIVERSITY UNION HOSPITAL · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with intermediate and high-risk non-muscle invasive bladder cancer. The researchers want to see how well a combination of two medications—BCG, which is a type of immunotherapy vaccine, and tislelizumab, which helps the immune system fight cancer—works together to reduce the chances of the cancer coming back after treatment. This trial is important because previous studies mainly looked at these drugs separately or in different contexts, and now researchers want to specifically focus on their combined effect.

To join this study, participants need to be between 18 and 75 years old and have a confirmed diagnosis of bladder cancer that is considered medium to high risk for recurrence. They also need to be in good general health and can’t have certain conditions, like severe immune problems or other active cancers. Participants who enroll can expect to undergo various health checks to ensure they are suitable for the trial and will be monitored closely throughout the study to assess the treatment's safety and effectiveness. The trial is currently recruiting, so there are opportunities for eligible patients to take part in this important research.

Gender

ALL

Eligibility 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.

Trial Officials