Clinical trial NCT06441110: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Urinary Bladder Neoplasms
BCG Vaccine
Immunotherapy, Active
Multicenter Study
Treatment Outcome
Neoplasm Recurrence, Local
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Relapse-Free Survival(RFS)
timeFrame: From date of postoperative cystoscopic examination to the first documented recurrence of bladder tumor,assessed up to 60 months.
Secondary outcomes:
measure: Progression-Free Survival(PFS)
timeFrame: From date of postoperative cystoscopic and pathological examinations to the first progression of bladder tumor, assessed up to 60 months.
measure: Overall survival
timeFrame: From date of post-surgery to the time of death due to any cause,assessed up to 60 months
measure: Adverse event（AS)
timeFrame: From date of post-surgery to the time of death due to any cause,assessed up to 60 months.
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Urology, Fujian Union Hospital, Fujian Medical University
state: Fujian
Study officials:
affiliation: Department of Urology, Fujian Union Hospital, Fujian Medical University
name: Zhenlin Chen
role: PRINCIPAL_INVESTIGATOR
References: