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.
Voluntary participation in the trial with signed informed consent;
Patients aged ≥18 and ≤75 years, regardless of gender, with an expected survival of ≥2 years;
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);
Performance status score (Eastern Cooperative Oncology Group, ECOG) of 0-2;
Concurrent urogenital system tumors or tumors in other organs;
Muscle-invasive bladder urothelial carcinoma (stage T2 and above) patients;
Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation chemotherapy);
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);