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

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 hi

Trial Details

NCT ID
NCT06441110
Phase
PHASE3
Sponsor
Fujian Medical University Union Hospital
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Tislelizumab in Combination with Bacillus Calmette-Guérin
Locations (sample)
  • Fuzhou, Fujian, China|26.06139,119.30611

Key Eligibility Criteria

  • 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 C…
  • Performance status score (Eastern Cooperative Oncology Group, ECOG) of 0-2;

For full eligibility, visit ClinicalTrials.gov.

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