LUCIANA SABOYA1,2, KEINI BUOSI1, TIAGO SILVA2, ELAINE CANDIDO1, JOSIANE MORARI3, LICIO A. VELLOSO3, SHAHROKH F. SHARIAT4,5,6,7, MARCUS V. SADI2, LEONARDO O. REIS1,8,9,*
Oncology Research, Vol.33, No.6, pp. 1495-1503, 2025, DOI:10.32604/or.2025.061812
- 29 May 2025
Abstract Objective: To determine the safety and the role of modulating cytokines and proteases in the immune response to intravesical Bacillus Calmette-Guérin (BCG) when primed with systemic intradermal BCG. Methods: Phase 1 and mechanistic longitudinal, prospective, single-blind randomized study (NCT04806178). Twenty-one non-muscle invasive urothelial bladder cancer patients undergoing intravesical adjuvant BCG after transurethral resection of bladder tumor (TURBT) in a teaching hospital between September 2021 and April 2023 were randomized to 0.1 mL of intradermal BCG vaccine or placebo (0.9% saline) administered 15 days before the start of intravesical BCG therapy. Blood samples were evaluated mechanistically… More >
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