When bladder cancer patients are treated to mobilize their own immune system to fight the tumor, drugs that kill the bacteria can impair the effectiveness of the treatment. The purpose of this study is to find out if the common dietary supplement Vitamin B3 could allow drugs that kill bacteria to not negatively affect treatments that mobilize the immune system to fight tumors.
The patient voluntarily agrees to participate, is able to provide written informed consent, and is willing and able to comply with the protocol and schedule of assessments.
Aged ≥18 years on the date of signing the informed-consent form (ICF).
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix 1).
Residual tumour after TURBT and histologically confirmed urothelial carcinoma of the bladder staged cT2-T4a N0 M0 by AJCC 8th edition imaging; for mixed-histology tumours, the urothelial component must be predominant (≥50 %).
Previous therapy directed against PD-1, PD-L1, PD-L2, CTLA-4 or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
Systemic anticancer therapy or systemic immunomodulator (e.g. interferon, interleukin-2, TNF) within 28 days before enrolment.
Prior radiotherapy to the bladder.
≥12 months since the last dose of systemic chemotherapy before study neoadjuvant therapy;
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor