NCT07119996

Clinical Trial on the Protective Role of Vitamin B3 in Enhancing Immunotherapy for Bladder Cancer Patients

A Phase Ib Study Evaluating the Safety and Efficacy of Vitamin B3 Combined With Neoadjuvant Tislelizumab Plus Gemcitabine/Cisplatin in Antibiotic-Exposed Patients With cT2-T4aN0M0 Urothelial Carcinoma of the Bladder

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bladder (Urothelial, Transitional Cell) Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab, Cisplatin, Gemcitabine and Vitamin B3	1. Tislelizumab: 200mg, 1x time at d1 each cycle 2. Gemcitabine: 1000mg/ m2, in d1, d8 each cycle 3. Cisplatin: 70 mg/m2, in d2 each cycle Tislelizumab maintenance therapy: after chemoimmunotherapy, 200mg, q3W. 4. Vitamin B3 tablet(also known as nicotinic acid tablet) supplementation daily(300mg QD or 500mg QD) after antibiotic treatment.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-08-13
• Last updated: 2025-08-13