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

NCT07119996 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-08-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Tianxin Lin, Ph.D · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-02-01
Completion
2026-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07119996 on ClinicalTrials.gov