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

NCT07119996 | Not Yet Recruiting Phase 1

• 1 other identifier: SYSU-20241202
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Antibiotics; Nicotinamide nucleotides; Immunotherapy; Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Phase I: The DLT dose of the Vitamin B3

  Participants with dose-limiting toxicity (DLT) asassessed by NCl CTC 5.0 and the administered drug dose.

  28 days after the first dose (D1-D28)

Secondary Outcomes (3)

• Percentage of Participants With Pathological Downstaging(pDS)

  24 Months

• Safety and AE

  24 months

• Percentage of Participants With Pathological Complete Response(pCR)

  24 months

Other Outcomes (1)

• Biomarker Endpoint Analyses

  24 months

Study Arms (1)

Vitamin B3 supplement

EXPERIMENTAL

Arm Description: During each 21 days study cycle(up to 6 cycles), all participants will receive: a) Tislelizumab: Taken 1x time at d1 each cycle or until it is determined participant must stop the drug. b) Gemcitabine: d1, d8 each cycle or until it is determined participant must stop the drug. c) Cisplatin: d2 each cycle or until it is determined participant must stop the drug. Tislelizumab maintenance therapy:after chemoimmunotherapy, q3W until it is determined participant must stop the drug, or 2 years of treatment is completed. d) Oral Vitamin B3 supplementation (2 predefined dose) intake

Drug: Tislelizumab, Cisplatin, Gemcitabine and Vitamin B3

Interventions

Tislelizumab, Cisplatin, Gemcitabine and Vitamin B3 DRUG

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.

Also known as: Nicotinic Acid Tablets, Tislelizumab, Cisplatin, Gemcitabine

Vitamin B3 supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 %).
• An infection occurring from 30 days to 1 day before the first dose of immuno-chemotherapy that, in the judgement of the attending physician, required oral or intravenous bactericidal antibiotics and met any of the following diagnostic criteria:
• Clinical features (e.g. ≥38.3 °C or sustained ≥38 °C for ≥1 h with chills, local pain, dysuria, etc.) plus laboratory evidence (WBC \> 10 × 10⁹/L or \< 4 × 10⁹/L, neutrophilia / neutropenia, markedly elevated CRP) consistent with bacterial infection;
• Abnormal urinalysis suggestive of urinary-tract infection (e.g. WBC \> 10/HPF, bacteria seen on high-power field, nitrite positive) with pathogen confirmed by urine culture;
• Infection confirmed by imaging or other microbiological tests (e.g. blood culture, nasopharyngeal swab, sputum culture).
• Permitted bactericidal antibiotics (oral or IV) include but are not limited to:
• β-lactams (penicillins, cephalosporins, carbapenems);
• Glycopeptides (vancomycin, teicoplanin);
• Quinolones (levofloxacin, ciprofloxacin);
• Aminoglycosides (gentamicin, streptomycin).
• Adequate organ function, documented within ≤14 days before enrolment:
• a. No growth-factor support ≤14 days before sampling and: i. Absolute neutrophil count ≥1.5 × 10⁹/L; ii. Platelets ≥90 × 10⁹/L; iii. Haemoglobin ≥90 g/L; b. INR or aPTT ≤1.5 × ULN; c. Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert's syndrome or isolated indirect hyper-bilirubinaemia of extra-hepatic origin); d. AST, ALT and alkaline phosphatase ≤2.5 × ULN; e. Pulmonary function adequate to tolerate major abdominal surgery.

You may not qualify if:

• Patients meeting any of the following are ineligible:
• 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.
• Prior antitumour drug therapy, except:
• ≥12 months since the last dose of systemic chemotherapy before study neoadjuvant therapy;
• Intravesical chemotherapy or immunotherapy completed ≥1 week before study treatment.
• Major surgery or significant trauma within 28 days before enrolment (vascular-access placement and TURBT are not major surgery).
• Live vaccine within 28 days before enrolment (inactivated seasonal influenza vaccine is permitted; intranasal influenza vaccine is live and prohibited).
• Active autoimmune disease requiring systemic therapy that, in the investigator's opinion, would interfere with study treatment.
• Long-term high-dose corticosteroids or other immunosuppressants that, in the investigator's opinion, would interfere with study treatment.
• Clinically significant abnormalities that could affect treatment, including electrolyte disturbance (K, Na, Ca), hypoalbuminaemia, interstitial lung disease, non-infectious pneumonitis, or other uncontrolled systemic diseases (e.g. diabetes, hypertension, cardiovascular disease such as severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, or clinically significant ventricular arrhythmia within 6 months).
• Untreated chronic HBV infection with HBV-DNA ≥500 IU/mL (2,500 copies/mL) or HBsAg carrier status. Patients with inactive HBsAg carriage or stable active HBV on antiviral therapy with HBV-DNA \< 500 IU/mL may enrol. HBV-DNA testing is required only for anti-HBc-positive patients.
• Active HCV infection. Patients who are anti-HCV-negative, or anti-HCV-positive but HCV-RNA-negative, may enrol. Anti-HCV-positive patients must have HCV-RNA testing.
• History of immunodeficiency (including HIV positivity or other acquired/congenital immunodeficiencies), or prior allogeneic stem-cell or solid-organ transplantation (Appendix 3).

Sponsors & Collaborators

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

MeSH Terms

Conditions

Neoplasms; Urinary Bladder Neoplasms

Interventions

tislelizumab; Cisplatin; Gemcitabine; Niacinamide; Niacin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Study Officials

• Tianxin Lin, Ph.D

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

  STUDY CHAIR

Central Study Contacts

Daqin Wu, Ph.D

CONTACT

020-81338949; wudq23@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: October 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08