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Bladder (Urothelial, Transitional Cell) CancerPhase 1NCT07119996

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

A Phase 1 study testing Tislelizumab, Cisplatin, Gemcitabine and Vitamin B3 in people with Bladder (Urothelial, Transitional Cell) Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tislelizumab, Cisplatin, Gemcitabine and Vitamin B3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
1 Aug 2025to 1 Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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:
  • 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.
  • Considered cisplatin-eligible by the investigator. Patients deemed cisplatin-ineligible must meet ≥1 of: ECOG > 1 or Karnofsky 60-70 %; creatinine clearance < 60 mL/min; NCI-CTCAE v5.0 grade ≥2 hearing loss; NCI-CTCAE v5.0 grade ≥2 peripheral neuropathy; New York Heart Association class III or IV heart failure.
  • Women of child-bearing potential agree to use highly effective contraception during the study and for ≥120 days after the last dose of tislelizumab or chemotherapy (whichever is later) and have a negative urine or serum pregnancy test ≤7 days before enrolment. Non-sterilised men likewise agree to use highly effective contraception for the same period (Appendix 5).

Who cannot join

  • 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;
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  • 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).
  • Known hypersensitivity to other monoclonal antibodies.
  • Known hypersensitivity to any study drug or excipient.
  • Unresolved toxicities from prior therapy that have not returned to baseline or stabilised, unless considered by the investigator not to pose a safety risk (e.g. alopecia, neuropathy, certain laboratory abnormalities).
  • Any condition (medical or substance abuse) that could impede study-drug administration, confound interpretation of results, or place the patient at high risk of complications.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Daqin Wu, Ph.D contact

020-81338949

wudq23@mail2.sysu.edu.cn

China1 site, 1 recruiting

  • Sun-Yatsen Memorial Hospital

    Guangzhou, Guangdong, 510260

    Daqin Wu, PhD, 020-52193348, wudq23@mail2.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Being tested
Tislelizumab, Cisplatin, Gemcitabine and Vitamin B3
Keywords
Antibiotics, Nicotinamide nucleotides, Immunotherapy, Bladder Cancer
Medical subject headings
Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tislelizumab, Cisplatin, Gemcitabine and Vitamin B3Drug

    Also called Nicotinic Acid Tablets, Tislelizumab, Cisplatin, Gemcitabine

    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.
Study groups in NCT07119996
Study groupRoleWhat they receive
Vitamin B3 supplementExperimentalArm 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
Receives: Drug: Tislelizumab, Cisplatin, Gemcitabine and Vitamin B3

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 28 days after the first dose (D1-D28)

Secondary outcomes (3)

  1. Percentage of Participants With Pathological Downstaging(pDS)

    The pathological downstaging rate is defined as the evaluation of whether the staging is degraded to ≤ T2 based on the post-surgery pathological findings. The rates of cT2N0 → pT0N0, cT3-4aN0 → pT0N0, cT2N0 → ≤ pT1N0, cT3-4aN0 → ≤ pT1N0 will be calculated, and the 2 sided Clopper-Pearson 95% confidence interval (CI) of pathological downstaging rate will be calculated to assess the precision of the estimated pathological downstaging rate.

    Measured: 24 Months

  2. Safety and AE

    Number of unique patients who had a treatment-related (possible, probable, or definite) adverse event using the Medical Dictionary for Regulatory Activities (MedDRA) terms and graded per NCI-CTCAE v5.0. Number and Grade of patients who had a surgery-related adverse event (surgery-related AE) will be measured according to the Clavien-Dindo classification.

    Measured: 24 months

  3. Percentage of Participants With Pathological Complete Response(pCR)

    Pathological evaluation of the resected tumor tissue and regional lymph nodes showed no residual tumor cells, complete disappearance of the tumor lesions, and no evidence of new lesions.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2025
  2. Study start1 Aug 2025
  3. Primary completion1 Feb 2026
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07119996
Sponsor's protocol ID
SYSU-20241202
Status last verified
Aug 2025
First submitted
6 Aug 2025
Last updated
30 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tislelizumab, Cisplatin, Gemcitabine and Vitamin B3 in people with Bladder (Urothelial, Transitional Cell) Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daqin Wu, Ph.D (020-81338949, wudq23@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: The DLT dose of the Vitamin B3 (time frame: 28 days after the first dose (D1-D28)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07119996.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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