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Tests treatment safety and results for Urinary Bladder Neoplasms
Official title Multicenter Clinical Trial on the Effectiveness and Safety of Instillation of BCG and Alternative BCG Protocols for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT06441110
What this study is testing
What is Tislelizumab in Combination with Bacillus Calmette-Guérin?
Tislelizumab in Combination with Bacillus Calmette-Guérin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for urinary bladder neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Previous studies have reported the efficacy of Bacillus Calmette-Guérin (BCG) combined with other drugs for the treatment of bladder cancer. However, research on the combination of tislelizumab and BCG for bladder cancer treatment has largely been retrospective.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntary participation in the trial with signed informed consent;
- Patients aged ≥18 and ≤75 years, regardless of gender, with an expected survival of ≥2 years;
- Histologically confirmed non-muscle-invasive bladder urothelial carcinoma with positive PD-L1 expression. According to the 2014 guidelines of the...
- Performance status score (Eastern Cooperative Oncology Group, ECOG) of 0-2;
- Completion of screening-related examinations (complete blood count, coagulation function, liver and kidney function, infectious disease screening...
You likely can't join if
- Any of the following conditions: Immune deficiency or impairment (such as AIDS patients), current use of immunosuppressive drugs or radiation therapy...
- Concurrent urogenital system tumors or tumors in other organs;
- Muscle-invasive bladder urothelial carcinoma (stage T2 and above) patients;
- Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation...
- Pregnant or lactating women, women of childbearing age not using effective contraception, or those planning to conceive during the trial period...
- Known or suspected intraoperative bladder perforation;
See the full eligibility criteria
- Voluntary participation in the trial with signed informed consent;
- Patients aged ≥18 and ≤75 years, regardless of gender, with an expected survival of ≥2 years;
- Histologically confirmed non-muscle-invasive bladder urothelial carcinoma with positive PD-L1 expression. According to the 2014 guidelines of the Chinese Urological Association (CUA), patients are assessed as having a...
- Performance status score (Eastern Cooperative Oncology Group, ECOG) of 0-2;
- Completion of screening-related examinations (complete blood count, coagulation function, liver and kidney function, infectious disease screening, 12-lead ECG, urinary system ultrasound, pelvic MR, and tissue pathology...
- Any of the following conditions: Immune deficiency or impairment (such as AIDS patients), current use of immunosuppressive drugs or radiation therapy that may cause systemic BCG disease reaction; allergy to BCG...
- Concurrent urogenital system tumors or tumors in other organs;
- Muscle-invasive bladder urothelial carcinoma (stage T2 and above) patients;
- Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation chemotherapy);
- Pregnant or lactating women, women of childbearing age not using effective contraception, or those planning to conceive during the trial period (including male participant partners);
- Known or suspected intraoperative bladder perforation;
- Presence of gross hematuria prior to enrollment, suspected unhealed surgical wounds or damaged urinary mucosa;
- Severe urethral stricture preventing cystoscopy, history of bladder contracture, or functional bladder volume less than 100mL;
- Accompanying cystitis, or those who have received other bladder instillation medications and have severe bladder irritation signs expected to affect the assessment of this study;
- Patients with various mental disorders, severe coagulation function, liver and kidney function, hematopoietic function disorders, etc., that cannot tolerate surgical treatment;
- Participation in other drug clinical trials within 3 months before enrollment;
- Known or suspected opioid or alcohol dependence;
- Any condition that the researcher believes may increase the risk to the participant or interfere with the execution of the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.