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Prevention study for Non-Muscle Invasive Bladder Cancer
Official title Clinical Trial for Evaluating the Efficacy and Safety of BCG for Therapeutic Use in the Prevention of Postoperative Recurrence of Medium/High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
ClinicalTrials.gov ID: NCT06241755
What this study is testing
What is BCG for Therapeutic Use?
BCG for Therapeutic Use is an investigational medicine, given as an once-weekly, being studied as a potential treatment for non-muscle invasive bladder cancer.
Also referred to as BCG.
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
- A phase III multi-center randomized, double-blind and positive-controlled clinical trial for evaluating the efficacy and safety of BCG for Therapeutic Use（BCG） in the prevention of postoperative recurrence of medium/high-risk non-muscle invasive bladder cancer (NMIBC).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- 1\. Male or female patients aged ≥18 year and ≤75 year
- 2\. According to the stipulations of Guidelines on Diagnosing \& Treating Bladder Cancer (Edition 2022) as promulgated by National Health Commission...
- 3\. After a thorough TURBt, all tumors should be grossly invisible. Patients requiring a second procedure are also eligible for inclusion. Those...
- Criteria of a second TURBt: 1) Initial TURBt is insufficient; 2) No muscular specimen during an initial TURBt; 3) Stage T1 tumor; 4) G3 (advanced...
- A second TURBt is recommended within Weeks 2-6 after an initial procedure. It is optimal at Week 4. After TURBt until BCG bladder instillation, no...
You likely can't join if
- 1\. Current users of immune suppressants, hormones or radiotherapy and potentially causing systemic BCG-related disease responses (patients requiring...
- 2\. Allergic to BCG or its analogues;
- 3\. Presence of active TB lesions, currently receiving an anti-TB therapy or taking any anti-TB regimen within Month 6 prior to screening;
- 4\. Known or suspected intraoperative bladder perforation;
- 5\. Presence of severe gross hematuria pre-dosing as judged by investigators and with a suspicion of non-healing surgical wound;
- 6\. Presence of concurrent cystitis with such signs of cystic irritation as urinary frequency/urgency/pain as judged by investigators or previously...
See the full eligibility criteria
- 1\. Male or female patients aged ≥18 year and ≤75 year
- 2\. According to the stipulations of Guidelines on Diagnosing \& Treating Bladder Cancer (Edition 2022) as promulgated by National Health Commission, an initial definite diagnosis of medium/high-risk non-muscle invasive...
- 3\. After a thorough TURBt, all tumors should be grossly invisible. Patients requiring a second procedure are also eligible for inclusion. Those fulfilling the requirements of a second procedure may do so. Patients...
- Criteria of a second TURBt: 1) Initial TURBt is insufficient; 2) No muscular specimen during an initial TURBt; 3) Stage T1 tumor; 4) G3 (advanced grade) tumor, except for simple in situ tumor;
- A second TURBt is recommended within Weeks 2-6 after an initial procedure. It is optimal at Week 4. After TURBt until BCG bladder instillation, no other instillations are allowed except for 1st/2nd immediate...
- people undergoing a second TURBt and starting BCG therapy at Weeks 2-4 after a second procedure;
- Based upon the first/second result of histopathology examination, comprehensively evaluating whether or not a certain patient is eligible for inclusion.
- 4\. A previous history of never receiving any therapy of BCG bladder instillation;
- 5\. ECOG score: 0-2 points;
- 6\. Clinical laboratory tests fulfilling the following features:
- Blood routine: Within Day 14 prior to randomization, never using any hematopoietic growth factor or blood transfusion, including absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5×109/L; platelet ≥100000/mm3 or...
- Liver function: total serum bilirubin ≤1.5× upper limit of normal (ULN); for people with Gilbert syndrome total serum bilirubin \<3×ULN ;AST/ALT ≤2.5×ULN.
- Renal function: defined as estimated creatinine clearance ≥50 mL/min according to the formula of Cockcroft-Gault;
- Blood coagulation function: APTT ≤ 1.5×ULN and INR ≤1.5×ULN.
- 7\. Capable of understanding the procedures and methods of clinical study and participating voluntarily after offering thorough informed consents.
- 1\. Current users of immune suppressants, hormones or radiotherapy and potentially causing systemic BCG-related disease responses (patients requiring an injection of matching hormones after thyroidectomy or...
- 2\. Allergic to BCG or its analogues;
- 3\. Presence of active TB lesions, currently receiving an anti-TB therapy or taking any anti-TB regimen within Month 6 prior to screening;
- 4\. Known or suspected intraoperative bladder perforation;
- 5\. Presence of severe gross hematuria pre-dosing as judged by investigators and with a suspicion of non-healing surgical wound;
- 6\. Presence of concurrent cystitis with such signs of cystic irritation as urinary frequency/urgency/pain as judged by investigators or previously receiving therapies of other bladder instillation drugs and irritating...
- 7\. Individuals with a previous history of such severe adverse events as BCG sepsis or systemic infections;
- 8\. Complete cystic urinary incontinence is defined as using six and more pads with 24h;
- 9\. Concurrently with other urogenital system tumors or other malignant solid organ tumors;
- 10\. Individuals with a previous history of severe cerebrocardiovascular, pulmonary, hepatic and renal diseases or hypertension and diabetes mellitus clinically uncontrollable as judged by investigators;
- 11\. Individuals with an evidence of focal advanced or metastatic muscular infiltration urothelial cancer or concurrent extra-cystic non-muscle invasive urothelial transition cell cancer;
- 12\. Receiving chemotherapy, radiotherapy or immunotherapy within Week 4 prior to an initial dose (except for immediate postoperative intravesical chemotherapy);
- 13\. Pregnant or lactating women;
- 14\. Individuals failing to adopt effective birth control measures during study until Month 6 after the last dose;
- 15\. Participating in a clinical study of another drug within Month 3 prior to screening;
- 16\. Known dependents of opioids or alcohol;
- 17\. Any of the following items: Positive antibodies of (HIV, treponema pallidum and acute/chronic active hepatitis B (HBsAg); copy number of HBV-DNA in peripheral blood ≥103/mL; HCV antibody positive with copy number...
- 18\. Individuals with mental retardations or poor compliance;
- 19\. Any circumstance potentially boosting subject risks or interfering with study implementations as judged by investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 Guangzhou, Guangdong, 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.