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Tests treatment safety and results for Non-Muscle-Invasive Bladder Cancer (NMIBC)
Official title Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients
ClinicalTrials.gov ID: NCT06696794
What this study is testing
What is Mitomycin C (MMC)?
Mitomycin C (MMC) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-muscle-invasive bladder cancer (nmibc).
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
- The goal of this clinical trial is to learn if neoadjuvant intravesical instillation of mitomycin C combined with en-bloc surgery works to treat high-risk non-muscle-invasive bladder cancer (NMIBC) patients. It will also learn about the safety of neoadjuvant intravesical instillation of mitomycin C.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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
- Voluntarily sign an informed consent form, understand the study and are willing and able to follow and complete all trial procedures
- Gender is not limited, age between 18 to 75 years old (inclusive of boundary values)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Previously confirmed non-muscle-invasive bladder cancer by imaging and pathology
- In accordance with the "EAU Guidelines (2024 edition)" high-risk NMIBC patient danger grouping. All T1 HG/G3 and CIS patients except for the...
You likely can't join if
- The primary tumor is upper urinary tract urothelial carcinoma of the renal pelvis and ureter
- Patients who have suffered from malignant tumors other than bladder urothelial carcinoma within 5 years before enrollment. However, the following...
- Patients with active autoimmune diseases who have required systemic treatment (i.e., long-term use of corticosteroids or immunosuppressive drugs)...
- Patients who are expected to have major surgery during the study period or who have undergone major surgery within 4 weeks before dosing and have not...
- Any immune-related toxicity caused by previous cancer treatments has not recovered to ≤Grade 1 (except for Grade 2 endocrine disorders on stable dose...
- Patients who are seropositive for Human Immunodeficiency Virus (HIV) or have a history of HIV infection or other acquired immunodeficiency diseases
See the full eligibility criteria
- Voluntarily sign an informed consent form, understand the study and are willing and able to follow and complete all trial procedures
- Gender is not limited, age between 18 to 75 years old (inclusive of boundary values)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Previously confirmed non-muscle-invasive bladder cancer by imaging and pathology
- In accordance with the "EAU Guidelines (2024 edition)" high-risk NMIBC patient danger grouping. All T1 HG/G3 and CIS patients except for the extremely high-risk group; Ta LG/G2 or T1G1, non-CIS with three risk factors...
- Participants are willing to provide the last cystoscopy biopsy specimen or specimens from the previous recurrence surgery (including paraffin blocks, paraffin-embedded sections, etc.)
- The interval between previous anti-tumor treatments (chemotherapy, radiotherapy, immunotherapy) and the first administration of this trial is ≥6 weeks
- Suitable organ function and hematopoietic function: Neutrophil count (NEUT ≥ 1.5 × 10\^9/L; White blood cell count (WBC) ≥ 3.0 × 10\^9/L; Platelet count ≥ 100 × 10\^9/L; Hemoglobin ≥ 90g/L; Serum creatinine ≤ 1.5 times...
- Male participants must agree to use effective contraceptive measures during the treatment period and for at least 180 days after the last treatment, and must not donate sperm during this period; women of childbearing...
- The primary tumor is upper urinary tract urothelial carcinoma of the renal pelvis and ureter
- Patients who have suffered from malignant tumors other than bladder urothelial carcinoma within 5 years before enrollment. However, the following patients are included (eligible for enrollment): ① Patients with locally...
- Patients with active autoimmune diseases who have required systemic treatment (i.e., long-term use of corticosteroids or immunosuppressive drugs) within the past two years. Replacement therapy (such as thyroid hormone...
- Patients who are expected to have major surgery during the study period or who have undergone major surgery within 4 weeks before dosing and have not fully recovered
- Any immune-related toxicity caused by previous cancer treatments has not recovered to ≤Grade 1 (except for Grade 2 endocrine disorders on stable dose steroid replacement therapy), and/or any other toxicity related to...
- Patients who are seropositive for Human Immunodeficiency Virus (HIV) or have a history of HIV infection or other acquired immunodeficiency diseases
- Patients who require long-term antiviral medication for hepatitis B or C, where hepatitis B (must meet both HBsAg positivity and HBV DNA ≥2000 IU/ml, excluding drug or other causes of hepatitis), hepatitis C (must meet...
- Uncontrolled stable systemic diseases, such as cardiovascular and cerebrovascular diseases, diabetes, etc
- History of organ transplantation or stem cell transplantation
- Heart failure (patients classified as NYHA Class III-IV according to the New York Heart Association)
- Significant pulmonary disease (such as shortness of breath at rest or with mild activity or requiring oxygen for any reason)
- Other underlying diseases judged by the investigator before the study that prevent the use of study medication or interfere with disease diagnosis, or have the potential to cause serious complications
- Concurrent other serious infections before dosing
- Alcohol dependence or a history of drug or substance abuse within the last year
- A history of clear neurological or psychiatric disorders, such as epilepsy, dementia, poor compliance, or the presence of peripheral nervous system disorders
- Pregnancy or breastfeeding, or expected to be pregnant or give birth during the trial period
- Known allergy or intolerance to intravenous mitomycin and corresponding excipients
- Patients whom the investigator deems unsuitable for the trial for other reasons
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
- Xiangyang, Hubei, 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 Wuhan, Hubei, China; Xiangyang, Hubei, 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.