Non-Muscle-Invasive Bladder Cancer (NMIBC)Phase 3NCT06696794
Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients
A Phase 3 study testing Mitomycin C (MMC) in people with Non-Muscle-Invasive Bladder Cancer (NMIBC), run by Shaogang Wang at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Muscle-Invasive Bladder Cancer (NMIBC)
- What is being tested?
- Mitomycin C (MMC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 3 sitesChina
- Study dates
- 17 Feb 2025to 30 Jun 2031
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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; Ta HG/G3 or T1 LG, non-CIS with at least two risk factors; T1G2 non-CIS with at least one risk factor. (Risk factors: age > 70 years; multiple papillary tumors; tumor diameter > 3cm)
- Participants are willing to provide the last cystoscopy biopsy specimen or specimens from the previous recurrence surgery (including paraffin blocks, paraffin-embedded sections, etc.)
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- 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 the upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; Serum total bilirubin ≤ 1.5 times ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN (except for patients on anticoagulant therapy)
- 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 age must have a negative blood pregnancy test within 72 hours before the first new adjuvant instillation, and must agree to use effective contraceptive measures during the treatment period and for at least 180 days after en-bloc treatment
Who cannot join
- 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 low-risk prostate cancer (staging ≤T2b, Gleason score ≤7, and PSA ≤ 20ng/ml, with no recurrence after treatment as determined by follow-up PSA levels); ② Patients with low-risk prostate cancer (staging T1/T2a, Gleason score ≤7, and PSA ≤10ng/ml, in the observation phase without treatment; ③ Patients who meet other enrollment criteria but have very low risk of metastasis or death from malignant tumors, and who show no recurrence or metastasis after standard treatment, as confirmed by imaging and disease-specific tumor marker tests, such as fully treated carcinoma in situ of the cervix, basal or squamous cell skin cancer; in situ ductal carcinoma after treatment surgery, etc
- 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, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is excluded
- 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 previous anti-cancer treatments (immune-related toxicity excluded) has not recovered to ≤Grade 2, except for alopecia
- Patients who are seropositive for Human Immunodeficiency Virus (HIV) or have a history of HIV infection or other acquired immunodeficiency diseases
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- 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 both anti-HCV antibody positivity and HCV-RNA results greater than the lower limit of detection)
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
The central Hospital of wuhan
Wuhan, Hubei, 430000
Yonglian Guo, +86-027-82211521, Guoyonglian662299@aliyun.com
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Yang Xun, 027-83663460, tjxyang1993@163.com
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei
Bin Chen, +86 2812096, 625848080@qq.com
About this study
Official title: Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C Combined with En-bloc Surgery in Treating High-risk Non-muscle-invasive Bladder Cancer (NMIBC) Patients
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. The main questions it aims to answer are:
Does neoadjuvant intravesical instillation of mitomycin C heighten the 1-year recurrence-free survival (RFS) rate for high-risk non-muscle-invasive bladder cancer (NMIBC) patients? What medical problems do participants have when taking neoadjuvant intravesical instillation of mitomycin C? Researchers will compare neoadjuvant intravesical instillation of mitomycin C to a placebo (normal saline) to see if neoadjuvant intravesical instillation of mitomycin C works to treat high-risk NMIBC.
Read more
Participants will:
Take neoadjuvant intravesical instillation of mitomycin C or a placebo twice，1 day and 4 hours before en-bloc surgery Visit the clinic once every 8 weeks for checkups and tests Keep track of the recurrence and progression of the tumor.
- Being tested
- Mitomycin C (MMC), Normal Saline (Placebo)
- Keywords
- high-risk non-muscle-invasive bladder cancer, neoadjuvant intravesical instillation, mitomycin C, en-bloc surgery
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin C (MMC)Drug
When administering neoadjuvant intravesical instillations, instruct the patient to lie flat on the treatment bed and cover with a waterproof pad. Disinfect the perineal area 2-3 times. Under sterile conditions, insert a catheter and drain the bladder of urine completely. Slowly instill the prepared instillation solution (mitomycin) into the bladder. If the patient experiences pain during the instillation, stop the infusion immediately, and continue when the pain subsides. If the patient still cannot tolerate it, discontinue the instillation treatment for this session. After the medication is instilled into the bladder, the catheter can be removed immediately or left in place. Instruct the patient to hold their urine for as long as possible under suitable conditions for 2 hours, and to change positions intermittently while the medication is retained in the bladder. The neoadjuvant intravesical instillation cycle is twice (one day and 4 h before en-bloc surgery）
Normal Saline (Placebo)Drug
When administering neoadjuvant intravesical instillations, instruct the patient to lie flat on the treatment bed and cover with a waterproof pad. Disinfect the perineal area 2-3 times. Under sterile conditions, insert a catheter and drain the bladder of urine completely. Slowly instill the prepared instillation solution (Normal Saline) into the bladder. If the patient experiences pain during the instillation, stop the infusion immediately, and continue when the pain subsides. If the patient still cannot tolerate it, discontinue the instillation treatment for this session. After the medication is instilled into the bladder, the catheter can be removed immediately or left in place. Instruct the patient to hold their urine for as long as possible under suitable conditions for 2 hours, and to change positions intermittently while the medication is retained in the bladder. The neoadjuvant intravesical instillation cycle is twice (one day and 4 h before en-bloc surgery）
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant intravesical instillation mitomycin C combined with en-bloc surgery | Experimental | Not described Receives: Drug: Mitomycin C (MMC) |
| Neoadjuvant intravesical instillation normal saline combined with en-bloc surgery | Placebo comparator | Not described Receives: Drug: Normal Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year recurrence-free survival rate
The one-year recurrence-free survival rate, as assessed by researchers, is defined as the proportion of patients who are free of tumor recurrence at one year after randomization. Recurrence is defined as any pathological level of urothelial carcinoma confirmed by cystoscopy and biopsy during the one-year follow-up period starting from the time of randomization.
Measured: One year after randomization
Secondary outcomes (4)
Progression free survival
This was determined by cystoscopy and pathology every eight weeks for one year and telephone follow-up every one year after one year until tumor progression and patient death from any cause, or five years after the end of the study. Defined as the time between the start of randomization and progression of disease or death from any cause, whichever occurs first. Disease progression was defined as an increase in bladder tumors from Ta/T1 to T1/ T2 or larger, lymph node metastasis and distant metastasis, or an increase in tumor grade from low to high.
Measured: Every eight weeks for one year and telephone follow-up every one year after one year until tumor progression and patient death from any cause, or five years after the end of the study.
overall survival
Telephone follow-up was conducted every 1 year after the start of randomization until death from any cause or 5 years after the end of the study.
Measured: up to 5 years after the end of the study.
Health-related quality of life
The health-related quality of life of the patients was assessed by EORTC QLQ-C30
Measured: up to One year after discharge
Adverse event
Adverse events were coded using the International Dictionary of Medical Terms (MedDRA), and adverse events (TEAE) during treatment were aggregated by Systematic Organ Classification (SOC), Preferred term (PT), and NCI-CTCAE grading. The number, frequency and incidence of adverse events and drug-related adverse events of all subjects were counted. Make a list of adverse events. This is determined by interview, physical examination, as well as the patient's vital signs and laboratory tests.
Measured: up to Eight weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start17 Feb 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle-Invasive Bladder Cancer (NMIBC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a double-blind, parallel-group, placebo-controlled, multicenter, prospective, randomized controlled Phase III clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaogang Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shaogang Wang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696794
- Sponsor's protocol ID
- 2024TJCR012
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C Combined with En-bloc Surgery in Treating High-risk Non-muscle-invasive Bladder Cancer (NMIBC) Patients
- ClinicalTrials.gov ID
- NCT06696794
- Acronym / sponsor ID
- 2024TJCR012
- Keywords
- high-risk non-muscle-invasive bladder cancer, neoadjuvant intravesical instillation, mitomycin C, en-bloc surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shaogang WangUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The main questions it aims to answer are:
Does neoadjuvant intravesical instillation of mitomycin C heighten the 1-year recurrence-free survival (RFS) rate for high-risk non-muscle-invasive bladder cancer (NMIBC) patients? What medical problems do participants have when taking neoadjuvant intravesical instillation of mitomycin C? Researchers will compare neoadjuvant intravesical instillation of mitomycin C to a placebo (normal saline) to see if neoadjuvant intravesical instillation of mitomycin C works to treat high-risk NMIBC.
Participants will:
Take neoadjuvant intravesical instillation of mitomycin C or a placebo twice，1 day and 4 hours before en-bloc surgery Visit the clinic once every 8 weeks for checkups and tests Keep track of the recurrence and progression of the tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This was a double-blind, parallel-group, placebo-controlled, multicenter, prospective, randomized controlled Phase III clinical trial
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant intravesical instillation mitomycin C combined with en-bloc surgery | Experimental | Drug: Mitomycin C (MMC) |
| Neoadjuvant intravesical instillation normal saline combined with en-bloc surgery | Placebo comparator | Drug: Normal Saline (Placebo) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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; Ta HG/G3 or T1 LG, non-CIS with at least two risk factors; T1G2 non-CIS with at least one risk factor. (Risk factors: age > 70 years; multiple papillary tumors; tumor diameter > 3cm)
Key exclusion criteria (18 listed)
- 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 low-risk prostate cancer (staging ≤T2b, Gleason score ≤7, and PSA ≤ 20ng/ml, with no recurrence after treatment as determined by follow-up PSA levels); ② Patients with low-risk prostate cancer (staging T1/T2a, Gleason score ≤7, and PSA ≤10ng/ml, in the observation phase without treatment; ③ Patients who meet other enrollment criteria but have very low risk of metastasis or death from malignant tumors, and who show no recurrence or metastasis after standard treatment, as confirmed by imaging and disease-specific tumor marker tests, such as fully treated carcinoma in situ of the cervix, basal or squamous cell skin cancer; in situ ductal carcinoma after treatment surgery, etc
- 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, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is excluded
- 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 previous anti-cancer treatments (immune-related toxicity excluded) has not recovered to ≤Grade 2, except for alopecia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitomycin C (MMC)When administering neoadjuvant intravesical instillations, instruct the patient to lie flat on the treatment bed and cover with a waterproof pad. Disinfect the perineal area 2-3 times. Under sterile conditions, insert a catheter and drain the bladder of urine completely. Slowly instill the prepared instillation solution (mitomycin) into the bladder. If the patient experiences pain during the instillation, stop the infusion immediately, and continue when the pain subsides. If the patient still cannot tolerate it, discontinue the instillation treatment for this session. After the medication is instilled into the bladder, the catheter can be removed immediately or left in place. Instruct the patient to hold their urine for as long as possible under suitable conditions for 2 hours, and to change positions intermittently while the medication is retained in the bladder. The neoadjuvant intravesical instillation cycle is twice (one day and 4 h before en-bloc surgery） | Drug | Neoadjuvant intravesical instillation mitomycin C combined with en-bloc surgery |
| Normal Saline (Placebo)When administering neoadjuvant intravesical instillations, instruct the patient to lie flat on the treatment bed and cover with a waterproof pad. Disinfect the perineal area 2-3 times. Under sterile conditions, insert a catheter and drain the bladder of urine completely. Slowly instill the prepared instillation solution (Normal Saline) into the bladder. If the patient experiences pain during the instillation, stop the infusion immediately, and continue when the pain subsides. If the patient still cannot tolerate it, discontinue the instillation treatment for this session. After the medication is instilled into the bladder, the catheter can be removed immediately or left in place. Instruct the patient to hold their urine for as long as possible under suitable conditions for 2 hours, and to change positions intermittently while the medication is retained in the bladder. The neoadjuvant intravesical instillation cycle is twice (one day and 4 h before en-bloc surgery） | Drug | Neoadjuvant intravesical instillation normal saline combined with en-bloc surgery |
Primary outcome
1-year recurrence-free survival rate
Time frame: One year after randomization
The one-year recurrence-free survival rate, as assessed by researchers, is defined as the proportion of patients who are free of tumor recurrence at one year after randomization. Recurrence is defined as any pathological level of urothelial carcinoma confirmed by cystoscopy and biopsy during the one-year follow-up period starting from the time of randomization.
4 secondary outcomes
Progression free survival
Time frame: Every eight weeks for one year and telephone follow-up every one year after one year until tumor progression and patient death from any cause, or five years after the end of the study.
overall survival
Time frame: up to 5 years after the end of the study.
Health-related quality of life
Time frame: up to One year after discharge
Adverse event
Time frame: up to Eight weeks after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mitomycin C (MMC) in people with Non-Muscle-Invasive Bladder Cancer (NMIBC), run by Shaogang Wang at 3 sites 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 9 inclusion and 18 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 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yang Xun, Doctor of Medicine (+86-27-83663460, tjxyang1993@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year recurrence-free survival rate (time frame: One year after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2025.