Actively Recruiting
A Clinical Trial Aimed at Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder Cancer
Led by The Affiliated Hospital of Xuzhou Medical University · Updated on 2024-10-09
16
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor
X
Xuzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an experimental study to evaluate the efficacy and safety of VT-101 for the treatment of non-muscle invasive bladder cancer
CONDITIONS
Official Title
A Clinical Trial Aimed at Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Confirmed diagnosis of non-muscle-invasive bladder cancer (high-grade Ta, any T1 papillary carcinoma, or carcinoma in situ) from biopsy within 8 weeks before first treatment
- For high-risk disease after second TURBT, all visible tumors must be removed before enrollment
- Negative for high-grade urothelial carcinoma in cellular pathology before enrollment, except for unresectable high-risk patients in dose-escalation phase
- Moderate, high risk, or very high risk NMIBC as defined by clinical criteria including tumor grade and risk factors
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Expected survival of at least 2 years
- Adequate organ and bone marrow function based on laboratory test results
- Negative pregnancy test within 7 days before treatment for women of childbearing age
- Agreement to use medically approved contraception during study and for 6 months after last treatment for participants of reproductive potential
- Male participants agree not to donate sperm during treatment and for 6 months after
- Willingness to comply with study procedures including cystoscopy, urine cytology, urography, and biopsies
- Fully informed and voluntarily consent to participate with good expected compliance
You will not qualify if you...
- Current or past history of muscle-invasive (T2 or higher), locally advanced, or metastatic bladder cancer
- Urothelial carcinoma of upper urinary tract or prostatic urethra within 24 months prior to enrollment
- Bladder perforation confirmed by cystoscopy or imaging
- Prior systemic treatment, radiation, or surgery for bladder cancer within screening period, other than TURBT or biopsy; intravesical perfusion within 8 weeks except single cytotoxic infusion post-TURBT
- Previous treatment with oncolytic virus or similar drugs
- Severe medical conditions including severe heart disease, cerebrovascular disease, uncontrolled diabetes, severe infection, active ulcers, or uncontrolled hypertension
- Expected major surgery during study period
- Active infection or unexplained fever ≥38.5°C at screening or before first dose
- Immune deficiency, positive tests for HIV, syphilis, active hepatitis B or C with specified viral loads
- Recent major surgery, radiotherapy, participation in other clinical trials, or recent anti-tumor therapy within specified time frames
- Toxicity from prior anti-tumor therapy not resolved to specified levels
- Recent use of immunomodulatory drugs within 2 weeks before first dose
- Allergy to adenovirus or study drug components
- History of psychotropic substance, alcohol, or drug abuse
- Other malignancies within last 5 years except certain cured skin or cervical cancers
- Active or history of autoimmune disease except specified stable conditions
- Use of systemic corticosteroids or immunosuppressants within 4 weeks prior to dosing, except specified low-dose steroids
- Pregnancy, lactation, or plans for children during study and 6 months after last dose
- Need for live vaccine within 30 days before first dose or during study
- Other factors deemed by investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
Research Team
H
Hailong Li, M.D/Ph.D
CONTACT
J
Junnian Zheng, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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