RecruitingPhase 1NCT06632964

A Clinical Trial Aimed at Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder Cancer

An Open-label, Single-arm Exploratory Clinical Trial Aimed at Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder Cancer


Sponsor

The Affiliated Hospital of Xuzhou Medical University

Enrollment

16 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an experimental study to evaluate the efficacy and safety of VT-101 for the treatment of non-muscle invasive bladder cancer


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called VT-101 for treating non-muscle-invasive bladder cancer (NMIBC) — a type of bladder cancer that has not spread into the deeper muscle layers of the bladder. The drug is administered directly into the bladder. The study is examining both its safety and effectiveness for people with moderate to very high risk NMIBC, including those who have not responded to BCG immunotherapy. **You may be eligible if...** - You are 18–75 years old with confirmed non-muscle-invasive bladder cancer - Your cancer is moderate, high, or very high risk - You have good overall physical status (ECOG 0–1) and expected survival of at least 2 years - Your blood counts, liver, and kidney function meet minimum levels - You are willing to undergo regular cystoscopy and other monitoring procedures **You may NOT be eligible if...** - Your bladder cancer has spread into the muscle or beyond (T2 or higher) - You have had bladder cancer surgery, radiation, or systemic treatment recently (excluding standard TURBT) - You have HIV, active hepatitis B or C, or active serious infections - You are pregnant, breastfeeding, or planning to conceive during the trial - You have severe heart conditions, uncontrolled high blood pressure, or a history of psychotropic substance abuse - You have had other cancers within the last 5 years (with limited exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRecombinant oncolytic adenovirus injection solution of VT-101

Active ingredient: VT-101 recombinant oncolytic adenovirus Specifications: 2×10\^10 IFU/ml, 0.5ml/ capsule Method of administration: intravesical perfusion


Locations(1)

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

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NCT06632964


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