RecruitingPhase 2NCT07646145

Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer

Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Medium-high Risk Non-Muscle-Invasive Bladder Cancer: A Phase II Clinical Trial


Sponsor

Shanxi Province Cancer Hospital

Enrollment

30 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the efficacy and safety of intravenous administration of vedacitinib combined with intravesical instillation of mitomycin in treating patients with high-risk NMIBC with HER2 expression. The goal is to provide a new treatment option for NMIBC patients, reduce the risk of tumor recurrence, decrease the proportion of radical bladder surgery, and improve the quality of life of patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Disitamab Vedotin and a drug called Mitomycin C (MMC) for people with non-muscle-invasive bladder cancer (nmibc). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

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

DRUGDisitamab Vedotin

Disitamab Vedotin injection: 2.0 mg/kg, every two weeks, treatment lasts for 8 to 12 cycles

DRUGMitomycin C (MMC)

Mitomycin bladder intravesical instillation: 40mg per dose. Instill immediately after surgery, then once a week thereafter. The induction chemotherapy instillation lasts for 8 times. Subsequently, it is instilled once a month for a total of 10 months for maintenance chemotherapy.


Locations(1)

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

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NCT07646145


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