Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07646145
PHASE2

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

Sponsor: Shanxi Province Cancer Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-04-01

Completion Date

2027-04

Last Updated

2026-06-12

Healthy Volunteers

No

Interventions

DRUG

Disitamab Vedotin

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

DRUG

Mitomycin 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