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RECRUITING
NCT07117851
PHASE2

A Study of Disitamab Vedotin + Bicalutamide in HER2/AR-Positive Scrotal Paget's Disease

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if Disitamab Vedotin combined with Bicalutamide works to treat advanced HER2-positive and AR- positive extramammary Paget disease of the scrotum. It will also learn about the safety of this combination. All patients received Disitamab Vedotin every 2 weeks and Bicalutamide everyday. Follow-up was conducted until disease progression, intolerable adverse reactions occur withdrawal of informed consent by the subject, loss to follow-up, or death. Clinical tumor imaging assessments were performed using RECIST during the treatment process.

Official title: A Prospective, Single-Arm Clinical Study of Disitamab Vedotin Combined With Bicalutamide in HER2 and AR-Expressing Scrotal Paget's Disease

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-08-01

Completion Date

2027-12-30

Last Updated

2025-08-12

Healthy Volunteers

No

Interventions

DRUG

Disitamab Vedotin combined with Bicalutamide

Single Group Assignment

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China