Study of Disitamab Vedotin Plus Bicalutamide for Treating Advanced HER2 and AR-Positive Scrotal Pagets Disease

What this Trial Is About

Researchers are evaluating whether the combination of Disitamab Vedotin and Bicalutamide can treat advanced HER2-positive and androgen receptor AR-positive extramammary Paget disease of the scrotum. This Phase 2 clinical trial also aims to assess the safety of this drug combination in affected male patients. The study is sponsored by Fudan University and involves close monitoring of tumor responses during treatment using imaging techniques based on RECIST criteria. Participants receive Disitamab Vedotin every two weeks and take Bicalutamide daily throughout the treatment period. Follow-up continues until disease progression, intolerable side effects, withdrawal of consent, loss to follow-up, or death. The study measures include the objective response rate every six weeks up to 24 weeks, as well as progression-free survival and adverse events over approximately two years. During the trial, patients undergo clinical tumor imaging assessments and regular evaluations to monitor disease status and safety. Researchers track measurable lesions and skin lesions as per established criteria. The study involves ongoing safety monitoring and collects data on patient outcomes until the studys completion, with total participation lasting up to around two years.

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