Actively Recruiting
A Prospective, Single-Arm Clinical Study of Disitamab Vedotin Combined With Bicalutamide in HER2 and AR-Expressing Scrotal Paget's Disease
Led by Fudan University · Updated on 2025-08-12
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
F
Fujian Province Tumor Hospital
Collaborating Sponsor
AI-Summary
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 study's completion, with total participation lasting up to around two years.
CONDITIONS
Brief Title
A Study of Disitamab Vedotin + Bicalutamide in HER2/AR-Positive Scrotal Paget's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and comply with the protocol requirements
- Be 18 years old or older
- Confirmed diagnosis of HER2-positive and AR-positive mammary or extramammary Paget's disease by histological and/or cytological examination with imaging or ultrasound
- ECOG performance status score of 0 to 1
- Have at least one measurable lesion or evaluable skin lesion per RECIST or WHO criteria
- Adequate organ function based on blood, liver, kidney, and coagulation tests
- Estimated life expectancy of at least 3 months
You will not qualify if you...
- History of immunodeficiency, including HIV or organ transplantation
- Active autoimmune diseases requiring systemic treatment within 2 years, or current systemic glucocorticoid or immunosuppressive therapy
- Use of prednisone over 10 mg/day or equivalent within 2 weeks prior to study
- History of active tuberculosis
- Uncontrollable recurrent drainage of ascites, pericardial or pleural effusion
- Major organ transplantation history
- Major surgery, biopsy, or significant injury within 28 days before study
- Chronic non-healing wounds or fractures
- Live attenuated vaccine within 14 days before study or planned during study
- Severe hypersensitivity to monoclonal antibodies or ingredients of the study drug
- Participation in other clinical studies within 4 weeks prior to study
- History of severe allergies
- Risk of bleeding, coagulation dysfunction, or receiving thrombolytic therapy
- History of substance abuse or mental disorders
- Other serious diseases or conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive Disitamab Vedotin combined with Bicalutamide to treat HER2 and AR-expressing Scrotal Paget's Disease.
Visits every 6 weeks during treatment
Duration - Up to 2 years
Participants are monitored for progression free survival and adverse events after treatment completion.
Visits scheduled through study completion over an average of 2 years
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200230
Actively Recruiting
Research Team
H
Hengchuan Su
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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