Actively Recruiting
A Study of Disitamab Vedotin + Bicalutamide in HER2/AR-Positive Scrotal Paget's Disease
Led by Fudan University · Updated on 2025-08-12
20
Participants Needed
1
Research Sites
125 weeks
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
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.
CONDITIONS
Official 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
- Age 18 years or older
- Confirmed diagnosis of mammary or extramammary Paget's disease by histological or cytological examination combined with imaging or ultrasound
- Pathologically confirmed HER2 positive (immunohistochemical test HER2 61 1+)
- Pathologically confirmed AR positive (immunohistochemical test AR 61 1+)
- ECOG performance status score of 0 to 1
- At least one measurable lesion according to RECIST criteria: non-nodal lesions with a longest diameter 61 10 mm on CT scan, nodal lesions with a shortest diameter 61 15 mm on CT scan, or evaluable skin lesions by WHO criteria
- Adequate organ function including blood counts, liver and renal function, and coagulation parameters within specified limits
- Estimated life expectancy of at least 3 months
You will not qualify if you...
- History of immunodeficiency including HIV or other acquired or congenital immunodeficiency diseases, or organ transplantation
- Active autoimmune diseases requiring systemic treatment within 2 years prior to study start
- Current systemic glucocorticoid or immunosuppressive therapy exceeding 10 mg/day prednisone equivalent within 2 weeks of study start
- History of active tuberculosis
- Uncontrollable, recurrent drainage of ascites, pericardial effusion, or pleural effusion
- Major organ transplantation
- Major surgery, incisional biopsy, or significant traumatic injury within 28 days prior to study start
- Chronic non-healing wounds or fractures
- Recent live attenuated vaccine administration within 14 days prior to study start or planned during study
- Severe hypersensitivity to monoclonal antibodies or study drug ingredients
- Participation in other clinical studies within 4 weeks prior to study start
- History of severe allergies
- Risk of bleeding, coagulation dysfunction, or current thrombolytic therapy
- History of substance abuse or mental disorders preventing study compliance
- Other serious concomitant diseases or conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200230
Actively Recruiting
Research Team
H
Hengchuan Su
CONTACT
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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