Actively Recruiting
Study of Disitamab Vedotin Combined With Toripalimab for Advanced HER2-Positive Extramammary Paget Disease of the Scrotum A Prospective Multicenter Clinical Trial Evaluating Efficacy and Safety
Led by Fujian Medical University Union Hospital · Updated on 2025-01-24
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
F
Fujian Medical University Union Hospital
Lead Sponsor
Z
Zhejiang Tumor Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Disitamab Vedotin and Toripalimab to treat advanced HER2-positive extramammary Paget disease of the scrotum. This phase II, multicenter clinical trial aims to determine if this combination can reduce tumor size and delay disease progression, while also assessing its safety and any medical problems participants may experience. Participants must have HER2-positive advanced scrotal extramammary Paget's disease confirmed by histology and imaging. Participants receive intravenous infusions of Disitamab Vedotin at 2mg/kg and Toripalimab at 3mg/kg every 3 weeks. Treatment continues until disease progression, intolerable side effects, withdrawal of consent, loss to follow-up, or death. The study measures the area of the largest lesion on the scrotal skin and assesses tumor response using imaging criteria throughout the treatment period. Participants visit the clinic every 3 weeks for checkups and tests during treatment. Researchers monitor tumor response every 6 weeks up to 24 weeks and evaluate safety and side effects throughout the study. Follow-up continues until disease progression or other reasons for stopping treatment occur. The study includes men aged 18 to 80 years with good physical status and measurable lesions.
CONDITIONS
Official Title
A Study of RC48-ADC Combined With JS001 for Advanced Extramammary Paget Disease of the Scrotum
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Male participants
- Confirmed diagnosis of scrotal extramammary Paget's disease by histology and imaging
- Pathologically confirmed HER2 positive (immunohistochemical test HER2 ≥ 1+)
- ECOG performance status score of 0 to 1
- At least one measurable lesion (non-nodal lesions ≥ 10 mm longest diameter on CT, nodal lesions ≥ 15 mm shortest diameter on CT) or skin lesions evaluable by WHO criteria
- Adequate organ function including specified blood counts, liver and kidney function, and coagulation parameters
- Estimated life expectancy of at least 3 months
- Voluntary informed consent and willingness to comply with study requirements
You will not qualify if you...
- History of immunodeficiency, including HIV or organ transplantation
- Active autoimmune diseases requiring systemic treatment within 2 years before study start, except replacement therapies
- Current systemic glucocorticoid or immunosuppressive therapy exceeding 10 mg/day prednisone equivalent within 2 weeks before starting treatment
- History of active tuberculosis
- Uncontrollable or recurrent ascites, pericardial effusion, or pleural effusion
- Major organ transplantation
- Major surgery, incisional biopsy, or significant injury within 28 days before treatment start
- Chronic non-healing wounds or fractures
- Live attenuated vaccine within 14 days before treatment or planned during study
- Severe hypersensitivity to monoclonal antibodies or study drug ingredients
- Participation in another clinical trial within 4 weeks before study
- History of severe allergies
- Risk of bleeding, coagulation dysfunction, or current thrombolytic therapy
- History of substance abuse or untreated mental disorders
- Other serious illnesses or conditions that may endanger safety or study completion, as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
Y
Yiming Su, Doctor
R
Ru Chen, Doctor
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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