Actively Recruiting
A Study of RC48-ADC Combined With JS001 for Advanced Extramammary Paget Disease of the Scrotum
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
The goal of this clinical trial is to learn if Disitamab Vedotin combined with Toripalimab works to treat advanced HER2-positive extramammary Paget disease of the scrotum. It will also learn about the safety of this combination. The main questions it aims to answer are: Does this combination reduce tumor volume and delay disease progression? What medical problems do participants have when receving this combination? Participants will: Intravenous using this combination every 3 weeks until disease progression or intolerable adverse reactions occur. Visit the clinic once every 3 weeks for checkups and tests.
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
AI-Powered 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
CONTACT
R
Ru Chen, Doctor
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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