Actively Recruiting
A Prospective Multicenter Clinical Trial on the Efficacy and Safety of RC48-ADC (Disitamab Vedotin) Combined With Toripalimab in Advanced HER2-positive Extramammary Paget Disease of the Scrotum
Led by Fujian Medical University Union Hospital · Updated on 2025-01-24
20
Participants Needed
1
Research Sites
52 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 clinical trial aims to determine if this combination reduces tumor size and delays disease progression, while also studying the safety and medical problems that may occur during treatment. Participants will receive intravenous infusions of Disitamab Vedotin at 2mg/kg and Toripalimab at 3mg/kg every 3 weeks. Treatment continues until the disease progresses, intolerable side effects occur, or other specified reasons arise. The study includes regular clinical tumor imaging and lesion measurements during treatment. Participants visit the clinic every 3 weeks for checkups and tests, including assessments of tumor response using RECIST criteria. The main outcome measured is the objective response rate every 6 weeks for up to 24 weeks. Secondary outcomes include progression-free survival and adverse events monitored over an average of 2 years. Follow-up continues until disease progression, withdrawal, loss to follow-up, or death.
CONDITIONS
Brief 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...
- Voluntarily sign the informed consent form and comply with the protocol requirements
- Age 18 years or older
- Confirmed diagnosis of scrotal extramammary Paget's disease with HER2 positive status
- ECOG performance status score of 0 to 1
- At least one measurable lesion on CT scan or skin lesion evaluable by WHO criteria
- Adequate organ function based on blood counts, 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 prior to study
- Current systemic glucocorticoid or immunosuppressive therapy above specified doses
- History of active tuberculosis
- Uncontrollable or recurrent fluid drainage such as ascites or pleural effusion
- Major organ transplantation or major surgery within 28 days prior to study
- Chronic non-healing wounds or fractures
- Recent live attenuated vaccine administration or planned vaccination during the study
- Severe hypersensitivity to monoclonal antibodies or study drug components
- Participation in other clinical trials within 4 weeks prior to study
- History of severe allergies
- Risk of bleeding, coagulation dysfunction, or current thrombolytic therapy
- History of substance abuse or mental disorders affecting compliance
- Other serious diseases or conditions judged 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.
screening and enrollment visit
Duration - Until disease progression or discontinuation
Participants receive Disitamab Vedotin combined with Toripalimab intravenous infusion every 3 weeks until disease progression, intolerable adverse reactions, withdrawal, loss to follow-up, or death.
Infusions every 3 weeks
Duration - Up to 2 years
Participants are monitored for safety and disease progression after treatment ends.
Visits every 6 weeks during follow-up
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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