A Study of Disitamab Vedotin + Bicalutamide in HER2/AR-Positive Scrotal Paget's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorFudan University
About this trial
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.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent form and comply with the requirements of the protocol.
Age ≥ 18 years old.
Confirmed diagnosis by histological examination and/or cytological examination, combined with imaging or ultrasound assessment for mammary and extramammary Paget's disease; pathologically confirmed as HER2 positive, i.e., immunohistochemical test HER2 ≥ 1+, and AR positive, i.e., immunohistochemical test AR ≥ 1+.
ECOG score: 0 to 1.
Disqualifiers
Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
Have had active autoimmune diseases within 2 years prior to the start of the study treatment that required systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants), except for replacement therapies (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency); currently receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy.
The dose is >10mg/day of prednisone or other equivalent hormones, and it is within 2 weeks of the first administration and still in use;
Have a history of active tuberculosis;
Trial design
Treatments tested in this trial
- Disitamab Vedotin combined with Bicalutamide
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Fudan University
Lead sponsor
Fujian Province Tumor Hospital
Collaborator
Qinghai Province Fifth People's Hospital
Collaborator
Source ClinicalTrials.gov