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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Disitamab Vedotin combined with Bicalutamide
DrugSingle Group Assignment
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Drug: Disitamab Vedotin combined with BicalutamideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate
ORR includes two categories: Complete Response (CR): All target lesions in the patient have completely disappeared, and no new lesions have appeared for a certain time. Partial Response (PR): The tumor in the patient has reduced in size by at least 30%, and this reduction has been maintained for a certain period.
Time frame
every 6 weeks,up to 24 weeksSecondary outcomes
1
Progression free survival
Progression-Free Survival (PFS) is a clinical endpoint used primarily in oncology to measure the effectiveness of a treatment in delaying the progression of a disease. It is defined as the length of time during which a patient's disease does not get worse after starting a treatment. PFS takes into account the time from the start of treatment until the first occurrence of disease progression, or the patient's death if it occurs before progression.
Time frame
through study completion, an average of 2 year2
advance events
advance events
Time frame
through study completion, an average of 2 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fudan University
Lead sponsor
Fujian Province Tumor Hospital
Collaborator
Qinghai Province Fifth People's Hospital
Collaborator
Source ClinicalTrials.gov