A Study on the Efficacy of Disitamab Vedotin in Advanced HER2-positive Paget's Disease.
- Conditions
- Mammary or Extramammary Paget's Disease
- Registration Number
- NCT06561555
- Lead Sponsor
- Fudan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Voluntarily sign the informed consent form and comply with the requirements of the<br> protocol.<br><br> - Age = 18 years old.<br><br> - Confirmed diagnosis by histological examination and/or cytological examination,<br> combined with imaging or ultrasound assessment for mammary and extramammary Paget's<br> disease; pathologically confirmed as HER2 positive, i.e., immunohistochemical test<br> HER2 = 1+.<br><br> - ECOG score: 0 to 1.<br><br> - At least one measurable lesion (according to the RECIST criteria, non-nodal lesions<br> with a longest diameter on CT scan =10 mm, and nodal lesions with a shortest<br> diameter on CT scan =15 mm); or skin lesions that can be evaluated according to the<br> WHO criteria.<br><br> - Adequate organ function: Blood routine: Absolute Neutrophil Count (ANC) =1.5×10^9/L,<br> Platelet (PLT) =70×10^9/L, Hemoglobin (HGB) =80g/L; Liver function: Total Bilirubin<br> (TBIL) =1.5×Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and<br> Aspartate Aminotransferase (AST) =3×ULN; Serum Albumin =28 g/L; Alkaline Phosphatase<br> (ALP) =5×ULN; If the subject has received routine liver protection treatment and<br> meets the above standards, and is stable for at least one week after assessment by<br> the researcher, they may be enrolled; Renal function: Serum Creatinine (Cr)<br> =1.5×ULN, or Creatinine Clearance =50 mL/min (using the standard Cockcroft-Gault<br> formula): Coagulation function: International Normalized Ratio (INR) =1.5 /<br> Prothrombin Time (PT) =1.5×ULN, Activated Partial Thromboplastin Time (aPTT)<br> =1.5×ULN; If the subject is receiving anticoagulant therapy, as long as PT and INR<br> are within the range specified for the anticoagulant medication, it is acceptable.<br><br> - Estimated life expectancy =3 months.<br><br>Exclusion Criteria:<br><br> - Have a history of immunodeficiency, including HIV positive or other acquired or<br> congenital immunodeficiency diseases, or a history of organ transplantation;<br><br> - Have had active autoimmune diseases within 2 years prior to the start of the study<br> treatment that required systemic treatment (such as the use of disease-modifying<br> drugs, corticosteroids, or immunosuppressants), except for replacement therapies<br> (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or<br> pituitary insufficiency); currently receiving systemic glucocorticoid therapy or any<br> other form of immunosuppressive therapy. The dose is >10mg/day of prednisone or<br> other equivalent hormones, and it is within 2 weeks of the first administration and<br> still in use;<br><br> - Have a history of active tuberculosis;<br><br> - Have uncontrollable, recurrent drainage of ascites, pericardial effusion, or pleural<br> effusion;<br><br> - Have undergone major organ transplantation;<br><br> - Received major surgical treatment, incisional biopsy, or significant traumatic<br> injury within 28 days prior to the start of the study treatment; or have chronic<br> non-healing wounds or fractures;<br><br> - Have a history of live attenuated vaccine administration within 14 days prior to the<br> start of the study treatment or plan to receive live attenuated vaccine vaccination<br> during the study period;<br><br> - Have had a severe hypersensitivity reaction after the use of monoclonal antibodies;<br> known allergy to the active ingredients or excipients of this study drug;<br><br> - Within 4 weeks prior to the start of the study, are participating in or have<br> participated in other clinical studies;<br><br> - Have a history of severe allergies;<br><br> - Have a risk of bleeding, or coagulation dysfunction, or are currently receiving<br> -thrombolytic therapy;<br><br> - Have a history of substance abuse and are unable to quit or have mental disorders;<br><br> - According to the investigator's judgment, there are concomitant diseases that<br> seriously endanger the safety of the subject or affect the completion of the study,<br> or there are other reasons deemed unsuitable for enrollment by the investigator.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response Rate
- Secondary Outcome Measures
Name Time Method Progression free survival;advance events