Extramammary Paget's Disease
Conditions
Interventions
Test group:Use of disitamab vedotin injection
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1: Voluntarily participate in the clinical study; fully understand the study and sign an informed consent form; be willing to follow and be capable of completing all trial procedures. 2: Aged 18-80 years old. 3: Patients with primary extramammary Paget's disease (EMPD) confirmed by our histopathology department; patients with locally advanced or metastatic extramammary Paget's disease that The patient is not amenable to radical resection (TxN+M0-1) and has evaluable lesions (refer to RECIST 1.1 for evaluation criteria). 4: The tumour specimen has been immunohistochemically stained and shows HER2 2+/3+ (based on the Chinese Expert Consensus on the Clinical Pathology of Human Epidermal Growth Factor Receptor 2 Detection in Urothelial Carcinoma). 5: ECOG physical status score: 0 or 1; 6: Expected survival time greater than six months; 7: Organ function and haematopoietic function must meet the following requirements: The white blood cell count (WBC) must be at least 3 x 10^9/L, the absolute neutrophil count (ANC) at least 1.5 x 10^9/L, the platelet count (PLT) at least 80 x 10^9/L, the total bilirubin (TBIL) at most 1.5 x the upper limit of normal (ULN), and the aspartate aminotransferase (AST) at most 2.5 x the ULN. Furthermore, alanine aminotransferase (ALT) levels must be = 50 mL/min. Additionally, international normalised ratio (INR) or plasma prothrombin time (PT) levels must be <= 1.5 × ULN. 8: Female subjects of childbearing potential must agree to use effective contraception throughout the study period and for six months after the last dose of disitamab vedotin. It is the responsibility of all female subjects of childbearing potential to use effective contraception throughout the study period and for a period of six months following the last dose of disitamab vedotin. This includes a negative blood pregnancy test within seven days prior to trial screening. Furthermore, all male and female patients of childbearing potential must agree to use an effective method of contraception throughout the duration of the trial and for a period of six months following its completion. The investigator may define a patient's fertility as the biological capacity to have children and to engage in a normal sexual life.
Exclusion criteria
Exclusion criteria: 1: The patient has a documented history of medical conditions consistent with secondary EMPD (other types of adenocarcinoma). 2: The patient has previously undergone treatment with drugs targeting HER2 for EMPD. 3: Patients who are participating in clinical studies involving other unlisted drugs. 4: Subjects with a documented history of hypersensitivity to large protein agents/monoclonal antibodies, or known hypersensitivity to any of the components of the test drug. 5: Women who are pregnant or breastfeeding are excluded from the study. 6: Those with serious medical conditions, including severe infections, uncontrolled diabetes mellitus, cardiovascular disease (defined as Class III or IV heart failure as per the New York Heart Association classification, heart block of degree II or greater, myocardial infarction, unstable arrhythmia), or pulmonary disease (interstitial pneumonitis, obstructive lung disease, and history of bronchospasm) are excluded from participation. or unstable angina pectoris in the past six months, cerebral infarction in the last three months, etc.), or pulmonary disease (interstitial pneumonitis, obstructive lung disease, and history of bronchospasm). 7: Those with a previous history of definite neurological or psychiatric disorders, such as epilepsy, dementia, and poor compliance, are excluded from participation. 8: A history of drug or substance abuse. 9: A history of other malignancies (history of other malignancies present within 5 years, except for those cases of cured carcinoma in situ and basal cell carcinoma and thyroid cancer). 10: Other severe, acute, or chronic medical conditions or abnormal laboratory tests that may increase the risk of participation in the study and study medication, or that may interfere with the interpretation of study results. 11: Individuals who, in the opinion of the investigator, are otherwise unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival;Adverse events; | — |
Countries
China
Contacts
Public ContactKai Yao
Department of Urology, Sun Yat-sen University Cancer Center
Outcome results
None listed