scrotal Extramammary Paget's disease
Conditions
Interventions
study group:RC48-ADC (disitamab vedotin) combined with toripalimab
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1). Voluntarily participate in the experiment and sign a written informed consent form; 2). The patient is aged>=18 years and = 2 years; 3). Diagnosed with scrotal Paget's disease through histopathological examination, with stages IIIb and IV of scrotal Paget's disease; 4). The central laboratory defined HER2 expression as HER2 immunohistochemistry staining 1+, 2+, or 3+in the biopsy tissue of scrotal skin lesions. HER2[4B5, Roche Diagnostic Products (Shanghai) Co., Ltd.], immunohistochemistry was performed using Roche Ventana automatic staining instrument. Refer to the operation guide for the operation process. HER2 positive signal is localized to the cell membrane. Reference for immunohistochemical evaluation criteria. 5). Participants must not have received systemic treatment for locally advanced or metastatic scrotal Paget's disease before; 6). Eastern Cooperative Oncology Group (ECOG) score: 0-2 points; 7). Complete screening of relevant examinations (blood routine, liver and kidney function, thyroid function, adrenal cortex function, 12 lead electrocardiogram, lung CT plain scan, abdominal enhanced CT or MR, histopathological examination, and HER2 immunohistochemical staining), with normal heart, lung, bone marrow, liver, kidney, and coagulation functions, and no contraindications for the use of vediximab and terimumab.
Exclusion criteria
Exclusion criteria: 1). Any of the following situations: People with immune deficiency or damage (such as AIDS patients), who are using immunosuppressive drugs or radiotherapy, and who may cause a systemic disease response to teriprizumab; Individuals who are allergic to the components of vediximab or triprolizumab; Patients with fever and acute infectious diseases, including active tuberculosis, or those receiving anti tuberculosis treatment; Accompanied by severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease; 2). Merge with other tumors of the urinary and reproductive system or other organs; 3). Widespread systemic metastasis, generally poor condition, and inability to tolerate treatment in patients; 4). Individuals who have received chemotherapy, radiation therapy, or immunotherapy within the past 3 months; 5). Patients with various mental disorders, severe coagulation function, heart, lung, liver and kidney function, hematopoietic dysfunction, etc. who cannot tolerate drug treatment; 6). Participated in clinical trials of other drugs within the first 3 months of enrollment; 7). Known opioid or alcohol dependent individuals; 8). Researchers believe that there may be any situation that increases the risk to participants or interferes with the execution of clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area of the largest lesion on the scrotal skin;The longest diameter of metastatic lymph nodes ;The longest diameter of visceral metastatic lesions;blood routine;liver function and renal function;Thyroid Function;Corticosteroid (8:00);ACTH;Objective response rate; | — |
Countries
China
Contacts
Public ContactShaoxing, Zhu
Fujian Medical University Union Hospital
Outcome results
None listed