Gynecological tumors
Conditions
Interventions
DisitamabVedotin plus Sindillimab: DisitamabVedotin :2.0mg/kg, D1, iv, 14 days as a treatment cycle
Sindilizumab 200mg, D1, iv, 21 days for one treatment cycle
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Female patients who are over or equal to 18 years old at the time of signing the informed consent form; 2. Recurrent EC confirmed by pathological histology, progressing with first-line standard treatment; 3. The immunohistochemical (IHC) test results of archived tissue (within 6 months) or fresh biopsy lesions show HER2 expression: IHC 1+ 2+or 3+; 4 ECOG PS: 0-1 points; 5. Expected survival period>12 weeks; 6. Adequate organ function: - Bone marrow function: hemoglobin>=9g/dL; Absolute neutrophil count>=1.5 × 10 9/L; White blood cell count>=3.0 × 10 ^ 9/L; Platelets>=100 × 10 ^ 9/L; - Liver function: serum total bilirubin=60 mL/min; - Cardiac function: NYHA classification=50%; 7. At least one measurable lesion defined in RECIST version 1.1; 8. Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with negative results, and be willing to use appropriate contraception methods during the trial period and 8 weeks after the last administration of the trial drug. 9. The subjects voluntarily joined this study and signed an informed consent form, with good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Received systemic treatment containing paclitaxel within 6 months 2. Previously received ADC drugs, immunotherapy drugs, anti-HER2 therapy, and other treatments; 3. Having active autoimmune diseases and receiving systemic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years, including but not limited to uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (clinically asymptomatic hypothyroidism or hypothyroidism caused by radiotherapy and chemotherapy can be included); 4. Subjects with a history of other malignant tumors within the past five years (excluding complete treatment for in situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma skin cancer); 5. Serious cardiovascular and cerebrovascular diseases or discomfort, including but not limited to the following diseases: --Diagnosed history of heart failure or systolic dysfunction (LVEF180 mmHg and/or diastolic blood pressure>100 mmHg) 6. Individuals with a known history of allergies to the components of this medication regimen; 7. History of immunodeficiency, including HIV positive test results, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 8. Within 4 weeks before starting treatment, symptomatic brain metastases or brain metastases treatment (excluding prophylactic cranial radiation); 9. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or reproductive age patients who are unwilling to take effective contraceptive measures throughout the trial period; 10. Suffering from serious accompanying diseases or other comorbidities that may interfere with planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate in this study.symptoms or due to chemoradiotherapy can be included); 4) Subjects with a history of other malignancies within five years (except for complete treatment of cervical or basal cell carcinoma in situ or squamous cell carcinoma skin cancer); 5) Serious cardiovascular and cerebrovascular disease or discomfort, including but not limited to the following diseases: History of heart failure or systolic dysfunction (LVEF 180 mmHg and/or diastolic > 100 mmHg) 6) Known allergic history of the drug components of this protocol; 7) A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 8) symptomatic brain metastases or brain metastases (excluding prophylactic cranial irradiation) within 4 weeks prior to initiation of treatment; 9) Pregnant and lactating women, fertile women who tested positive for baseline pregnancy tests, or patients of childbearing age who were unwilling to take effective contraception throughout the trial period; 10) Have a serious concomitant condition or other comorbid condition that interferes with planned treatment, or any other condition in which the investigator deems the patient unsuitable for participation i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Disease control rate;Duration of Response;Safety; | — |
Countries
China
Contacts
Public ContactFang Ren
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed