cervical cancer?endometrial, and ovarian cancer
Conditions
Interventions
Sponsors
Second People's Hospital of Changzhou City
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Cervical cancer, endometrial cancer and ovarian cancer were diagnosed by histopathology or cytology; 2. Aged 18 to 75 years old; 3. ECOG PS score 0-2; 4. The estimated survival time >=12 weeks or more; 5. Agree to collect tumor histological specimens required for this study and apply them to relevant studies; 6. According to RECIST V1.1, there is at least one measurable lesion; 7. The functions of vital organs and bone marrow meet the following requirements: Blood routine examination: Absolute count of neutrophils (ANC) >=1.5x10^9/L, platelet (PLT) >=80x10^9/L, hemoglobin (HGB) >=9g/dL; Liver function: serum total bilirubin (TBIL) =2.8g /dL; Renal function: serum creatinine (Cr) =40 mL/min (using standard Cockcroft -- Gault formula): Female: CrCl= (140- age) x weight (kg) x 0.8572 x serum creatinine (mg/dL); 8. The patient agrees and be able to follow planned study visits, treatment regimens, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Allergy is known to any monoclonal antibody or chemotherapy drug preparation ingredient; 2. Participate in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study; 3. Received systemic therapy with anti-tumor indications of Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon and immunoglobulin) within 2 weeks before the first administration; 4. Immunosuppressive drugs were administered within 4 weeks prior to the first study treatment, excluding nasal spray, inhalational or other topical corticosteroids or systemic glucocorticoids at physiological doses (i.e., not exceeding 10mg/ day of prednisone or equivalent doses of other corticosteroids), or to prevent contrast agent allergy; 5. Receive live attenuated vaccine within 4 weeks prior to the first study treatment or plan to receive live attenuated vaccine during the study; ? Note: Inactivated vaccine for seasonal influenza is allowed up to 4 weeks prior to initial administration;However, live attenuated influenza vaccine is not allowed; 6. Patients with known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. (patients with vitiligo or asthma in childhood have been completely relieved, and can be enrolled without any intervention after adulthood;People with type 1 diabetes who have good insulin control can also be enrolled; 7. He has an interstitial lung disease; 8. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation are known. 9. Suffers from other serious uncontrolled diseases, including but not limited to: Severe infection in the active phase or under poor clinical control; Hiv-infected persons (HIV-positive); ? with acute or chronic active hepatitis B (HBsAg positive with HBV DNA>1*103/ml) or acute or chronic active hepatitis c (HCV antibody positive with HCV RNA>15IU/ml); - Active tuberculosis, etc.;Grade III-IV congestive heart failure (New York Heart Association Grade), poorly controlled and clinically significant arrhythmias; Uncontrolled arterial hypertension (systolic pressure >=160mmHg or diastolic pressure >=100mmHg); - Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months prior to inclusion treatment; - Diseases requiring anticoagulant therapy with farwarin (coumarin); - Uncontrolled hypercalcemia (greater than 1.5 mmol/L calcium ion or calcium greater than 12 mg/dL or corrected serum calcium greater than ULN) or symptomatic hypercalcemia requiring continued bisphosphonate therapy; - Accompanied by other malignancies 10. Female patients who are pregnant or breastfeeding; 11. Other acute or chronic conditions, psychiatric disorders, or laboratory test abnormalities that may result in increased risk associated with study participation or study drug administration, or that interfere with the interpretation of study results, and that, at the investigator's discretion, classify patients as ineligible for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;OS; | — |
Countries
China
Contacts
Public ContactYu Jingping
Second People's Hospital of Changzhou City
Outcome results
None listed