newly diagnosed ovarian cancer
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Suzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent form (ICF) has been signed voluntarily and fully understood the content of this study; 2. Female patients aged 18-75 years old; 3. ECoG score 0-2; 4. FIGO stage was stage III or stage IV, including inoperable patients with stage III or IV ovarian cancer; 5. At least one measurable index in accordance with RECIST v1.1 standard; 6. They agreed to provide formalin fixed tumor tissue samples or fresh biopsy tumor tissue. At least 12 slices were provided; 7. The expected survival time was more than 3 months; 8. Laboratory tests within 7 days before enrollment must meet the following criteria: (1) Neutrophils >=1.5x10^9/L; (2) Platelet >=100x10^9/L; (3) Hemoglobin >=90 g/L (no transfusion of concentrated red blood cells within 2 weeks); (4) Serum creatinine =50ml/min; (5) Serum total bilirubin <=1.5 ULN; (6) In patients with liver metastasis, ALT and AST <=5 ULN; ALP <=2.5 ULN (if there is bone metastasis of tumor, <=5 ULN); (7) International normalized ratio (INR) or prothrombin time (PT) <=1.5 ULN, unless the subject is receiving anticoagulant therapy; activated partial thromboplastin time (APTT) <=1.5 ULN unless the subject is receiving anticoagulant therapy; (8) Thyroid function: free thyroid hormone 12-22 pmol/L; free triiodothyronine 2.8-7.1 pmol/L; thyroid stimulating hormone 0.27-4.2 mIU/L; 9. Non surgically sterilized women of childbearing age must be negative for hCG in serum or urine within 7 days prior to study enrollment, and must be non lactating.
Exclusion criteria
Exclusion criteria: (1) The patient has any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma has been completely relieved in childhood, and can be included in adults without any intervention; patients Asthma requiring medical intervention with bronchodilators could not be included; (2) Patients who are using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dosage > 10mg / D, prednisone or other effective hormones) and continue to use them within 2 weeks before enrollment; (3) Severe allergic reactions to other monoclonal antibodies occurred; (4) There are clinical symptoms or diseases that can not be well controlled, such as heart failure above NYHA 2 grade; unstable angina pectoris; myocardial infarction within 1 year; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; QTc > 470ms; (5) The patient had previously received anti-PD-1, PD-L1 antibody treatment, or was known to be allergic to antibody drugs; (6) Patients who had previously received chemotherapy and surgery, less than 4 weeks before the study medication after the completion of treatment (the last medication); patients whose half-life of molecular targeted therapy (including oral targeted drugs for other clinical trials) was less than 5 drugs from the first study medication, or the adverse events (except hair loss) caused by previous treatment did not recover to =38.5 degree C, or baseline WBC count > 15x10^9/L; (8) Live vaccines were administered less than 4 weeks before the study or during the study period; (9) Patients with congenital or acquired immune deficiency (such as HIV infected people); (10) Thyroid function was abnormal in the past, and the thyroid function could not be maintained in the normal range under the condition of drug treatment; (11) HBV DNA > 500 IU/ml, HCV RNA >10 ^ 3 copies / ml, HBsAg + and HCV antibody positive patients; (12) The patients had other malignant tumors in the past 5 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ; for patients with previous recurrent ovarian cancer complicated with breast cancer, except those with no recurrence > 3 days after radical mastectomy); (13) According to the researcher's judgment, the patient has other factors that may affect the results of the study or cause the study to be terminated. For example, alcoholism, drug abuse, other serious diseases (including mental illness) that need to be treated together, serious laboratory test abnormalities, and family or social factors may affect the safety of patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CRS3 rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR rate;progressing-free survival; | — |
Countries
China
Contacts
Public ContactChen Youguo
The First Affiliated Hospital of Suzhou University
Outcome results
None listed