epithelial ovarian cancer
Conditions
Interventions
Experimental grou:Bevacizumab + paclitaxel + carboplatin
Control group:Paclitaxel + carboplatin
Sponsors
Tianjin Medical University Cancer Institute & Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent was obtained 2. Female, aged 18-75 years. 3. Pathologically confirmed FIGO stage IIIC or IV advanced epithelial ovarian cancer; 4. ECOG score 0-2 [see Appendix 4 for details]. ; 5. At least one measurable target meeting RECIST v1.1 criteria; 6. Consent to provide the subject with formalin-fixed tumor tissue specimens or fresh biopsy tumor lesion tissue. At least 12 slides were provided; 7. Expected survival time =3 months; 8. Laboratory testing within 7 days prior to enrollment must meet the following criteria: a) neutrophil =1.5×10^9/L; b) platelet count =100×10^9/L; c) hemoglobin =90g/L (no transfusion of packed red blood cells within 2 weeks); d) serum creatinine =1.5× ULN and creatinine clearance =50mL/min; e) serum total bilirubin =1.5×ULN; f) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5×ULN; For patients with liver metastasis, ALT and AST=5×ULN; ALP=2.5×ULN (=5×ULN if there is tumor bone metastasis); g) 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; h) Thyroid function: free thyroid hormone 12-22pmol/L; Free triiodothyronine 2.8-7.1pmol/L; Thyroid stimulating hormone 0.27-4.2mIU/l 9. Women of childbearing age who were not surgically sterilized had to have a negative serum or urine HCG test within 7 days before study entry; And they must be non-lactating.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors within 5 years, or currently in the uncontrolled or persistent stage; 2. Currently participating in interventional clinical research treatment; 3. Patients with active bleeding or bleeding tendency; 4. Underwent major surgery within 4 weeks before the first dose of study drug (except for biopsy) or were expected to undergo major surgery during the study; 5. Severe unhealed wounds, ulcers or fractures; 6. Pregnant or lactating women; 7. Known to be allergic to bevacizumab or its excipients; 8. Have any serious or uncontrolled systemic diseases, including but not limited to: active autoimmune diseases, active HCV infection, active tuberculosis, severe arrhythmia, cardiac insufficiency, arteriovenous thrombosis, treated but uncontrolled hypertension, poor blood glucose, etc. 9. The investigator considered that there were other potential risks for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chemotherapy response score 3; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 rate;Progress free survival;Chemotherapy free interval;Time to first subsequent therapy; | — |
Countries
China
Contacts
Public ContactWenxin Liu
Tianjin Medical University Cancer Institute & Hospital
Outcome results
None listed