ovarian cancer
Conditions
Interventions
Experience group :Evaluation by laparoscopic
Experience group :albumin binding paclitaxel intraperitoneal neoadjuvant chemotherapy
Sponsors
Fudan University Shanghai Caner Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent; 2. Women aged 18 and less than 75 years old; 3. According to FIGO 2017, ovarian cancer was stage III; 4. Laparoscopic assessment showed that there were extensive miliary lesions or mesenteric contracture of the small intestine, and the endoscopic score was more than 10; 5. Histologically, the tumor was confirmed as high grade serous adenocarcinoma; 6. The ECoG PS of the eastern cancer cooperation group 0-2; 7. The estimated survival time was more than 3 months; 8. The laboratory results at screening must meet the following requirements: 1) Blood routine examination: white blood cell count (WBC) >=3.0x10^9/L, absolute neutrophil count (ANC) >=1.5x10^9/L, platelet count (PLT) >=100x10^9/L, hemoglobin (Hgb) >=90 g/L (no blood transfusion or erythropoietin dependence within 7 days); 2) Liver function: total bilirubin (TBIL) =60 ml/min; (Cockcroft Gault formula), and urine routine test results showed that urine protein (Upro) < 2 + or 24-hour urine protein < 1g; 9. Female subjects of reproductive age should be negative for urine or serum pregnancy tests within 3 days prior to administration of the first study drug (cycle 1, day 1). If the results of urine pregnancy test cannot be confirmed as negative, blood pregnancy test is required; 10. It is expected that the study protocol is in good compliance.
Exclusion criteria
Exclusion criteria: 1. Histology and pathology confirmed other types of ovarian tumors except high-grade serous adenocarcinoma; 2. Figo2017 ovarian cancer stage was other than stage III; 3. There were medical complications, which could not be tolerated by clinical and anesthesia evaluation; 4. There was a history of severe abdominal infection and peritonitis; 5. Currently participating in the intervention clinical research treatment, or receiving other trial drugs or using the test device within 4 weeks before the first administration; 6. Received live attenuated vaccine within 4 weeks before the first administration (or planned to receive live vaccine during the study period); Note: it is allowed to receive inactivated virus vaccine for seasonal influenza within 4 weeks before the first administration, but live attenuated influenza vaccine is not allowed; 7. Active autoimmune diseases requiring systemic treatment (e.g. use of disease remission drugs, corticosteroids or immunosuppressants) occurred within 2 years prior to the first administration. Alternative therapy (e.g. thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiency) is permitted; 8. Any unstable systemic disease: including but not limited to active infection, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure [New York Heart Association (NYHA) classification = " Severe arrhythmias, liver, kidney or metabolic diseases requiring drug treatment; 9. Have received solid organ or blood system transplantation except corneal transplantation; 10. Known history of HIV infection (i.e. HIV 1 / 2 antibody positive); 11) Tuberculosis, but not limited to the need for medical intervention at this stage; 12) In the 5 years before randomization, the patients suffered from malignant tumors other than ovarian cancer, including cervical carcinoma in situ, basal cell or squamous cell skin cancer, ductal carcinoma in situ or papillary thyroid carcinoma after radical operation; 13) Severe allergic reactions (= grade 3) have been reported to be associated with the active ingredients and / or any excipients of white protein bound paclitaxel and carboplatin; 14) Pregnant or lactating women or women who are going to be pregnant or lactating during the study period; 15) For women at risk of pregnancy, they did not agree to use high-efficiency contraceptives during the study drug use and within 90 days after the last administration; 16) Have a history of alcohol or drug abuse; 17) Other researchers think it is not suitable to be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Treatment completion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| mPFS;mOS;QoL; | — |
Countries
China
Contacts
Public ContactXiaojun Chen
Fudan University Shanghai Caner Center
Outcome results
None listed