ovarian cancer
Conditions
Interventions
TLS-rich experimental group:Paclitaxel, Bevacizumab, Sintilimab
TLS-rich control group:Paclitaxel, Bevacizumab
TLS-poor experimental group:Paclitaxel, Bevacizumab
TLS-poor control group:Paclitaxel, Bevacizumab
Sponsors
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 years and more; No cognitive dysfunction; 2.Complete staging and satisfactory cytoreductive surgery were performed in the first operation, including hysterectomy, double adnexa, omentum, appendectomy and pelvic and abdominal cavity tumor implantation (residual tumor size: =1.5x10^9/L, HB>=90 g/L, PLT>=100x10^9/L;b) liver function was basically normal: TBIL=60mL/min, calculated according to the cockroft-gault formula: male GFR=(140-age)*BW/(Scr*72), female GFR= male *0.85;d) basically normal coagulation function: INR=12 weeks; 10.At least 4 weeks from the latest chemotherapy, and at least 4 half-life elution is required if anti-tumor biological products have been received; 11.Toxic and side effects caused by previous treatment should be restored to <=level 1 (CTCAE5.0); 12.Subject shall give informed consent to this study before the test and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. aged > 75 years old; 2. ECOG score >=3; 3. Pathological diagnosis is non-epithelial ovarian cancer or borderline tumor; 4. Gene detection indicates that the subject has BRCA1/2 mutation or HRD; 5. The patient has other invasive malignant tumors (except non-melanoma skin cancer) or previous malignant tumor treatment is contraindicated in the current treatment regimen; 6. Severe infections require intravenous antibiotics or hospitalization; 7. CNS disease unrelated to tumor, symptomatic brain metastasis; 8. Complete intestinal obstruction; 9. Allergic to paclitaxel or bevacizumab or sintilimab; 10. The patient has previously received immunotherapy, such as pd-1 antibody, pd-l1 antibody, CTLA4 antibody, etc; 11. The patient used immunosuppressive drugs within 4 weeks, not including the nasal spray, inhalation, or other ways of topical corticosteroids or physiological doses of systemic corticosteroids (i.e., no more than 10 mg/day prednisone or other equivalent dose glucocorticoids), allowing for treatment of diseases such as asthma, chronic obstructive pulmonary disease, breathing difficulties for the temporary use of glucocorticoid; 12. Previous medical history indicates severe medical complications; 13. The patient currently uses or recently (within 30 days prior to enrollment) used another drug or participates in another clinical study; 14. The patient has active, known or suspected autoimmune disease, or history of primary immunodeficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;progression-free survival at 6 months;progression-free survival at 12 months;overall survival; | — |
Countries
China
Contacts
Public ContactWang Yu
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Outcome results
None listed