ovarian cancer
Conditions
Interventions
Experimental group:Ivonescimab 20mg/kg intravenously in 21-day cycle
Experimental group:Paclitaxel 175mg/m2 intravenously in 21-day cycle
Experimental group:Carboplatin AUC=5 intravenously in 21-day cycle
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent Form (ICF); 2. Newly diagnosed stage IIIC-IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 3. Primary debulking surgery is unlikely to achieve R0 resection or the patient cannot tolerate surgery, including but not limited to: Stage IIIC Fagotti score = 8 points; Stage IV patients; For stage IIIC patients with a Fagotti score < 8, the investigator will conduct a comprehensive assessment based on the patient’s age, comorbidities, and ASA performance status. If the investigator considers that the patient cannot tolerate primary debulking surgery and requires neoadjuvant therapy, they may be enrolled. 4. Age 18-75 years 5. Eastern Cooperative Oncology Group (ECOG) score 0-2; 6. Life expectancy exceeds 3 months; 7. Has adequate organ function as defined by the following criteria: absolute neutrophil count = 1.5 × 109 cells, platelets = 100 × 109 cells, hemoglobin = 90 g/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 × upper limit of normal (UNL), total bilirubin < 1.5 × UNL, serum creatinine < 1.5 × UNL; 8. Females of childbearing potential should have a negative serum or urine pregnancy test prior to receiving the first dose of study treatment; and should be willing to use one acceptable contraception (i.e., oral contraceptives, condoms, intrauterine devices [IUDs]) throughout the period of taking study treatment and for at least 6 months after the last dose of study drug(s).
Exclusion criteria
Exclusion criteria: 1. Histology is mucinous adenocarcinoma or low-grade serous adenocarcinoma; 2. Known or suspected allergy to any of study drugs; 3. Has an active autoimmune disease requiring systemic therapy (i.e., with use of disease modifying drugs, corticosteroids or immunosuppressive drugs) in past 2 years. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted; 4. Concurrent medical condition requiring the use of systemic steroid therapy (dose > 10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to the first dose of study intervention; 5. Has an active infection requiring systemic therapy; 6. Clinically significant cardiovascular diseases, including but not limited to congestive heart failure (New York heart association [NYHA] class > 2 or left ventricular ejection fraction (LVEF) upper limit of normal); 10. History of another malignancy in the previous 3 years, with a disease-free interval of < 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy; 11. History of a bone marrow or stem-cell transplant for any malignancy ; 12. Has a known history of immunodeficiency including human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease; 13. Symptomatic brain metastases (confirmed or suspected); 14. Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of CRS (chemotherapy response score) 3; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of no macroscopic residual disease (R0);Objective response rate;Progression-free survival;Overall survival;Safety;Single-cell transcriptome analysis;Genome-Wide sequencing analysis;Gut flora metagenomic analysis ; | — |
Countries
China
Contacts
Public ContactLan Chunyan
Sun Yat-sen University Cancer Center
Outcome results
None listed