Epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer
Conditions
Interventions
Experimental group:Atezolizumab combination antibody 5 mg/kg, intravenous injection, administered once every 3 weeks
Paclitaxel 175 mg/m^2, intravenous injection, administered once every 3 weeks
Carboplatin AUC = 5 (single maximum dose not exceeding 800 mg), intravenous injection, administered once every 3 weeks
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. Patients who require neoadjuvant chemotherapy by gynecologic oncologists designated by each center, including but not limited to: (1) Laparotomy or laparoscopy revealing that an R0 resection cannot be performed; (2) After comprehensive assessment based on the patient’s age, comorbidities, and ASA performance status, determining that the patient cannot tolerate primary debulking and thus requires neoadjuvant therapy; 4. Age 18-75 years; 5. Biopsy or surgical tumor specimen with high CD8+ tumor infiltrating lymphocytes (TILs) (>=20 positive cells per high-power field); 6. Eastern Cooperative Oncology Group (ECOG) score 0-1; 7. Life expectancy exceeds 3 months; 8. Has adequate organ function as defined by the following criteria: absolute neutrophil count >= 1.5 × 10^9 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; 9. 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); 9. 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; 10. History of a bone marrow or stem-cell transplant for any malignancy ; 11. Has a known history of immunodeficiency including human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease; 12. Symptomatic brain metastases (confirmed or suspected); 13. 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 3; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of no macroscopic residual disease (R0);Objective response rate;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactLan Chunyan
Sun Yat-sen University Cancer Center
Outcome results
None listed