Ovarian Cancer
Conditions
Interventions
Test group:Neoadjuvant immunochemotherapy for ovarian cancer
Sponsors
First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined this study, signed the informed consent form, and had good compliance; 2. FIGO staging is III-C to IV for newly diagnosed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 3. A specialized gynecological oncologist designated by the center judged that it was difficult to achieve R0 resection with initial tumor debulking or that the patient could not tolerate surgery, including but not limited to: III-C stage Fagotti score >= 8 points; IV stage patients; those with III-C stage and Fagotti score = 1.5 × 10^9/L, platelet count >= 100 × 10^9/L, hemoglobin >= 90 g/L, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) <= 2.5 × normal upper limit (ULN) (for patients with liver metastases <= 5 × ULN) or Alkaline Phosphatase <= 2.5 × ULN (or <= 5 × ULN in the case of liver or bone metastases), total bilirubin <= 1.5 × ULN, serum creatinine <= 1.5 × ULN; 9. Subjects with potential fertility must use at least one medically approved contraceptive method (such as an intrauterine device, contraceptive pills, or condoms) during the study treatment and for 180 days after the study treatment ends; and the serum/urine HCG test must be negative before the first medication; they must also not be breastfeeding.
Exclusion criteria
Exclusion criteria: Objects that meet any of the following criteria will be excluded from this study: 1. Organ pathology indicating mucinous adenocarcinoma or low-grade serous adenocarcinoma; 2. Known allergies to any drugs in the study; 3. Active autoimmune diseases requiring systemic treatment within 2 years prior to the start of the study treatment, or autoimmune diseases judged by the investigator to have a possibility of relapse or planned treatment. Exceptions include: skin diseases that do not require systemic treatment (such as vitiligo, alopecia, psoriasis, or eczema); hypothyroidism caused by autoimmune thyroiditis requiring only stable doses of hormone replacement therapy; type 1 diabetes requiring only stable doses of insulin replacement therapy; childhood asthma completely resolved with no intervention needed in adulthood; and diseases judged by the investigator to not relapse without external triggering factors; 4. Subjects who required systemic treatment with glucocorticoids (>10 mg/day of prednisone equivalent) or other immunosuppressive drugs within 14 days prior to the first dose of medication. Exceptions: The use of inhaled, ophthalmic, or topical glucocorticoids is allowed if there is no active autoimmune disease, or if the dose does not exceed 10 mg/day of prednisone or equivalent for other glucocorticoid treatments; 5. Active infections requiring systemic treatment; 6. History of severe cardiovascular and cerebrovascular disease: occurrence of cerebrovascular accidents (excluding lacunar infarcts, minor cerebral ischemia, or transient ischemic attacks) within 6 months prior to the first dose of the investigational drug, myocardial infarction, unstable angina, poorly controlled arrhythmias (including QTc intervals of men =450ms, women >=470ms) (QTc intervals calculated using the Fridericia formula); NYHA functional classification > II or left ventricular ejection fraction (LVEF) =2000 IU/ml or 10^4 copies/ml; HCV antibody positive and HCV virus copy number > normal upper limit); 10. Diagnosis of any other malignancy within 3 years prior to screening (with exceptions for in situ cancers that have received potentially curative treatment such as breast cancer, bladder cancer, cervical carcinoma in situ, or skin basal cell carcinoma or squamous cell carcinoma); 11. Known history of allogeneic organ transplant and allogeneic hematopoietic stem cell transplant; 12. HIV positive; 13. Symptomatic brain metastases (confirmed or suspected); 14. The investigator deems the subject unsuitable for participation in this clinical study due to any clinical or laboratory abnormalities or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate;progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Chemotherapy remission score;pathologic complete response;objective response rate;disease control rate;adverse event;Incidence of immune related adverse events; | — |
Countries
China
Contacts
Public ContactBo Yang
First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed