Ovarian Cancer
Conditions
Interventions
Intervention group: Ivonescimab Injection Combined with the Investigator - Selected Chemotherapy Regimen
Sponsors
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital.
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary signing of written informed consent. 2. Age at enrollment = 18 years and = 75 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 4. Expected survival = 3 months. 5. Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. 6. The subject has platinum-resistant recurrent disease, with platinum resistance defined as disease progression within 6 months after the last platinum-based chemotherapy. 7. According to RECIST v1.1, at least one measurable lesion. Note: Brain metastases cannot be considered target lesions; lesions after radiotherapy cannot be considered target lesions unless imaging clearly shows progression. 8. Previous treatment with anti-angiogenesis agents (including bevacizumab or small molecule TKIs) or PARP inhibitors is allowed. 9. The subject must provide 3-5 fresh biopsy or archived unstained tumor tissue FFPE (formalin-fixed, paraffin-embedded) slides for PD-L1 IHC testing (preferably from recently obtained tumor tissue samples). If the quality of samples is insufficient for PD-L1 IHC testing, additional unstained FFPE slides (3 slides) should be provided. If sufficient pathological slides cannot be provided or if prior PD-L1 testing results are available and approved by the investigator, partial or full exemption from providing slides may be granted. 10. The subject must meet the following criteria for good organ function: a) Hematologic (no use of blood products or colony-stimulating factors within 7 days prior to starting study treatment): i. White blood cell (WBC) count = 3.5 × 10?/L ii. Absolute neutrophil count (ANC) = 1.5 × 10?/L (1,500/mm³) iii. Platelet count = 100 × 10?/L (100,000/mm³) iv. Hemoglobin = 90 g/L b) Renal: i. Creatinine clearance (CrCl) = 50 mL/min or serum creatinine (Cr) = 1.5 × ULN ii. Urinary protein < 2+ or 24-hour urinary protein < 1.0 g c) Hepatic: i. Total bilirubin (TBil) = 1.5 × ULN; for subjects with liver metastasis or suspected/confirmed Gilbert's disease, TBil = 3 × ULN ii. AST and ALT = 2.5 × ULN; for subjects with liver metastasis, AST and ALT = 5 × ULN iii. Serum albumin (ALB) = 28 g/L d) Coagulation: i. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) = 1.5 × ULN (unless the subject is receiving anticoagulant therapy, in which case the coagulation parameters (PT/INR and aPTT) should be within the expected range for anticoagulant therapy). e) Cardiac: i. Left ventricular ejection fraction (LVEF) = 50%. 11. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (if the urine pregnancy test is inconclusive, a serum pregnancy test must be performed, and the serum result will be considered valid). If female subjects of childbearing potential engage in sexual activity with an untreated male partner, they must use an acceptable contraceptive method starting from screening and continue for 120 days after the last dose of the study drug. Whether contraception should be stopped after this period should be discussed with the investigator. 12. The subject is willing and able to comply with the study schedule, treatment protocol, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Currently participating in another clinical trial, or participated in another clinical trial within the past 4 weeks. 2. Known allergy to any component of the investigational drug. 3. Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies. 4. Patients who require the use of immunosuppressive drugs. 5. Patients who require systemic or absorbable topical corticosteroids (at immunosuppressive doses), or those who have used > 10 mg/day of prednisone or equivalent drugs within 2 weeks prior to taking the investigational drug. 6. Any active autoimmune disease or history of autoimmune disease, including but not limited to: active hepatitis, pneumonia, uveitis, colitis (inflammatory bowel disease), pituitaryitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, vitiligo, or resolved childhood asthma/atopic diseases. Asthma requiring intermittent use of bronchodilators or other medical interventions should also be excluded. 7. Patients with active infections requiring antimicrobial treatment (e.g., requiring antibiotics, antiviral, or antifungal therapy). 8. History of immune deficiency, including HIV-positive status or other acquired or congenital immunodeficiencies. 9. Poorly controlled cardiac symptoms or diseases, including but not limited to: New York Heart Association (NYHA) class 2 or higher heart failure, unstable angina, myocardial infarction within the past year, atrial fibrillation, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, PR interval > 250 ms, or QTc = 470 ms. 10. Arterial or venous thrombosis within the past 6 months. 11. Hypertension not well-controlled with antihypertensive therapy (systolic blood pressure = 140 mmHg and/or diastolic blood pressure = 90 mmHg); proteinuria = (++) and 24-hour total urine protein > 1.0 g. 12. Known history of HIV infection. Known active hepatitis B or active hepatitis C. 13. Coagulation disorders (INR > 2.0, PT > 16 s), bleeding tendency, or currently undergoing thrombolytic or anticoagulant therapy. 14. History of other malignancies within the past 5 years. 15. Received a live vaccine within 4 weeks prior to the first dose of the study drug. Note: Seasonal inactivated influenza vaccines are allowed. 16. Current significant gastrointestinal obstruction shown by imaging or clinical findings, or history of gastrointestinal fistula or perforation within the past 6 months. 17. History of severe bleeding tendency or coagulation dysfunction; imaging during screening showing tumors encircling important blood vessels or with significant necrosis or cavitation, where the investigator believes participation in the study may pose a bleeding risk. 18. History of substance abuse involving psychiatric drugs that cannot be controlled, or a history of psychiatric disorders. 19. Any other medical, psychiatric, or social factors that the investigator believes may affect the subject's rights, safety, informed consent, ability to complete the study, or the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor size; | — |
Countries
China
Contacts
Public ContactHongmin Chen
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital.
Outcome results
None listed