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Efficacy and safety of Ivonescimab combined with chemotherapy for neoadjuvant treatment of advanced ovarian cancer: a single-arm, open, multicenter clinical study.

Efficacy and safety of Ivonescimab combined with chemotherapy for neoadjuvant treatment of advanced ovarian cancer: a single-arm, open, multicenter clinical study.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101645
Enrollment
Unknown
Registered
2025-04-28
Start date
2024-11-14
Completion date
Unknown
Last updated
2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer

Interventions

Ovarian cancer group:The patients received 4 cycles of Ivonescimab combined with chemotherapy before surgery

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Agree to sign the informed consent form; 2. 18 years 12 weeks; 8. Subjects of reproductive age must agree to use effective contraception during the trial; Serum or from women of childbearing age The urine pregnancy test must be negative; 9. Non-lactating patients; 10. Determine good organ function by: a) Hematology (no blood components and cell growth factors were used to support the treatment within 7 days prior to the start of the study): i. Absolute value of neutrophil ANC >= 1.5 ×10^9/L (1,500/mm3); ii. Platelet count >= 100 ×10^9/L (100,000/mm3); iii. Hemoglobin >= 90 g/L. b) Kidney: i. Creatinine clearance * (CrCl) calculated value >= 50 mL/min; * The Cockcroft-Gault formula will be used to calculate CrCl (Cockcroft-Gault formula) CrCL (mL/min) = [(140 - age) × weight (kg) × F]/ (SCr (mg/dL) × 72) Male F=1, female F=0.85; SCr = serum creatinine. ii. Urinary protein =28 g/L. d) Coagulation function: i. International Standardized ratio (INR) and activated partial thromboplastin time (APTT)=50%. 11. Fertile female subjects must have a urine or serum pregnancy within 3 days prior to the first dose Check (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required, based on the blood clearance pregnancy result), and the result is negative. If a fertile female subject has sex with an unsterilized male partner, the subject must use an acceptable contraceptive method since screening and must consent to continued use of the contraceptive method for 120 days after the last administration of the study drug; Whether to stop contraception after this time point should be discussed with the investigator; 12. Subject is willing and able to comply with scheduled visits, treatment protocols, laboratory tests, and other requirements of the study.

Exclusion criteria

Exclusion criteria: 1. Ovarian cancer, fallopian tube cancer, primary peritoneal cancer (e.g., germ cell tumor) of non-epithelial origin; Ovarian tumors with low malignant potential (e.g., borderline tumors); 2. Previous (within 5 years) or concurrent other malignancies, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.) and breast cancer without recurrence > 3 years after radical resection; 3. Subjects with active viral hepatitis B, inactive or asymptomatic hepatitis B virus (HBV) carriers (hepatitis B surface antigen [HBsAg] positive) with HBV DNA > 1000 IU/mL, and subjects with active viral hepatitis C. Note: Inactive or asymptomatic carriers, treated and stable hepatitis B subjects who meet the HBV DNA 10mg daily strong) for 14 days prior to taking the study drug Pine equivalent) or other immunosuppressive drugs for systemic treatment. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement doses >10mg per day of prednisone are permitted. Subjects were allowed to use topical, ocular, intra-articular, intranasal, and inhaled corticosteroids (minimal overall absorption). Physiological replacement doses of systemic corticost

Design outcomes

Primary

MeasureTime frame
rate of R0 resection;

Secondary

MeasureTime frame
Objective response rate;overal survival;progression free survival ;

Countries

China

Contacts

Public ContactHongyan Guo

Peking University Third Hospital

bysyghy@163.com+86 153 1121 6170

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026