Iparomlimab and Tuvonralimab Plus Chemotherapy as Neoadjuvant Therapy for Ovarian Cancer（Phase II）

Inclusion criteria

• Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma, FIGO 2014 stage III-IV disease;
• Female patients aged 18 to 75 years;
• Willing and able to provide written informed consent and comply with study visits and protocol-specified procedures;
• Candidates for cytoreductive surgery (debulking surgery);
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Estimated life expectancy of at least 6 months;
• Women of childbearing potential must agree to use effective contraception during the study period, and a negative serum or urine pregnancy test is required prior to enrollment;
• Adequate organ function.

Exclusion criteria

• Histological subtypes other than epithelial ovarian carcinoma, including mucinous carcinoma and clear cell carcinoma.
• Pregnant women or patients whose most recent pregnancy was terminated within 2 weeks prior to screening.
• Clinically significant hydronephrosis not amenable to stenting or nephrostomy, or presence of CNS metastases or carcinomatous meningitis.
• History of other malignancies within 3 years, except for adequately treated curable cancers (e.g., skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, or carcinoma in situ of the breast).
• Prior treatment with immune checkpoint inhibitors or other immunomodulatory anticancer therapies.
• Major surgery within 4 weeks before study treatment, or planned major surgery during the study period.
• Severe cardiovascular or cerebrovascular disease.
• Unresolved ≥ Grade 2 toxicity (CTCAE v5.0) from prior anticancer therapy, excluding alopecia.
• Known hypersensitivity to study drugs or their components.
• Any condition that may compromise patient safety or interfere with study evaluation, as judged by the investigator.