Efficacy and Safety of Distamab Vedotin Combined With Carboplatin for Advanced Ovarian Cancer in the First Line Treatment

Inclusion criteria

• Stage II-IV epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer confirmed by histopathological examination;
• Received the first tumor cell debulking surgery before enrollment and achieved R0 or R1 resection;
• HER2 expression: IHC 2+ or 3+;
• Had not received chemotherapy before enrollment;
• ECOG PS ≤ 2;
• Expected survival period ≥ 3 months;
• Adequate organ function. During the screening period, the following criteria should be met (normal values are based on the clinical trial center): Left ventricular ejection fraction ≥ 50%; Hemoglobin ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); When there is no liver metastasis, ALT and AST ≤ 2.5 × ULN, and when there is liver metastasis, ALT and AST ≤ 5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance rate (CrCl) ≥ 50 mL/min according to the Cockcroft-Gault formula;
• Non-pregnant women;
• Signed a written informed consent form before the trial.

Exclusion criteria

• Within one month prior to the start of treatment, the subject had received other anti-tumor treatments (such as radiotherapy, immunotherapy);
• The subject had central nervous system diseases or brain metastases;
• Had previously experienced grade II or above peripheral neuropathy;
• Had an uncontrolled serious disease that would affect the subject's ability to receive treatment according to the study protocol: such as severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
• Had a history of other malignant tumors within the past 5 years (excluding cured skin basal cell carcinoma and cervical cancer);
• Had known allergies to the study-related drugs or their excipients or was intolerant to them;
• Was participating in other clinical trials at the same time;
• Subjects judged by the researcher to be unsuitable for this study.