A Single-arm, Multicenter, Phase II Study of RC48 Plus Platinum With or Without Bevacizumab in the Treatment of HER-2 Expression Platinum-Sensitive Recurrent Ovarian Cancer
The purpose of this study is to evaluate the efficacy, safety, and quality of life scores of patients with HER2-expressing platinum-sensitive recurrent epithelial ovarian cancer treated with the combination therapy regimen of RC48 plus platinum with or without bevacizumab.
• Female subjects aged from 18 to 75 years old;
• Pathology confirmed the diagnosis of primary epithelial ovarian/fallopian tube/peritoneal carcinoma;
• Previous treatment lines ≥1 and ≤4, first-line treatment may include maintenance therapy after complete clinical or pathological response;Previously not receiving targeted HER2 drug therapy (including monoclonal antibodies and ADC drugs)
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry;
• Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
• Estimated life expectancy of more than 3 months;
• Local laboratory confirmed HER2 expression: IHC 1+, 2+, or 3+; Subjects were able to provide samples of the primary or metastatic site of the tumor for HER2 detection（Paraffin blocks, paraffin embedded sections or fresh tissue sections ）
• Adequate haematological, hepatic and renal functions defined by the protocol;
• Negative blood pregnancy test at Screening for women of childbearing potential; Highly effective contraception for female subjects if the risk of conception exists;