A Single-arm, Single Center, Phase II Study of RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer
There is currently no standardized treatment for patients who have undergone first-line standard treatment. In this study, We investigated the efficacy and safty of RC48 combined with Tislelizumab in the second-line treatment of patients with HER2 expression in recurrent cervical cancer.
• Female subjects aged from 18 to 75 years old；
• Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1；
• Have a life expectancy of at least 6 months, in the opinion of the investigator；
• Histologically or cytologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, or small cell (neuroendocrine) cervical cancer;
• Have measurable disease assessable by RECIST v1.1；
• Adequate haematological, hepatic and renal functions defined by the protocol； Pathologically diagnosed patients with HER2 expression （defined as: IHC 3+ or IHC 2+ or HC 1+）advanced cervical cancer ；Note：It is also acceptable if the subject has previous test results (confirmed by the investigator)；
• Negative blood pregnancy test at Screening for women of childbearing potential；Highly effective contraception for female subjects if the risk of conception exists；