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;
History of malignant tumors other than cervical cancer, except for the following two cases：a. The patient had received a potentially curative treatment and had no evidence of the disease for 5 years；b. Successful resection of skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, cervical carcinoma in situ, and other carcinoma in situ was received；
Previous malignant disease (other than cervical cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)Previous stem cell allogeneic or parenchymal organ transplants；
Patients who had previously received other anti-tumor systemic therapy (including traditional Chinese medicine with anti-tumor indications) less than 4 weeks before the use of this study, or adverse events caused by previous treatment did not recover to ≤CTCAE grade 1 (except for alopecia and pigmentation)；
Had received a live vaccine within 4 weeks prior to the start of study dosing or planned to receive any vaccine (except for COVID-19 vaccine) during the study period；
Single group
RC48 + Tislelizumab
DrugRC48: intravenous drip, 2mg/kg, D1, repeated once every 2 weeks. Tislelizumab: intravenous drip, fixed dose 600 mg, D1, repeated once every 6 weeks.
Objective Response Rate（ORR）
Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.
Overall Survival(OS)
The time from the start of treatment with this study protocol to the time of all-cause death of patients.
Progression-free survival(PFS)
Time from initiation of study protocol treatment to disease progression (if occurring within 30 days of end of treatment) or death, as assessed by clinician or with or without radiographic progression.
Disease Control Rate (DCR)
Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated.
Duration of response（DOR）
The time between the onset of efficacy and confirmation of tumor progression
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