About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- RC48 + Tislelizumab