RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorPeking Union Medical College Hospital

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

Treatment groups

30 Participants
are divided into 1 treatment group