Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer
Trial Parameters
Brief Summary
The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. The main question it aims to answer is: Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent, recurrent, or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab. Participants will be treated with Socazolimab/placebo + chemotherapy ± bevacizumab) for 6\~8 cycles (Q3w), following maintenance treatment of Socazolimab/placebo (Q3w).
Eligibility Criteria
Inclusion Criteria: * 1\. Able to understand and voluntarily signed written informed consent. Informed consent must be signed prior to specified study procedure. * 2\. Age ≥ 18 years and ≤75 years on the date of signing the informed consent, female. * 3\. ECOG Physical fitness score was 0 or 1. * 4\. Life expectancy ≥ 3 months. * 5\. Histologically confirmed cervical cancer that cannot be cured by surgery or radiotherapy/concurrent chemoradiotherapy. * 6\. Have at least one measurable tumor lesion examined by CT or MRI according to RECIST v1.1 criteria; * 7\. All subjects must provide archived or freshly obtained tumor tissue samples (formalin-fixed paraffin-embedded \[FFPE\] tissue wax blocks or at least 5 unstained tumor tissue section samples, preferably newly obtained tumor tissue samples) within the previous 5 years of randomization. * 8\. Laboratory examination results during the screening period indicate that the subject has good organ function. * 9\. Effective contraception sho