Efficacy and Safety of Socazolimab Combined With Chemotherapy With or Without Bevacizumab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer: A Randomized, Double-blind, Placebo-controlled Phase III Study
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).
• 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 should be used by fertile female subjects from the signing of informed consent until 180 days after the last administration of the study drug.