A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorGuangzhou Gloria Biosciences Co., Ltd.

About this trial

This is a randomized, double-blind, placebo-controlled phase III study to evaluate GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.

Eligibility criteria

Qualifiers

Signed the informed consent form.

Women aged ≥ 18 and ≤ 75 years.

ECOG of 0 or 1.

Life expectancy ≥ 12 weeks.

Disqualifiers

Patients with the opportunity to be cured by surgery and radiotherapy.

Received with concurrent chemoradiotherapy, adjuvant chemotherapy,neo- adjuvant chemotherapy within 4 weeks prior to randomization.

Active central nervous system (CNS) metastasis.

Patients with other malignancies prior to randomization. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast cancer) that have been cured are not excluded.

Trial design

Treatments tested in this trial

  • GLS-010
  • Placebo
  • paclitaxel
  • cisplatin
  • carboplatin
  • bevacizumab

Treatment groups

424 Participants
are divided into 2 treatment groups