NCT07230626

SYS6002 vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

A Randomized, Open-Label, Controlled, Multicenter Phase 3 Trial of SYS6002 Versus Chemotherapy of Physician's Choice in Recurrent or Metastatic Cervical Cancer After Platinum-containing Chemotherapy and Anti-PD-(L)1 Agent Therapy

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 412 (estimated)
• Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, open-label, controlled, multicenter phase Ⅲ clinical trial, which aims to evaluate the efficacy and safety of SYS6002 versus investigator's choice of chemotherapy in the treatment of participants with recurrent or metastatic cervical cancer who have failed platinum-containing chemotherapy and PD-1/L1 inhibitor therapy

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	SYS6002	SYS6002，intravenous injection
DRUG	Investigator's Choice of Chemotherapy	Investigator's choice of chemotherapy means the chemotherapy chosen by investigators/doctors to treat metastatic cervical cancer, including topotecan (1.2 mg/m\^2 of by IV on Days 1 to 5, every 21 days), gemcitabine (1000 mg/m\^2 by IV on Days 1 and 8, every 21 days), pemetrexed (500 mg/m\^2 by IV on Day 1, every 21 days), or docetaxel (75 mg/m\^2 by IV on Day 1, every 21 days).

Timeline

• Start date: 2025-11-20
• Primary completion: 2028-01-01
• Completion: 2028-07-01
• First posted: 2025-11-17
• Last updated: 2025-11-17