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NOT YET RECRUITING
NCT07230626
PHASE3

SYS6002 vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

412

Start Date

2025-11-20

Completion Date

2028-07-01

Last Updated

2025-11-17

Healthy Volunteers

No

Conditions

Interventions

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).