This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of HS-20089 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
468
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGProgression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Overall Survival (OS)
Time frame: Screening up to study completion, an average of 1 year
Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Duration of Response (DoR), assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Objective Response Rate (ORR), assessed by BIRC as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Duration of Response (DoR), assessed by BIRC as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Disease Control Rate (DCR), assessed by BIRC as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Adverse Events
Time frame: Screening up to study completion, an average of 1 year
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Topotecan dose 4