This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 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
440
National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, 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
Response Rate (RR) assessed by RECIST 1.1 and Gynaecologic Cancer Intergroup (GCIG) criteria
Time frame: Screening up to study completion, an average of 1 year
CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria
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