This randomized, double-blind, 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent ovarian cancer.
Willingness to sign a written informed consent document .
Female, age ≥18 yrs and ≤70 yrs.
Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.
Platinum refractory: progression during the first platinum-based treatment or within 4 weeks after the first platinum-based primary therapy;
Patients received vascular endothelial growth factor(VEGF)/vascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors.
Patients received weekly paclitaxel therapy.
Has known allegies to Chiauranib, paclitaxel or any of the excipients.
Biological therapy, immunotherapy, hormonal therapy within 28 days prior to the first dose of study drug.
Parallel
chiauranib
Drug50mg orally once daily
Placebo
Drug50mg orally once daily
Paclitaxel
Drugat the first cycle, 60mg/m2, i.v infusion on day 1, 8 and 15 ; at the begining of the second cycle, after a comprehensive assessment , investigators decide whether to increase the dosage to 80mg/m2, i.v infusion on day 1, 8 and 15 ;
progression-free survival (PFS)
From the first time of treatment until the date of first documented progression or date of death from any cause, whichever comes first (Assessed by IRC)
overall survival (OS)
OS is defined as the length of time from treatment to death from any cause
overall response rate (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
duration of response (DOR)
From the first date of response until the date of first documented progression
Disease control rate (DCR)
DCR is defined as the Proportion of participants in partial, complete or stable desease according to RECIST 1.1. criteria
Quality of life (QoL)
QoL assessed by EORTC QLQ-OV28
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