This is a Phase III study evaluating the efficacy of HS-20089 in combination with bevacizumab versus investigator's choice of platinum-based chemotherapy in combination with bevacizumab in participants with platinum-sensitive recurrent ovarian cancer (PSOC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
460
Experimental(Treatment group 1):HS-20089 in combination with Bevacizumab, administered according to the study protocol and as assessed by the investigator.
Active Comparator(Treatment group2): Investigators selected treatment regimens based on participants' conditions(Paclitaxel or Doxorubicin Hydrochloride Liposome or Gemcitabine).All subjects will receive the investigator-selected drug in combination with Carboplatin and Bevacizumab, administered according to the study protocol and as assessed by the investigator.
Active Comparator(Treatment group3): Investigators selected treatment regimens based on participants' conditions(Paclitaxel or Doxorubicin Hydrochloride Liposome or Gemcitabine).All subjects will receive the investigator-selected drug in combination with Carboplatin and Bevacizumab, administered according to the study protocol and as assessed by the investigator.
PFS assessed by BICR
Progression-free Survival (PFS) assessed by blinded independent central review (BICR) according to RECIST v1.1 criteria in the ITT population
Time frame: Screening up to 3years
PFS assessed by the investigator
Progression-free survival (PFS) assessed by the investigator according to RECIST v1.1 criteria in the ITT population
Time frame: Screening up to 3 years(Planned date)
OS
Overall survival (OS) in the ITT population
Time frame: Through study completion, an average of 5 years
ORR
Objective response rate (ORR) assessed by BICR and by the investigator according to RECIST v1.1 criteria in the ITT population;
Time frame: Screening up to study completion,with an average of 5 years
DCR
Disease control rate (DCR) assessed by BICR and by the investigator according to RECIST v1.1 criteria in the ITT population;
Time frame: Screening up to study completion, with an average of 5 years
DoR
Duration of response (DoR) is defined as the time from the date of first documentation of objective response (complete response (CR) or partial response (PR) to the documentation of objective progression or to death due to any cause, whichever occurs first, as assessed by BICR and by the investigator according to RECIST v1.1 criteria in the ITT population.
Time frame: Screening up to study completion, with an average of 5 years
TFST
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Active Comparator(Treatment group4): Investigators selected treatment regimens based on participants' conditions(Paclitaxel or Doxorubicin Hydrochloride Liposome or Gemcitabine).All subjects will receive the investigator-selected drug in combination with Carboplatin and Bevacizumab, administered according to the study protocol and as assessed by the investigator.
Anhui Provincial Hospital
Hefei, Anhui, China
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Yuebei People's Hospital
Shaoguan, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
...and 29 more locations
Time to first subsequent treatment (TFST) is defined as the time from randomization to the date of initiation of the first subsequent anticancer therapy or death from any cause, whichever occurs first, as assessed by the investigators in the ITT population
Time frame: Screening up to study completion, with an average of 5 years
PSF2
Pogression-free survival 2 (PFS2) is defined as the time from randomization to the date of subsequent disease progression following the first investigator-assessed disease progression or death from any cause, whichever occurs first, in the ITT population.
Time frame: Screening up to study completion, with an average of 5 years