Platinum-sensitive Recurrent Ovarian Cancer
Conditions
Brief summary
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).
Interventions
DRUGHS-20089+Bevacizumab
Experimental(Treatment group 1):HS-20089 in combination with Bevacizumab, administered according to the study protocol and as assessed by the investigator.
DRUGDose 2：arboplatin+Paclitaxel+Bevacizumab
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.
DRUGDose 3：arboplatin+Gemcitabine+Bevacizumab
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.
DRUGDose 4：arboplatin+Doxorubicin Hydrochloride Liposome+Bevacizumab
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.
Sponsors
Hansoh BioMedical R&D Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- The main criteria are as follows: 1. Female, aged 18 years or older (≥18 years) 2. Willing to voluntarily participate in this clinical trial, understand the study procedures, and able to provide written informed consent 3. Platinum-sensitive recurrence 4. ECOG PS: 0-1 5. Expected survival of more than 12 weeks. 6. Women of childbearing potential must be willing to use appropriate contraceptive measures from the time of signing informed consent until 6 months after the last dose administration and should not be breastfeeding. 7. Must be able to provide sufficient fresh or archived tumor tissue specimens that meet the requirements.
Exclusion criteria
* 1\. Prior treatment with topoisomerase I inhibitors; cytotoxic chemotherapy agents; small molecule inhibitors; antibody-drug conjugates (ADCs). 2\. Prior major surgery within 4 weeks prior to radonmization. 3. Residual toxicity from previous treatments graded ≥ Grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. 4\. History of a second primary malignancy. 5. Pleural effusion/ascites requiring clinical intervention); presence of pericardial effusion. 6\. Imaging evidence of bowel obstruction or symptoms/signs suggestive of bowel obstruction. 7 History of gastrointestinal perforation or fistula, or any grade of intra-abdominal abcess within 3 months prior to randonmization. 8 Participants known to have central nervous system (CNS) metastases and/or carcinomatous meningitis, either previously diagnosed or identified during screening. 9 Severe or poorly controlled hypertension. 10 Clinically significant bleeding symptoms 11 History of severe arterial/venous thromboembolic events 12. Clinically significant active viral, bacterial, or fungal infections requiring intravenous or oral pharmacological treatment 13. Known presence of an active infectious disease 14. History of interstitial lung disease of any grade
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS assessed by BICR | Screening up to 3years | Progression-free Survival (PFS) assessed by blinded independent central review (BICR) according to RECIST v1.1 criteria in the ITT population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS assessed by the investigator | Screening up to 3 years（Planned date） | Progression-free survival (PFS) assessed by the investigator according to RECIST v1.1 criteria in the ITT population |
| OS | Through study completion, an average of 5 years | Overall survival (OS) in the ITT population |
| ORR | Screening up to study completion，with an average of 5 years | Objective response rate (ORR) assessed by BICR and by the investigator according to RECIST v1.1 criteria in the ITT population; |
| DCR | Screening up to study completion, with an average of 5 years | Disease control rate (DCR) assessed by BICR and by the investigator according to RECIST v1.1 criteria in the ITT population; |
| DoR | Screening up to study completion, with an average of 5 years | 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. |
| TFST | Screening up to study completion, with an average of 5 years | 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 |
| PSF2 | Screening up to study completion, with an average of 5 years | 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. |
Countries
China
Contacts
CONTACTDing Ma, PhD
CONTACTQinglei Gao, PhD
Outcome results
None listed