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Phase III Study of HS-20089 With Bevacizumab in Platinum-Sensitive Recurrent Ovarian Cancer

ConditionPlatinum-sensitive Recurrent Ovarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHansoh BioMedical R&D Company

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female, aged 18 years or older (≥18 years)

Willing to voluntarily participate in this clinical trial, understand the study procedures, and able to provide written informed consent

Platinum-sensitive recurrence

ECOG PS: 0-1

Disqualifiers

1. Prior treatment with topoisomerase I inhibitors; cytotoxic chemotherapy agents; small molecule inhibitors; antibody-drug conjugates (ADCs).

Trial design

Design model

Parallel

Treatments tested in this trial

  • HS-20089+Bevacizumab

    Drug

    Experimental(Treatment group 1):HS-20089 in combination with Bevacizumab, administered according to the study protocol and as assessed by the investigator.

  • Dose 2：arboplatin+Paclitaxel+Bevacizumab

    Drug

    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.

  • Dose 3：arboplatin+Gemcitabine+Bevacizumab

    Drug

    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.

  • Dose 4：arboplatin+Doxorubicin Hydrochloride Liposome+Bevacizumab

    Drug

    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.

Treatment groups

460 Participants
are divided into 2 treatment groups
Group A: Treatment group 1Experimental treatment 1 intervention
Group B: Treatment group 2-4Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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）
2

OS

Overall survival (OS) in the ITT population

Time frame
Through study completion, an average of 5 years
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hansoh BioMedical R&D Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: