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Platinum-sensitive Recurrent Ovarian CancerPhase 3HS-20089 PSOCNCT07821606

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

A Phase 3 study testing HS-20089+Bevacizumab, Dose 2：arboplatin+Paclitaxel+Bevacizumab and Dose 3：arboplatin+Gemcitabine+Bevacizumab in people with Platinum-sensitive Recurrent Ovarian Cancer, run by Hansoh BioMedical R&D Company at 39 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
HS-20089+Bevacizumab, Dose 2：arboplatin+Paclitaxel+Bevacizumab and Dose 3：arboplatin+Gemcitabine+Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
460 participants
Where
39 sitesChina
Study dates
1 Nov 2026to 30 Dec 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -
  • The main criteria are as follows:
  • 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
Show all 9Show fewer
  • Expected survival of more than 12 weeks.
  • 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.
  • Must be able to provide sufficient fresh or archived tumor tissue specimens that meet the requirements.

Who cannot join

  • 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

Trial locations and contacts

39 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ding Ma, PhD contact

0086-27-83662384

dingma424@126.com

Qinglei Gao, PhD contact

0086-27-83662384

qingleigao@hotmail.com

39 sites in 1 country

China39 sites

  • Anyang Cancer Hospital

    Anyang, Henan, 455000

  • National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 1000021

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310009

  • Zhejiang People's Hospital

    Hangzhou, Zhejiang, 310014

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • Shandong Cancer Hospital

    Jinan, Shandong, 030013

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

  • Linyi People's Hospital

    Linyi, Shandong, 276000

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi, 330006

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Yuebei People's Hospital

    Shaoguan, Guangdong, 512026

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110042

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 03001

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325015

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

Other trials in China

About this study

Official title: An Open-label, Multicentre, Randomized, Controlled Phase III Clinical Trial Comparing HS-20089 Plus Bevacizumab Versus Investigator's Choice of Platinum-based Chemotherapy Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer

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).

Being tested
HS-20089+Bevacizumab, Dose 2：arboplatin+Paclitaxel+Bevacizumab, Dose 3：arboplatin+Gemcitabine+Bevacizumab, Dose 4：arboplatin+Doxorubicin Hydrochloride Liposome+Bevacizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-20089+BevacizumabDrug

    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+BevacizumabDrug

    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+BevacizumabDrug

    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+BevacizumabDrug

    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.

Study groups in NCT07821606
Study groupRoleWhat they receive
Treatment group 1ExperimentalExperimental，Treatment group 1: HS-20089 in combination with Bevacizumab, administered according to the study protocol and as assessed by the investigator.
Receives: Drug: HS-20089+Bevacizumab
Treatment group 2-4Active comparatorActive Comparator，Treatment group 2-4，Carboplatin+Paclitaxel/Gemcitabine/Doxorubicin Hydrochloride Liposome+Bevacizumab：administered according to the study protocol and as assessed by the investigator
Receives: Drug: Dose 2：arboplatin+Paclitaxel+Bevacizumab; Drug: Dose 3：arboplatin+Gemcitabine+Bevacizumab; Drug: Dose 4：arboplatin+Doxorubicin Hydrochloride Liposome+Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Screening up to 3years

Secondary outcomes (7)

  1. PFS assessed by the investigator

    Progression-free survival (PFS) assessed by the investigator according to RECIST v1.1 criteria in the ITT population

    Measured: Screening up to 3 years（Planned date）

  2. OS

    Overall survival (OS) in the ITT population

    Measured: 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;

    Measured: 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;

    Measured: Screening up to study completion, with an average of 5 years

  5. 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.

    Measured: Screening up to study completion, with an average of 5 years

  6. TFST

    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

    Measured: Screening up to study completion, with an average of 5 years

  7. 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.

    Measured: Screening up to study completion, with an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion30 Dec 2029 (estimated)
  4. Study completion30 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
460 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07821606
Sponsor's protocol ID
HS-20089-302
Acronym
HS-20089 PSOC
Status last verified
Sep 2026
First submitted
2 Sep 2026
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HS-20089+Bevacizumab, Dose 2：arboplatin+Paclitaxel+Bevacizumab and Dose 3：arboplatin+Gemcitabine+Bevacizumab in people with Platinum-sensitive Recurrent Ovarian Cancer, run by Hansoh BioMedical R&D Company at 39 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ding Ma, PhD (0086-27-83662384, dingma424@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS assessed by BICR (time frame: Screening up to 3years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07821606.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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