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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Platinum-sensitive Recurrent Ovarian Cancer
• Intervention / Treatment: Drug: HS-20089+Bevacizumab; Drug: Dose 2：arboplatin+Paclitaxel+Bevacizumab; Drug: Dose 3：arboplatin+Gemcitabine+Bevacizumab; Drug: Dose 4：arboplatin+Doxorubicin Hydrochloride Liposome+Bevacizumab

• Study Type: Interventional
• Enrollment (Estimated): 460
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ding Ma, PhD; Phone Number: 0086-27-83662384; Email: dingma424@126.com
• Study Contact Backup: Name: Qinglei Gao, PhD; Phone Number: 0086-27-83662384; Email: qingleigao@hotmail.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital
    • Beijing, Beijing Municipality, China, 100142
      • Peking University Cancer Hospital
    • Beijing, Beijing Municipality, China, 1000021
      • National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Chongqing University Cancer Hospital
    • Chongqing, Chongqing Municipality, China, 400016
      • The First Affiliated Hospital of Chongqing Medical University
  • Fujian
    • Xiamen, Fujian, China, 361003
      • The First Affiliated Hospital of Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center
    • Shaoguan, Guangdong, China, 512026
      • Yuebei People's Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Guangxi Medical University Cancer Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Henan
    • Anyang, Henan, China, 455000
      • Anyang Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
    • Xuzhou, Jiangsu, China, 221009
      • Xuzhou Central Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Maternal and Child Health Hospital
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Cancer Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The first hospital of jilin university
    • Changchun, Jilin, China, 130041
      • The Second Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital of China Medical University
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
    • Jinan, Shandong, China, 030013
      • Shandong Cancer Hospital
    • Linyi, Shandong, China, 276000
      • Linyi People's Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Shanghai Cancer Center
  • Shanxi
    • Taiyuan, Shanxi, China, 03001
      • Shanxi Cancer hospital
    • Xi’an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Second University Hospital, Sichuan University
    • Luzhou, Sichuan, China, 646000
      • The Affiliated Hospital of Southwest Medical University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Cancer Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Yunnan Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang People's Hospital
    • Wenzhou, Zhejiang, China, 325015
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group 1; Experimental，Treatment group 1: HS-20089 in combination with Bevacizumab, administered according to the study protocol and as assessed by the investigator.	Drug: HS-20089+Bevacizumab; 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 group 2-4; Active Comparator，Treatment group 2-4，Carboplatin+Paclitaxel/Gemcitabine/Doxorubicin Hydrochloride Liposome+Bevacizumab：administered according to the study protocol and as assessed by the investigator	Drug: Dose 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.; Drug: Dose 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.; Drug: Dose 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Screening up to 3years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS assessed by the investigator	Progression-free survival (PFS) assessed by the investigator according to RECIST v1.1 criteria in the ITT population	Screening up to 3 years（Planned date）
OS	Overall survival (OS) in the ITT population	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;	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;	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.	Screening up to study completion, with an average of 5 years
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	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.	Screening up to study completion, with an average of 5 years

Collaborators and Investigators

• Sponsor: Hansoh BioMedical R&D Company

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2031

Study Registration Dates

• First Submitted: September 2, 2026
• First Submitted That Met QC Criteria: September 9, 2026
• First Posted (Actual): September 16, 2026

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 9, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HS-20089-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No