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

2026年9月9日 更新者：Hansoh BioMedical R&D Company

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).

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

460

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：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.
有源比较器：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
药品：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.
药品：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.
药品：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
PFS assessed by BICR
大体时间：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
Screening up to 3years

次要结果测量

结果测量
措施说明
大体时间
PFS assessed by the investigator
大体时间：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
Screening up to 3 years（Planned date）
OS
大体时间：Through study completion, an average of 5 years
Overall survival (OS) in the ITT population
Through study completion, an average of 5 years
ORR
大体时间：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;
Screening up to study completion，with an average of 5 years
DCR
大体时间：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;
Screening up to study completion, with an average of 5 years
DoR
大体时间：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.
Screening up to study completion, with an average of 5 years
TFST
大体时间：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
Screening up to study completion, with an average of 5 years
PSF2
大体时间：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.
Screening up to study completion, with an average of 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hansoh BioMedical R&D Company

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2029年12月30日

研究完成 (估计的)

2031年12月30日

研究注册日期

首次提交

2026年9月2日

首先提交符合 QC 标准的

2026年9月9日

首次发布 (实际的)

2026年9月16日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月9日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • HS-20089-302

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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