Phase III Study of HS-20089 With Bevacizumab in Platinum-Sensitive Recurrent Ovarian Cancer (HS-20089 PSOC)
2026년 9월 9일 업데이트: 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).
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
460
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Ding Ma, PhD
- 전화번호: 0086-27-83662384
- 이메일: dingma424@126.com
연구 연락처 백업
- 이름: Qinglei Gao, PhD
- 전화번호: 0086-27-83662384
- 이메일: qingleigao@hotmail.com
연구 장소
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Anhui
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Hefei, Anhui, 중국, 230001
- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100730
- Peking Union Medical College Hospital
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Beijing, Beijing Municipality, 중국, 100142
- Peking University Cancer Hospital
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Beijing, Beijing Municipality, 중국, 1000021
- National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences
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Chongqing Municipality
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Chongqing, Chongqing Municipality, 중국, 400030
- Chongqing University Cancer Hospital
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Chongqing, Chongqing Municipality, 중국, 400016
- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Xiamen, Fujian, 중국, 361003
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, 중국, 510060
- Sun Yat-sen University Cancer Center
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Shaoguan, Guangdong, 중국, 512026
- Yuebei People's Hospital
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Guangxi
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Nanning, Guangxi, 중국, 530021
- Guangxi Medical University Cancer Hospital
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Heilongjiang
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Harbin, Heilongjiang, 중국, 150081
- Harbin Medical University Cancer Hospital
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Henan
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Anyang, Henan, 중국, 455000
- Anyang Cancer Hospital
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Hubei
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Wuhan, Hubei, 중국, 430079
- Hubei Cancer Hospital
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Wuhan, Hubei, 중국, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Wuhan, Hubei, 중국, 430022
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, 중국, 410013
- Hunan Cancer Hospital
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Jiangsu
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Nanjing, Jiangsu, 중국, 210029
- Jiangsu Province Hospital
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Nanjing, Jiangsu, 중국, 210009
- Jiangsu Cancer Hospital
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Xuzhou, Jiangsu, 중국, 221009
- Xuzhou Central Hospital
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Jiangxi
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Nanchang, Jiangxi, 중국, 330006
- Jiangxi Maternal and Child Health Hospital
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Nanchang, Jiangxi, 중국, 330029
- Jiangxi Cancer Hospital
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Jilin
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Changchun, Jilin, 중국, 130021
- The First Hospital of Jilin University
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Changchun, Jilin, 중국, 130041
- The Second Hospital of Jilin University
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Liaoning
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Shenyang, Liaoning, 중국, 110004
- Shengjing Hospital of China Medical University
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Shenyang, Liaoning, 중국, 110042
- Liaoning Cancer Hospital
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Shandong
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Jinan, Shandong, 중국, 250012
- Qilu Hospital of Shandong University
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Jinan, Shandong, 중국, 030013
- Shandong Cancer Hospital
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Linyi, Shandong, 중국, 276000
- Linyi People's Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200032
- Fudan University Shanghai Cancer Center
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Shanxi
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Taiyuan, Shanxi, 중국, 03001
- Shanxi Cancer Hospital
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Xi’an, Shanxi, 중국, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
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Sichuan
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Chengdu, Sichuan, 중국, 610041
- West China Second University Hospital, Sichuan University
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Luzhou, Sichuan, 중국, 646000
- The Affiliated Hospital of Southwest Medical University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, 중국, 300060
- Tianjin Cancer Hospital
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Yunnan
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Kunming, Yunnan, 중국, 650118
- Yunnan Cancer Hospital
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, 중국, 310009
- The Second Affiliated Hospital of Zhejiang University
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Hangzhou, Zhejiang, 중국, 310014
- Zhejiang People's Hospital
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Wenzhou, Zhejiang, 중국, 325015
- The First Affiliated Hospital of Wenzhou Medical University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
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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
- 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.
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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Experimental(Treatment group 1):HS-20089 in combination with Bevacizumab, administered according to the study protocol and as assessed by the investigator.
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활성 비교기: 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
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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.
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.
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PFS assessed by BICR
기간: Screening up to 3years
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Progression-free Survival (PFS) assessed by blinded independent central review (BICR) according to RECIST v1.1 criteria in the ITT population
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Screening up to 3years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PFS assessed by the investigator
기간: Screening up to 3 years（Planned date）
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Progression-free survival (PFS) assessed by the investigator according to RECIST v1.1 criteria in the ITT population
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Screening up to 3 years（Planned date）
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OS
기간: Through study completion, an average of 5 years
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Overall survival (OS) in the ITT population
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Through study completion, an average of 5 years
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ORR
기간: Screening up to study completion，with an average of 5 years
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Objective response rate (ORR) assessed by BICR and by the investigator according to RECIST v1.1 criteria in the ITT population;
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Screening up to study completion，with an average of 5 years
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DCR
기간: Screening up to study completion, with an average of 5 years
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Disease control rate (DCR) assessed by BICR and by the investigator according to RECIST v1.1 criteria in the ITT population;
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Screening up to study completion, with an average of 5 years
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DoR
기간: Screening up to study completion, with an average of 5 years
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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.
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Screening up to study completion, with an average of 5 years
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TFST
기간: Screening up to study completion, with an average of 5 years
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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
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Screening up to study completion, with an average of 5 years
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PSF2
기간: Screening up to study completion, with an average of 5 years
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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.
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Screening up to study completion, with an average of 5 years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 11월 1일
기본 완료 (추정된)
2029년 12월 30일
연구 완료 (추정된)
2031년 12월 30일
연구 등록 날짜
최초 제출
2026년 9월 2일
QC 기준을 충족하는 최초 제출
2026년 9월 9일
처음 게시됨 (실제)
2026년 9월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 9일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HS-20089-302
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미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .