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

NCT07821606 · tracked via the Priya Life Science China tracker

Sponsor

Hansoh BioMedical R&D Company

Phase

Phase 3

Started

2026-11-01

Last updated

2026-09-16

Condition(s) studied

Platinum-sensitive Recurrent Ovarian Cancer

Investigational drug(s) / intervention(s)

HS-20089+BevacizumabDose 2：arboplatin+Paclitaxel+BevacizumabDose 3：arboplatin+Gemcitabine+BevacizumabDose 4：arboplatin+Doxorubicin Hydrochloride Liposome+Bevacizumab

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.

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.

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.

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.

Study 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).

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

PFS assessed by BICR — 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

Trial sites (39)

Facility	City	Region
Anhui Provincial Hospital	Hefei	Anhui
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing Municipality
Peking University Cancer Hospital	Beijing	Beijing Municipality
Peking Union Medical College Hospital	Beijing	Beijing Municipality
The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing Municipality
Chongqing University Cancer Hospital	Chongqing	Chongqing Municipality
The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
Yuebei People's Hospital	Shaoguan	Guangdong
Guangxi Medical University Cancer Hospital	Nanning	Guangxi
Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
Anyang Cancer Hospital	Anyang	Henan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
Hubei Cancer Hospital	Wuhan	Hubei
Hunan Cancer Hospital	Changsha	Hunan
Jiangsu Cancer Hospital	Nanjing	Jiangsu
Jiangsu Province Hospital	Nanjing	Jiangsu
Xuzhou Central Hospital	Xuzhou	Jiangsu
Jiangxi Maternal and Child Health Hospital	Nanchang	Jiangxi
Jiangxi Cancer Hospital	Nanchang	Jiangxi
The First Hospital of Jilin University	Changchun	Jilin
The Second Hospital of Jilin University	Changchun	Jilin
Shengjing Hospital of China Medical University	Shenyang	Liaoning
Liaoning Cancer Hospital	Shenyang	Liaoning
Shandong Cancer Hospital	Jinan	Shandong
Qilu Hospital of Shandong University	Jinan	Shandong
Linyi People's Hospital	Linyi	Shandong
Fudan University Shanghai Cancer Center	Shanghai	Shanghai Municipality
Shanxi Cancer Hospital	Taiyuan	Shanxi
The First Affiliated Hospital of Xi'an Jiaotong University	Xi’an	Shanxi
West China Second University Hospital, Sichuan University	Chengdu	Sichuan
The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
Tianjin Cancer Hospital	Tianjin	Tianjin Municipality
Yunnan Cancer Hospital	Kunming	Yunnan
The Second Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
Zhejiang People's Hospital	Hangzhou	Zhejiang
Zhejiang Cancer Hospital	Hangzhou	Zhejiang
The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

More Hansoh BioMedical R&D Company trials in China

A Study of HS-20122 in Patients With Advanced Solid Tumors Recruiting

A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis Starting soon

HS-20093 in Patients With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma Recruiting

A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer Recruiting

ARTEMIS-002: HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07821606 on ClinicalTrials.gov ↗ ← All trials in China