Phase III Study of HS-20089 With Bevacizumab in Platinum-Sensitive Recurrent Ovarian Cancer (HS-20089 PSOC)
9 de septiembre de 2026 actualizado por: 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).
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
460
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ding Ma, PhD
- Número de teléfono: 0086-27-83662384
- Correo electrónico: dingma424@126.com
Copia de seguridad de contactos de estudio
- Nombre: Qinglei Gao, PhD
- Número de teléfono: 0086-27-83662384
- Correo electrónico: qingleigao@hotmail.com
Ubicaciones de estudio
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Anhui
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Hefei, Anhui, Porcelana, 230001
- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100730
- Peking Union Medical College Hospital
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Beijing, Beijing Municipality, Porcelana, 100142
- Peking University Cancer Hospital
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Beijing, Beijing Municipality, Porcelana, 1000021
- National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Porcelana, 400030
- Chongqing University Cancer Hospital
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Chongqing, Chongqing Municipality, Porcelana, 400016
- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Xiamen, Fujian, Porcelana, 361003
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510060
- Sun Yat-sen University Cancer Center
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Shaoguan, Guangdong, Porcelana, 512026
- Yuebei People's Hospital
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Guangxi
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Nanning, Guangxi, Porcelana, 530021
- Guangxi Medical University Cancer Hospital
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Heilongjiang
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Harbin, Heilongjiang, Porcelana, 150081
- Harbin Medical University Cancer Hospital
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Henan
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Anyang, Henan, Porcelana, 455000
- Anyang Cancer Hospital
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Hubei
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Wuhan, Hubei, Porcelana, 430079
- Hubei Cancer Hospital
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Wuhan, Hubei, Porcelana, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Wuhan, Hubei, Porcelana, 430022
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, Porcelana, 410013
- Hunan Cancer Hospital
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210029
- Jiangsu Province Hospital
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Nanjing, Jiangsu, Porcelana, 210009
- Jiangsu Cancer Hospital
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Xuzhou, Jiangsu, Porcelana, 221009
- Xuzhou Central Hospital
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Jiangxi
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Nanchang, Jiangxi, Porcelana, 330006
- Jiangxi Maternal and Child Health Hospital
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Nanchang, Jiangxi, Porcelana, 330029
- Jiangxi Cancer Hospital
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Jilin
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Changchun, Jilin, Porcelana, 130021
- The First Hospital of Jilin University
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Changchun, Jilin, Porcelana, 130041
- The Second Hospital of Jilin University
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Liaoning
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Shenyang, Liaoning, Porcelana, 110004
- Shengjing Hospital of China Medical University
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Shenyang, Liaoning, Porcelana, 110042
- Liaoning Cancer Hospital
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Shandong
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Jinan, Shandong, Porcelana, 250012
- Qilu Hospital of Shandong University
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Jinan, Shandong, Porcelana, 030013
- Shandong Cancer Hospital
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Linyi, Shandong, Porcelana, 276000
- Linyi People's Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200032
- Fudan University Shanghai Cancer Center
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Shanxi
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Taiyuan, Shanxi, Porcelana, 03001
- Shanxi Cancer Hospital
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Xi’an, Shanxi, Porcelana, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
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Sichuan
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Chengdu, Sichuan, Porcelana, 610041
- West China Second University Hospital, Sichuan University
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Luzhou, Sichuan, Porcelana, 646000
- The Affiliated Hospital of Southwest Medical University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Porcelana, 300060
- Tianjin Cancer Hospital
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Yunnan
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Kunming, Yunnan, Porcelana, 650118
- Yunnan Cancer Hospital
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, Porcelana, 310009
- The Second Affiliated Hospital of Zhejiang University
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Hangzhou, Zhejiang, Porcelana, 310014
- Zhejiang People's Hospital
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Wenzhou, Zhejiang, Porcelana, 325015
- The First Affiliated Hospital of Wenzhou Medical University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PFS assessed by BICR
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PFS assessed by the investigator
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de noviembre de 2026
Finalización primaria (Estimado)
30 de diciembre de 2029
Finalización del estudio (Estimado)
30 de diciembre de 2031
Fechas de registro del estudio
Enviado por primera vez
2 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de septiembre de 2026
Publicado por primera vez (Actual)
16 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- HS-20089-302
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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