Phase III Study of HS-20089 With Bevacizumab in Platinum-Sensitive Recurrent Ovarian Cancer (HS-20089 PSOC)
9 septembre 2026 mis à jour par: 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).
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
460
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ding Ma, PhD
- Numéro de téléphone: 0086-27-83662384
- E-mail: dingma424@126.com
Sauvegarde des contacts de l'étude
- Nom: Qinglei Gao, PhD
- Numéro de téléphone: 0086-27-83662384
- E-mail: qingleigao@hotmail.com
Lieux d'étude
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Anhui
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Hefei, Anhui, Chine, 230001
- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100730
- Peking Union Medical College Hospital
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Beijing, Beijing Municipality, Chine, 100142
- Peking University Cancer Hospital
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Beijing, Beijing Municipality, Chine, 1000021
- National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Chine, 400030
- Chongqing University Cancer Hospital
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Chongqing, Chongqing Municipality, Chine, 400016
- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Xiamen, Fujian, Chine, 361003
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, Chine, 510060
- Sun Yat-Sen University Cancer Center
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Shaoguan, Guangdong, Chine, 512026
- Yuebei People's Hospital
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Guangxi
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Nanning, Guangxi, Chine, 530021
- Guangxi Medical University Cancer Hospital
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Heilongjiang
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Harbin, Heilongjiang, Chine, 150081
- Harbin Medical University Cancer Hospital
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Henan
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Anyang, Henan, Chine, 455000
- Anyang Cancer Hospital
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Hubei
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Wuhan, Hubei, Chine, 430079
- Hubei Cancer Hospital
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Wuhan, Hubei, Chine, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Wuhan, Hubei, Chine, 430022
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, Chine, 410013
- Hunan Cancer Hospital
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Jiangsu
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Nanjing, Jiangsu, Chine, 210029
- Jiangsu Province Hospital
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Nanjing, Jiangsu, Chine, 210009
- Jiangsu Cancer Hospital
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Xuzhou, Jiangsu, Chine, 221009
- Xuzhou Central Hospital
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Jiangxi
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Nanchang, Jiangxi, Chine, 330006
- Jiangxi Maternal and Child Health Hospital
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Nanchang, Jiangxi, Chine, 330029
- Jiangxi Cancer Hospital
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Jilin
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Changchun, Jilin, Chine, 130021
- The first hospital of jilin university
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Changchun, Jilin, Chine, 130041
- The Second Hospital of Jilin University
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Liaoning
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Shenyang, Liaoning, Chine, 110004
- Shengjing Hospital of China Medical University
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Shenyang, Liaoning, Chine, 110042
- Liaoning Cancer Hospital
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Shandong
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Jinan, Shandong, Chine, 250012
- Qilu Hospital of Shandong University
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Jinan, Shandong, Chine, 030013
- Shandong Cancer Hospital
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Linyi, Shandong, Chine, 276000
- Linyi People's Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200032
- Fudan University Shanghai Cancer Center
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Shanxi
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Taiyuan, Shanxi, Chine, 03001
- Shanxi Cancer hospital
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Xi’an, Shanxi, Chine, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
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Sichuan
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Chengdu, Sichuan, Chine, 610041
- West China Second University Hospital, Sichuan University
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Luzhou, Sichuan, Chine, 646000
- The Affiliated Hospital of Southwest Medical University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Chine, 300060
- Tianjin Cancer Hospital
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Yunnan
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Kunming, Yunnan, Chine, 650118
- Yunnan Cancer Hospital
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Zhejiang
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Hangzhou, Zhejiang, Chine, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, Chine, 310009
- The Second Affiliated Hospital of Zhejiang University
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Hangzhou, Zhejiang, Chine, 310014
- Zhejiang People's Hospital
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Wenzhou, Zhejiang, Chine, 325015
- The First Affiliated Hospital of Wenzhou Medical University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
-
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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PFS assessed by BICR
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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PFS assessed by the investigator
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 novembre 2026
Achèvement primaire (Estimé)
30 décembre 2029
Achèvement de l'étude (Estimé)
30 décembre 2031
Dates d'inscription aux études
Première soumission
2 septembre 2026
Première soumission répondant aux critères de contrôle qualité
9 septembre 2026
Première publication (Réel)
16 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- HS-20089-302
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .