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

9 settembre 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

460

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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.
Comparatore attivo: 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
Droga: 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.
Droga: 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.
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PFS assessed by BICR
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PFS assessed by the investigator
Lasso di tempo: 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
Lasso di tempo: Through study completion, an average of 5 years
Overall survival (OS) in the ITT population
Through study completion, an average of 5 years
ORR
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hansoh BioMedical R&D Company

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

30 dicembre 2029

Completamento dello studio (Stimato)

30 dicembre 2031

Date di iscrizione allo studio

Primo inviato

2 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 settembre 2026

Primo Inserito (Effettivo)

16 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • HS-20089-302

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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