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

9. September 2026 aktualisiert von: 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).

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

460

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: 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.
Aktiver Komparator: 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
Arzneimittel: 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.
Arzneimittel: 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.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PFS assessed by BICR
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PFS assessed by the investigator
Zeitfenster: 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
Zeitfenster: Through study completion, an average of 5 years
Overall survival (OS) in the ITT population
Through study completion, an average of 5 years
ORR
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hansoh BioMedical R&D Company

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

30. Dezember 2029

Studienabschluss (Geschätzt)

30. Dezember 2031

Studienanmeldedaten

Zuerst eingereicht

2. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. September 2026

Zuerst gepostet (Tatsächlich)

16. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • HS-20089-302

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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