Clinical trial · Interventional
Phase III Study of HS-20089 With Bevacizumab in Platinum-Sensitive Recurrent Ovarian Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Platinum-sensitive Recurrent Ovarian Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dose 2:arboplatin+Paclitaxel+Bevacizumab | Drug | — | UNRESOLVED |
| Dose 3:arboplatin+Gemcitabine+Bevacizumab | Drug | — | UNRESOLVED |
| Dose 4:arboplatin+Doxorubicin Hydrochloride Liposome+Bevacizumab | Drug | — | UNRESOLVED |
| HS-20089+Bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group 1
- description
- Experimental,Treatment group 1: HS-20089 in combination with Bevacizumab, administered according to the study protocol and as assessed by the investigator.
- interventionNames
- Drug: HS-20089+Bevacizumab
- type
- ACTIVE_COMPARATOR
- label
- Treatment group 2-4
- description
- 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
- interventionNames
- Drug: Dose 2:arboplatin+Paclitaxel+Bevacizumab
- Drug: Dose 3:arboplatin+Gemcitabine+Bevacizumab
- Drug: Dose 4:arboplatin+Doxorubicin Hydrochloride Liposome+Bevacizumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available