Recruiting NCT06855069
HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HS-20089, Paclitaxel, Doxorubicin, Topotecan.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-center, Randomized, Open-label, Controlled, Phase III Clinical Study Evaluating HS-20089 vs. Investigator's Choice of Chemotherapy in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Overview
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of HS-20089 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
Interventions
- Drug HS-20089
HS-20089 dose 1 - Drug Paclitaxel
Paclitaxel dose 2 - Drug Doxorubicin
Doxorubicin dose 3 - Drug Topotecan
Topotecan dose 4
Primary outcome measures
- Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1 [Time frame: Screening up to study completion, an average of 1 year]
Secondary outcome measures (8)
- Overall Survival (OS) [Time frame: Screening up to study completion, an average of 1 year]
- Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1 [Time frame: Screening up to study completion, an average of 1 year]
- Duration of Response (DoR), assessed by site investigator as per RECIST 1.1 [Time frame: Screening up to study completion, an average of 1 year]
- Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1 [Time frame: Screening up to study completion, an average of 1 year]
- Objective Response Rate (ORR), assessed by BIRC as per RECIST 1.1 [Time frame: Screening up to study completion, an average of 1 year]
- Duration of Response (DoR), assessed by BIRC as per RECIST 1.1 [Time frame: Screening up to study completion, an average of 1 year]
- Disease Control Rate (DCR), assessed by BIRC as per RECIST 1.1 [Time frame: Screening up to study completion, an average of 1 year]
- Adverse Events [Time frame: Screening up to study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Voluntary participation and written informed consent.
- 18 years and older, female.
- Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- Patients must have platinum-resistant disease
- Be able to provide fresh or archived tumor tissue.
- At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) score: 0-1.
- With a life expectancy > 12 weeks.
- Adequate bone marrow reserve and organ function.
- Contraception is required during the trial.
Exclusion criteria
- Prior treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
- Previous or co-existing malignancies.
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.
- Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
- Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
- History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of HS-20089.
- Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with the study participation or study drug administration.
- Other inappropriate situation considered by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT06855069 · HS-20089-301