Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorAnhui Provincial Hospital
About this trial
This study is a single-arm, open, multicenter, exploratory clinical study to observe and evaluate the efficacy and safety of fluazoparib combined with apatinib mesylate in the treatment of patients with ovarian cancer.
Patients with epithelial ovarian, fallopian tube, and primary peritoneal cancers will be selected as the study population with Progression-Free Survival (PFS) as the primary study endpoint, and Overall Survival (OS), Duration Of Response (DOR), Quality of Life Score QoL, Chemotherapy-Free Interval (CFI), Progression-Free Survival 2 (PFS-2), CA125 response criteria by GCGI, to access the safety、Bone Mineral Density (BMD) changes and the tolerability of fluazoparib in combination with apatinib mesylate.
The study is planned to enroll 51 subjects, all of whom will receive study treatment after being signed informed and screened.
Eligibility criteria
Qualifiers
ECOG PS: 0-1;
Initially treated patients with histologically or cytologically confirmed high-grade plasma ovarian cancer (HGSOC), fallopian tube cancer, primary peritoneal cancer, or endometrioid carcinoma of the ovary with FIGO stage III-IV;
No prior maintenance therapy with PARP inhibitors; ④Final use of a combination chemotherapy regimen of bevacizumab, paclitaxel and carboplatin; ⑤Good function of major organs; ⑥Subjects voluntarily enrolled in this study, signed an informed consent form, had good compliance, and cooperated with follow-up visits; ⑦The modeled CA-125 ELIMination rate constant K (KELIM) ≥ 1.
Disqualifiers
Patients concurrently enrolled in other clinical trials;
Previous maintenance therapy with PARP inhibitors combined with anti-angiogenic drugs;
Previous history of allergic reaction, hypersensitivity reaction, intolerance to antibody-based drugs;
Previous significant allergy to drugs or food or other substances;
Trial design
Treatments tested in this trial
- Fluzoparib
- Apatinib Mesylate
Treatment groups
51 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov