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Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer

ConditionsEpithelial Ovarian CancerEfficacySafetyBone Mineral DensityTolerability
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Fluzoparib

    Drug

    The study treatment was followed by a 3-week treatment cycle. First day of each dosing cycle, subjects are required to complete various examinations, including vital signs, physical examination, laboratory examination, physical status score, and BMD testing to evaluate the safety and tolerability of continued treatment.

  • Apatinib Mesylate

    Drug

    The study treatment was followed by a 3-week treatment cycle. First day of each dosing cycle, subjects are also required to complete various examinations, including vital signs, physical examination, laboratory examination, physical status score, and BMD testing to evaluate the safety and tolerability of continued treatment.

Treatment groups

51 Participants
are divided into 2 treatment groups
Group A: Fluzoparib groupExperimental treatment 1 intervention
Group B: Apatinib Mesylate groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS

Progression-Free Survival (PFS) is defined as the time interval between a patient's diagnosis of gynecological malignancy and the first occurrence of progression of the disease or death from any cause.

Time frame
2 year

Secondary outcomes

1

OS

Overall Survival (OS) was defined as the time interval between a patient's diagnosis of gynecologic malignancy and death from any cause or the end of the last follow-up date.

Time frame
2 year
2

DOR

Duration Of Response (DOR) is defined as the time from when a patient reaches first remission (including complete or partial remission) to when the disease re-progresses.

Time frame
2 year
3

QoL

Quality of Life Score (QoL) is a score that assesses a patient's overall physical, psychological, social, and environmental well-being through a standardized questionnaire or scale.The scale has a full score of 60, with a very poor score of \<20, a poor score of 21-30, a fair score of 31-40, a better score of 41-50, and a good score of 51-60.

Time frame
2 year
4

PFS-2

Progression-Free Survival 2 (PFS-2) defined as the time from patient randomization to completion of secondary therapy after disease re-progression or patient death.

Time frame
2 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anhui Provincial Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: