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.
During the treatment period, subjects were given fluazoparib capsules orally, two capsules/dose (50mg/capsule) twice daily, taken orally in the morning and in the evening, as a continuous dosage. Subjects will also receive oral apatinib mesylate tablets, one tablet/dose (250 mg/tablet), once daily, continuously. Treatment will continue until an event occurs that meets the criteria for discontinuation of treatment. Safety evaluations will be performed on Day 1 of each 3-week treatment cycle (vital signs, physical examination, laboratory examination, physical status score and BMD testing); imaging evaluations and once CA125 test will be performed every 6 weeks for the first 24 weeks of dosing, and every 9 weeks thereafter to assess efficacy, and for 12 months or until an event occurs that meets the criteria for treatment discontinuation. Dose suspension or downward adjustment may be made during the study period based on the occurrence of adverse events in subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
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.
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.
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
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
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
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
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
AE
Adverse events (AE) are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.
Time frame: 2 year
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