Fluzoparib and Apatinib Versus Fluzoparib in Relapsed Ovarian Carcinoma Maintenance Treatment
ConditionRelapsed Ovarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorXiaohua Wu MD
About this trial
This study is a Phase II randomized, open label, controlled, multicenter study to access the effects and tolerability of fluzoparib combined with apatinib versus fluzoparib monotherapy for maintenance treatment in platinum-sensitive relapsed ovarian carcinoma (including patients previous treated with a PARP inhibitor).
Eligibility criteria
Qualifiers
The patient voluntarily joined the study and signed the informed consent
Patients ≥18 years of age.
Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; ≥grade II ovarian endometrioid adenocarcinoma.
Mixed mullerian: contain high-grade serous component or endometrioid components over 50%.
Disqualifiers
Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix or breast cancer without recurrence over 3 years allowed.
Untreated and/or uncontrolled brain metastases.
Not able to swallow pills normally, or have abnormal gastrointestinal function affecting drug absorption as judged by the researcher.
Intestinal obstruction within 3 months.
Trial design
Treatments tested in this trial
- Fluzoparib+Apatinib
- Fluzoparib Monotherapy
Treatment groups
132 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Xiaohua Wu MD
Lead sponsor
Fudan University
Sponsor institution
Source ClinicalTrials.gov