About this trial
This is an open-label, multi-center Phase II study of fluzoparib combined with bevacizumab for maintenance therapy after first-line platinum-containing chemotherapy in patients with BRCA wild-type advanced ovarian cancer. The primary objective is to evaluate median progression free survival of fluzoparib plus bevacizumab.
Eligibility criteria
Qualifiers
Signed informed consent and ability to comply with treatment and follow-up.
Age ≥ 18 years (Calculated on the date the informed consent was signed).
Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III or IV of the 2018 FIGO classification) ovarian, fallopian tube, or primary peritoneal cancer; and underwent tumor reduction surgery.
Patients must be prior to enrollment in complete response (CR) or partial response (PR) from their first line treatment, and use of the trial drug at least 3 weeks and no more than 9 weeks after their last dose of chemotherapy.
Disqualifiers
Previous (within 5 years) or concurrent with other uncured malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ and breast cancer with no recurrence >3 years after radical surgery;
Any previous treatment with PARP inhibitor, including, olaparib, niraparib, rucaparib, pamiparib, and fluzoparib;
Inability to swallow tablets properly or gastrointestinal function, may interfere with drug absorption, according to the investigator.
Recent (within 3 months) occurrence of intestinal obstruction, gastrointestinal perforation;
Trial design
Treatments tested in this trial
- Fluzoparib Capsules
- Bevacizumab