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.
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.
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;
Single group
Fluzoparib Capsules
Drugoral
Bevacizumab
DrugInjectable solution
Progression-free Survival (PFS)
Time from the date of first study treatment administration to the date of first documented tumor progression or death due to any cause, whichever occurs first.
Overall survival (OS)
Time from the date of first study treatment administration to the date of death due to any cause.
Objective Response Rate (ORR)
ORR is the proportion of patients with best response of complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time to start of first subsequent therapy or death (TFST)
TFST is defined as the time from the first study administration to the earliest of the date of anti-cancer therapy start date following study treatment discontinuation, or death.
Time to start of second subsequent therapy or death (TSST)
TSST is defined as the time from the first study administration to the earliest of the date of second subsequent anti-cancer therapy start date following study treatment discontinuation, or death.
Exploratory endpoint
Open collection of homologous recombination deficiency status (HRD) status was performed to assess the impact of HRD status on the efficacy of fluazoparib in combination with bevacizumab.
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This trial is not recruiting at the moment. You can still explore other options:
