Ovarian cancer
Conditions
Interventions
Group 1:Bevacizumab combined with Fluzoparib
Group 2:Bevacizumab combined with chemotherapy
Group 3:Fluzoparib monotherapy
Sponsors
The Second Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, female; 2. Recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer proven to be platinum-resistant by histology or cytology; 3. ECOG score 0-1; 4. Expected survival time > 12 weeks; 5. Normal or abnormal bone marrow, kidney, and liver function of the patient has no clinical significance, and the specific situation will be comprehensively determined by the investigator; 6. Patients not previously treated with PARPi or targeted drugs; 7. The patient has taken effective contraceptive measures within 14 days before screening, and is willing to have no pregnancy plan and voluntarily take effective contraceptive measures from the time of signing the informed consent to 6 months after the last dose; 8. The subject or his/her legal guardian can communicate well with the investigator, understand and comply with the requirements of this study, and understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Known allergy to fluzopalil or study drug components; 2. Patients with any factors affecting oral administration (such as previous gastric or small bowel resection, or current atrophic gastritis, chronic intestinal disease, gastrointestinal bleeding, dysphagia, gastrointestinal obstruction, or diarrhea greater than grade 1, including those who have recovered but have not recovered); 3. Patients who underwent major surgery or gastrointestinal surgery affecting drug absorption, open biopsy, severe traumatic injury, wound unhealed or did not recover from major surgery within 1 month before the trial; 4. Before the first administration, patients have used strong CYP3A inhibitors (such as itraconazole, telithromycin, clarithromycin, ritonavir, etc.) or medium CYP3A inhibitors (such as ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil, etc.); patients who had used strong CYP3A inducers (e.g., phenobarbide, enzyluamide, phenytoin, rifampicin, rifambutin, rifapentine, carbamazepine, nevirapine and St. John's herb) or medium CYP3A inducers (e.g., Bosentan, efavirenz, modafinil, etc.) and did not reach 3 elimination half-lives; 5. Pregnant or lactating women or subjects who cannot use contraception as required; 6. Those who have special requirements on diet and cannot accept uniform diet; 7. As judged by the researcher, there are other circumstances that are not suitable for the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;Overall Survival;Adverse event; | — |
Countries
China
Contacts
Public ContactLiu Haiyan
The Second Affiliated Hospital of Shandong First Medical University
Outcome results
None listed