Ovarian Cancer
Conditions
Interventions
Experimental Group:Fluzoparib 100mg bid
Apatinib 250mg qd
4 weeks for a cycle
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined this study and signed an informed consent form; 2. Age = 18 years old (calculated based on the day of signing informed consent); 3. Pathologically diagnosed high-grade (or low-grade) serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 4. Previously, after undergoing 2-3 lines of platinum containing chemotherapy, the disease improved (CR or PR) after the last chemotherapy and continued until the study medication was administered. The trial medication began within 8 weeks of the last chemotherapy administration Preoperative neoadjuvant chemotherapy and postoperative chemotherapy are counted as one chemotherapy treatment regimen The last platinum containing chemotherapy should complete at least 4 cycles of treatment. After completing the platinum containing regimen, other anti-tumor drug treatments are not allowed; 5. ECOG score: 0-1; 6. Previously used PARPi maintenance therapy (specific requirement: the duration of initial PARPi exposure must be = 12 months after first-line chemotherapy or = 6 months after second-line chemotherapy); 7. The function of important organs meets the following requirements (no blood components or cell growth factors are allowed to be used within the first 14 days of randomization): absolute neutrophil count = 1.5 × 10^9/L; Platelets = 100 × 10^9/L; Hemoglobin = 10g/dL; Serum albumin = 3g/dL; Bilirubin = 1.5 times ULN; ALT and AST = 3 times ULN; Serum creatinine = 1.5 times ULN;
Exclusion criteria
Exclusion criteria: 1. Previous use of PARP inhibitors combined with anti angiogenic drugs for maintenance therapy 2. Previous (within 5 years) or concurrent incurable malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ and breast cancer with no recurrence>3 years after the completion of radical surgery; 3. Those who are unable to swallow medication normally, or have gastrointestinal dysfunction, which may affect drug absorption according to the researcher's judgment; 4. Those who have experienced intestinal obstruction recently (within 3 months); Accompanied by active ulcers, unhealed wounds, or fractures; 5. Urinary routine tests indicate that urine protein is =++and it has been confirmed that the 24-hour urine protein content is>1.0 g; 6. Patients with clinical symptoms of cancerous ascites or pleural effusion who require puncture or drainage, or those who have received ascites or pleural effusion drainage within 2 months before the first trial medication; 7. Clinical symptoms or diseases of the heart that cannot be well controlled; 8. Patients with abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds), bleeding tendencies, or undergoing thrombolytic or anticoagulant treatment are allowed to receive low-dose low-molecular-weight heparin or oral aspirin for prophylactic anticoagulant treatment during the trial period; 9. If there are significant clinically significant bleeding symptoms or clear bleeding tendencies within the first three months of randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, and if there is a positive fecal occult blood test during the baseline period, a follow-up examination can be conducted. If the test is still positive after the follow-up examination, combined with clinical judgment, a gastroscopy examination may be necessary; 10. Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment (systolic blood pressure = 140mmHg or diastolic blood pressure = 90mmHg); 11. Any bleeding event with a severe grade of 2 or higher in CTCAE 5.0 occurring within 4 weeks prior to the trial medication; 12. Subjects may receive other systemic anti-tumor treatments during the study period; 13. According to the researcher's judgment, there are other factors that may cause the study to be forced to terminate midway.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactMeiqin Zhang
Fudan University Shanghai Cancer Center
Outcome results
None listed