Ovarian Cancer
Conditions
Interventions
Intervention group:Senaparib plus Bevacizumab
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join this study, sign the informed consent form, have good compliance, cooperate with the follow-up Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with the follow-up; 2. Age 18~75 years old (calculated on the day of signing informed consent); 3. Patients with newly diagnosed and histopathologically confirmed epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer; 4. Stage IV and III subjects must have undergone one optimal debulking surgery (first cytoreductive surgery or intermittent cytodebulking). Phase IV study subjects must have had a biopsy and/or first cytoreductive surgery or intermittent cytoreductive; 10 pathological white tablets can be provided for follow-up research; 5. Tested as HRP; 6. CR or PR after receiving platinum-containing regimen; CR refers to measurable and/or non-measurable lesions assessed by imaging without RECIST v1.1 criteria and within the normal range of CA125. PR refers to the situation that after chemotherapy, the imaging evaluation achieves PR according to RECIST v1.1 criteria, or there are no measurable and/or non-measurable lesions according to RECIST v1.1 criteria, and CA125 is higher than the normal range and there must be no continuous elevation; 7. The test result of CA125 before treatment must meet the following specific criteria: • If the first test value = the upper limit of normal (ULN), the subject can be randomized without a second sampling; • If the first test value > ULN, a second assessment must be performed at least 7 days after the first test. If the second assessment value of the subject is >=15% higher than the first assessment value, the subject is not eligible for inclusion; 8. Must be enrolled and start the trial within 8~12 weeks from the last chemotherapy administration; 9. ECOG score: 0~1; 10. Normal function of major organs and meet the following requirements (no blood components and cell growth factors are allowed within 14 days before enrollment):( 1) Routine blood tests: hemoglobin (HB)>= 100g/L; Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelets (PLT)>=1×10^11/L (2) Blood biochemical tests: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =60 ml/min; (3) Coagulation function test: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) <=1.5× ULN; 11. Subjects of childbearing potential who need to use at least one medically approved contraceptive measure (such as intrauterine device or condom) during the study treatment period and within 6 months after the last administration of the study drug; And the serum HCG test result must be negative within 72 hours before the first dose; and must be non-lactating;
Exclusion criteria
Exclusion criteria: 1. Previous (within 5 years) or at the same time with other uncured malignant tumors, except for cured basal cell carcinoma of the skin, thyroid cancer, cervical carcinoma in situ and breast cancer without recurrence > 3 years after completion of radical resection; 2. No previous use of PARP inhibitors; 3. Unable to swallow tablets normally, or have abnormal gastrointestinal function, which may affect drug absorption as judged by the investigator; 4. Those who have a history of gastrointestinal perforation or have undergone major surgery within 4 weeks before the first dose; Patients with any bleeding or bleeding event >=CTCAE grade 3, or with unhealed wounds, ulcers, or fractures; 5. Imaging (CT or MRI) shows that the tumor invades large blood vessels or demarcates with blood vessels unclearly; 6. Patients with unsatisfactory blood pressure control (systolic blood pressure >=150 mmHg and/or diastolic blood pressure >=90mmHg); 7. Urine routine showed that urine protein >=2+, and confirmed 24-hour urine protein content >=1.0 g; 8. Those who have recently (within 3 months) intestinal obstruction; 9. Cancerous ascites or pleural effusion with clinical symptoms requiring puncture or drainage, or those who have received ascites or pleural effusion drainage within 2 months before the first trial drug; 10. Abnormal coagulation function (INR>1.5 or prothrombin time (PT) >ULN+4 seconds), with bleeding tendency or receiving thrombolytic or anticoagulant therapy, low-dose low-molecular weight heparin or oral aspirin prophylactic anticoagulation therapy is allowed during the trial; 11. Those who have used other drugs in clinical trials within the previous 4 weeks; 12. Received strong CYP3A4 inhibitors or strong inducers of CYP3A4 before the first dose of study drug (5 half-lives of eluting = the first dose of study drug can be enrolled), and strong CYP3A4 inhibitors or CYP3A4 strong inducers cannot be used during the study, refer to Appendix 4; 13. Subjects may receive other systemic anti-tumor therapy during the study; 14. Known allergy to senaparil and bevacizumab and its excipients; 15. According to the investigator's judgment, the subject has other factors that may lead to the forced termination of this study, such as other serious diseases (including mental illness) requiring combined treatment, serious laboratory test abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Countries
China
Contacts
Public ContactXingzhu Ju
Fudan University Shanghai Cancer Center
Outcome results
None listed