Ovarian cancer
Conditions
Interventions
Experimental group:Fluzopari combined with apatinib
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily participated in this study and signed the informed consent; 2. Aged >= 18 years; 3. High-grade serous ovarian, fallopian tube, primary peritoneal cancer; >= grade 2 ovarian endometrioid carcinoma; 4. Patients have received parpi maintenance treatment in the first line,the second line with platinum-containing chemotherapy achieved CR/PR; 5. BRCA+/-,all is permissible; 6. ECOG score 0-1 points; 7. The functions of vital organs meet the following requirements (no blood components and cell growth factors were used to correct the treatment within 14 days before the first administration): (1) Absolute neutrophil count >= 1.5x10^9/L; (2) Platelets >= 100x10^9/L; (3) Hemoglobin >= 100 g/L; (4) Serum albumin >= 30 g/L; (5) Bilirubin <= 1.5xULN (within 7 days before first dose); (6) ALT and AST <= 3xULN (within 7 days before first dose); (7) Serum creatinine <=1.25xULN; 8. Non-surgical sterilization or female patients of childbearing age need to use two medically approved contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study treatment period and within 3 months after the end of the study treatment period; non-surgical sterilized female patients of childbearing age must have a negative serum HCG test within 72 hours before the first dose, and must be non-lactating; for male patients whose partners are women of childbearing age, two effective methods of contraception should be used during the study treatment period and for 3 months after the end of the study treatment period.
Exclusion criteria
Exclusion criteria: 1. Suffering from other uncured malignant tumors in the past (within 5 years) or at the same time, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and breast cancer with no recurrence > 3 years after radical resection; 2. The subject has previously used PARP inhibitors, including but not limited to olaparib, niraparib and rucaparib; 3. The subject has untreated central nervous system metastases and has previously received systemic, radical brain or meningeal metastases (radiotherapy or surgery), subjects who have been stable for at least 1 month and have stopped systemic hormone therapy (dose >10mg/day prednisone or other equivalent efficacy hormones) for more than 2 weeks and no clinical symptoms can be included if confirmed by imaging studies; 4. Those who cannot swallow tablets normally, or have abnormal gastrointestinal function, which may affect drug absorption as judged by the investigator; 5. Those who have experienced intestinal obstruction recently (within 3 months); 6. Cancerous ascites and pleural effusion with clinical symptoms, those who need puncture and drainage, or who have received ascites or pleural effusion drainage within 2 months before the first trial drug; 7. There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) NYHA grade 2 or higher heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) QTc>470ms; 8. Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds), those who have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, prophylactic anticoagulation therapy with low-dose low-molecular-weight heparin or oral aspirin is allowed during the trial; 9. The subject has active infection or unexplained fever >38.5 degrees during the screening period and before the first dose; 10. Subjects with congenital or acquired immunodeficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive, HBV DNA >= 500 IU/ml; hepatitis C reference: HCV antibody positive, HCV virus copy number> upper limit of normal value); 11. Those who have previously received radiotherapy, chemotherapy, hormone therapy, or molecular targeted therapy, after the completion of the treatment (the last drug), and less than 4 weeks before the study drug (oral molecular targeted drug is less than 5 drug half-lives); adverse events (except alopecia) caused by previous treatment that have not recovered to <=1 degree (CTCAE 5.0); 12. The subjects may receive other systemic anti-tumor therapy during the study; 13. According to the judgment of the investigator, the subject has other factors that may cause the study to be terminated halfway, such as other serious diseases (including mental diseases) that require combined treatment, serious laboratory abnormalities, and family or social conditions. and other factors, which will affect the safety of subjects, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Chemotherapy free intervals;Duration of response;Overall Survival; | — |
Countries
China
Contacts
Public ContactWang Jinhua
Jiangsu Cancer Hospital
Outcome results
None listed