Epithelial ovarian cancer
Conditions
Interventions
PARP inhibitor group:Oral fluzoparib capsules
Sponsors
Shanghai First Maternity and Infant Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up; 2. Age >= 18 years old (calculated on the day of signing the informed consent); 3. High-grade (or poorly differentiated) serous ovarian cancer, fallopian tube cancer or primary peritoneal cancer diagnosed by pathology. Mixed tumors: high-grade serous type or endometrioid components >= II must be > 50%. 4. Platinum-containing regimen treatment after tumor reduction surgery, 2 or more platinum-containing regimens in the past, and the last chemotherapy was platinum-containing regimen chemotherapy: 5. Neoadjuvant chemotherapy before surgery and chemotherapy after surgery are counted as one chemotherapy treatment plan. 6. The time from the penultimate platinum-containing treatment to the end of treatment (last platinum treatment) to biochemical recurrence/progression>6 months (184 days); definition of biochemical recurrence: CA-125 > 2 x upper limit of normal; definition of clinical recurrence/progress : There is clear imaging or clinical evidence that the disease has recurred or progressed earlier. 7. Remission of disease during the last platinum treatment (CR): The last platinum treatment must be a platinum-based chemotherapy regimen, and bevacizumab cannot be used in combination or alone before the last treatment is randomized; The last platinum-containing chemotherapy has completed at least 4 cycles of treatment. After the platinum-containing regimen is completed, no other treatments other than endocrine therapy drugs are allowed; during the last platinum-containing regimen, the therapeutic effect of imaging evaluation is CR, CA125 in treatment The period is reduced to within the upper limit of the normal value. 8. ECOG score: 01; The functions of vital organs meet the following requirements (no blood components and cell growth factors are allowed to be used within 14 days before randomization): Absolute neutrophil count >= 1.5 x 10^9/L; Platelets >= 90 x 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; 9. Patients with potential for childbirth, need to use a medically approved contraceptive method (such as intrauterine device, contraceptive or condom) during the study treatment period and within 3 months after the end of the study treatment period; and must be in the study The serum HCG test within 72 hours before enrollment must be negative; and it must be a non-lactating period.
Exclusion criteria
Exclusion criteria: 1. Past (within 5 years) or other uncured malignant tumors at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and breast cancer that has not recurred more than 3 years after the completion of radical resection; 2. The subject has used PARP inhibitors in the past, including but not limited to olaparib, niraparib and lukapanib; 3. The subject has untreated central nervous system metastasis, Have received systemic and radical brain or meningeal metastasis therapy (radiotherapy or surgery) in the past, if imaging confirmed that the stability has been maintained for at least 1 month, and systemic hormone therapy has been stopped (dose>10mg/day prednisone or other curative effects Hormone) patients who are more than 2 weeks old and have no clinical symptoms can be included; 4. Can not swallow pills normally, or have abnormal gastrointestinal function, which may affect drug absorption by the researcher's judgment; 5. Intestinal obstruction occurred recently (within 3 months); 6. Those who have clinical symptoms of cancerous ascites or pleural effusion who need puncture or drainage, or those who have received ascites or pleural effusion drainage within 2 months before the first trial medication; 7. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) Heart failure above NYHA level 2 (2) Unstable angina (3) Myocardial infarction occurred within 1 year (4) Clinically significant supraventricular or Ventricular arrhythmia needs treatment or intervention (5) QTc > 470ms; 8. Abnormal coagulation function (INR>1.5 or prothrombin time (PT) > ULN+4 seconds), bleeding tendency or undergoing thrombolysis or anticoagulation therapy, allowed to receive low-dose low molecular heparin or oral aspirin during the trial period Anticoagulant therapy; 9. The subject has active infection or fever of unknown cause occurred during the screening period and before the first dose of >38.5 degrees; 10. The subject has congenital or acquired immune function defects (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> normal value Upper limit); Those who have previously received radiotherapy, chemotherapy, hormone therapy, or molecular targeted therapy, after the completion of the treatment (last medication), less than 4 weeks before the study medication (for oral molecular targeted drugs less than 5 drug half-lives); caused by previous treatment The adverse events (except for hair loss) have not recovered to <= 1 degree (CTCAE 5.0); Persons who have used other drugs in clinical trials within 4 weeks before randomization; subjects may receive other systemic anti-tumor treatments during the study period; 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 illness) that require combined treatment, severe laboratory abnormalities, and family or social factors. , It will affect the safety of subjects or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum CA-125 level;Time to disease progression evaluated based on GCIG-CA125 evaluation standard (TTP);Chemotherapy-free interval;Tumor score based on RECIST v1.1; | — |
Countries
China
Contacts
Public ContactXiaoqing Guo
Shanghai First Maternity and Infant Hospital
Outcome results
None listed