Ovarian cancer
Conditions
Interventions
experimental group:Fluzopalil capsules
control group:Fluzopalil placebo simulation capsule
Sponsors
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily joins the study and signs the informed consent; 2. Female, aged between 18 and 75 (calculated on the date of signing informed consent); 3. High-grade (or poorly differentiated) serous ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by pathology; or high grade (or poorly differentiated) ovarian endometrioid adenocarcinoma by pathology; 4. Platinum-sensitive first recurrence of ovarian cancer; 5. Previous use of PARPi maintenance therapy =18 months; 6. After or without secondary cytoreductive surgery; 7. After the treatment of platinum-containing regimen, the efficacy was evaluated as complete remission (CR) or partial remission (PR); CR definition: imaging evaluation without lesions, and CA125 within the upper limit of normal value (=ULN); PR definition: residual lesions after tumor cytoreductive surgery are reduced by more than 30% after chemotherapy; Or when there was no lesion in imaging evaluation after treatment, CA125 did not decrease to the upper limit of normal value (=ULN), but decreased =90% during the course of chemotherapy. Or, if there is no measurable lesion, CA125 must be reduced to the upper limit of normal (ULN) or decreased by =90% during the course of first-line chemotherapy; 8. Maintenance with bevacizumab is not allowed after completion of chemotherapy, but patients who have received bevacizumab in platinum-containing chemotherapy but are not suitable for bevacizumab as maintenance therapy can be considered in the group; 9. During or after chemotherapy in platinum-containing regimen, other clinical research drugs and anti-tumor drugs (except endocrine therapy drugs and Traditional Chinese medicine and modern Chinese medicine preparations) are not allowed to be used at the same time; 10. Two CA125 tests should be completed during the screening period, and the interval between the two CA125 tests should be =7d. If CA125>ULN is detected for the first time and CA125 increases by more than 10% compared with the previous test, the patients cannot be included in the group; 11. Must be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue samples to the designated central laboratory for biomarker testing; 12. ECOG score: 0 ~ 1; 13. The function of vital organs meets the following requirements (no use of blood components and cell growth factors within the first 14 days of randomization is allowed) : 1)Platelet =100×109/L; 2)Hemoglobin =10g/dL; 3)Serum albumin =3g/dL; 4)Bilirubin =1.5 times ULN; 5)ALT and AST =3 times ULN; 6)Serum creatinine =1.5 times ULN; 14. Patients with potential fertility need to use at least one medically approved contraceptive method (such as an intrauterine device or condom) during the study period and for 3 months after the study period; Serum HCG test must be negative within 72 hours prior to study randomization. It must be a non-lactation period.
Exclusion criteria
Exclusion criteria: 1. Subjects have previous (within 5 years) or concurrent malignancy, except cured basal cell carcinoma of skin, carcinoma in situ of cervix and breast cancer without recurrence for more than 3 years after radical resection; 2. People with untreated transfer of central nervous system, always received systemic, radical brain or meningeal metastasis treatment (radiation therapy or surgery), such as stable imaging has to maintain at least a month, and have stopped systemic sex hormone therapy (> 10 mg/day dose effect of hormones such as prednisone or other) greater than 2 weeks, no clinical syndrome of patients can be incorporated into; 3. Patients with intestinal obstruction or gastrointestinal perforation within the previous 3 months; 4. Those who cannot swallow pills normally, or have abnormal gastrointestinal function, which may affect drug absorption as judged by the researcher; 5. Clinical symptoms or diseases of the heart that are not well controlled, such as NYHA grade 2 or above heart failure; Unstable angina pectoris; Myocardial infarction occurred within 1 year; Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; QTc > 470 ms; 6. Patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg); 7. Any bleeding event with severity grade 2 or above in CTCAE 5.0 occurred within 4 weeks before randomization; 8. Previous or current interstitial pneumonia, drug-induced pneumonia, or active pneumonia during screening; 9. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds), with bleeding tendency; Or are receiving thrombolytic or anticoagulant therapy, are allowed to receive low-dose low-molecular weight heparin or oral aspirin prophylaxis anticoagulant therapy; 10. 6 months prior to random dynamic/enous thromboembolism event occurred, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, in view of the lower limb muscle between vein thrombosis without anticoagulation therapy, by way of assessment of mural thrombus has disappeared as a result of catheter and does not need medication, can consider into the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DoR;DCR;RR; | — |
Countries
China
Contacts
Public ContactDi Wen
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed