Ovarian Cancer
Conditions
Interventions
Cohort 1:After 4 cycles of platinum-containing chemotherapy, the patient achieved complete clinical remission and began to take fluzopril.
Cohort 2:After 6 cycles of platinum-containing chemotherapy, the patient achieved complete clinical remission and began to take fluzopril.
Sponsors
Liaoning Provincial Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The patients voluntarily participated in this study and signed the informed consentincluding undergoing treatment and scheduled visits and examinations 2.Patients must be female 18-75 years of age 3.Newly diagnosed ovarian cancer, fallopian-tube cancer, or primary peritoneal cancer, that is stage III or IV according to International Federation of Gynecology and Obstetrics [FIGO] 4.Patients with histologically confirmed, high grade serous or high grade endometrioid ovarian cancer, fallopian-tube cancer or primary peritoneal cancer. 5.Satisfactory primary debulking surgeryno visible residual tumor or residual tumor=1cm(R0/R1) 6.After surgery, complete response ( CR ) was achieved after platinum-based chemotherapy, and screening should be completed within 8 weeks after the last dose of chemotherapy ; according to the RECIST1.1 standard, the disease was completely relieved ( CR ), and CA-125 was within the upper limit of normal ( ULN ) or not increased to 10 %. The researchers based on the patient 's condition. Patients must not be simultaneously enrolled in any clinical trial or any other investigational therapy during or after platinum-based chemotherapy 7.Should be able to provide formalin-fixed, paraffin-embedded ( FFPE ) tumor tissue specimens, submitted to the designated central laboratory, HRD test, and the test results were positive ; ( Equipment, Methods and Reagents : Based on 25000 SNP loci, HANDALE System database building technology and GIS algorithm were used to evaluate the status of homologous recombination defects in specimens, and to detect point mutations ( SNV ) and insertion deletion mutations ( indel ) in the coding region of the BRCA1 / BRCA2 gene and the exon-intron junction region ( 20bp ). The sample extraction and library building kits required for the experiment were provided by Ed, and sequencing can be performed on nextseq CN500) 8.Eastern Cooperative Oncology Group performance status 0–1 9.Patients must have a life expectancy =3 months 10.Patients must have normal organ function measured within screening test results defined as follows ·Hemoglobin = 90 g/L;Absolute neutrophil count = 1.5 × 109/ L; Platelets = 100 ×109/L(NO blood transfusion or products,no correction with G-CSF or other hematopoietic stimulating factors within 14 days before the first administration) ·Total bilirubin = 1.5 x ULN;ALT and AST =2.5 × ULN unless liver metastases are present in which case, they must be =5 × ULN ·Serum creatinine = 1.5 x ULN or calculated creatinine clearance = 60 mL/min using the Cockcroft-Gault equation 11.Non-lactating women 12.Female patients of non-surgical sterilization or childbearing age are required to use a medically approved contraceptive method after signing an informed consent form, during the study treatment period and within 8 weeks after the end of the study treatment period ; non-surgical sterilization of women of childbearing age in the study into the group within 72 h before the blood HCG test must be negative ; and must be non-lactation.
Exclusion criteria
Exclusion criteria: 1.Debulking surgery after neoadjuvant chemotherapy, or primary debulking surgery of residual tumor > 1cm 2.Any previous treatment with poly(adenosine diphosphate–ribose) polymerase 3.Inhibitor, including but not limited to olaparib, niraparib and rucaparib 4.Patinets who may receive other systemic anti-tumor therapy or plan to receive ovarian cancer cytoreductive surgery during the study 5.Patinets cannot swallow tablets normally, or have abnormal gastrointestinal function, which may affect drug absorption as judged by the investigator 6.Patients unable to provide sufficient tissue samples for hrd testing 7.Patients with central nervous system disease or brain metastases 8.Uncontrolled severe illnesses that the researchers believe affect the ability to receive treatment under the study protocol: such as severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer 9.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; 10.Patients must not have a known hypersensitivity to the components of research-related (fluzoparib) or the excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival Rate at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Progression Free Survival Rate at 24 months;Overall survival; | — |
Countries
China
Contacts
Public ContactWang Danbo
Liaoning Provincial Cancer Hospital
Outcome results
None listed