Recurrent Ovary cancer
Conditions
Interventions
Experimental group:Sensitive drugs based on PDX scanning
Control group:platinum, paclitaxel
Sponsors
Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Provision of signed written informed consent; 2. Original diagnosis and/or histological confirmation of relapsed epithelial ovarian cancer; 3. Patients should have received optimal cytoreductive surgery with residual tumor <=1cm; histologically-confirmed epithelial ovarian; 4. Patient with recurrent platinum-resistant ovarian cancer at any stage; 5. Achieved a partial (PR) or complete (CR) tumor response following completion of the last platinum-containing chemotherapy [minimum of 4 cycles]; 6. Age = 18 years; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2; 8. Measurable disease as defined by Response Evaluation Criteria In Solid Tumours (RECIST) criteria version 1.1; January 2009 and/or evaluable disease (evaluable: cytologically or radiologically detectable disease such as ascites, peritoneal deposits, or lesions which do not fulfill RECIST criteria version 1.1 for measurable disease) [1,2];Participants for whom disease and response to therapy can be monitored by serum Cancer Antigen 125 (CA125) levels will also be eligible; 9. Adequate bone marrow function as defined by: White Blood Cells of = 1.5 x10^9/L, platelet count of = 80.0 x 10^9/L, and haemoglobin of = 9 g/dL; 10. Adequate liver function, as determined by: Serum total bilirubin =1.5 x Upper Limit of Normal [(ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) = 2.5 x ULN; 11. Adequate renal function assessed as glomerular filtration rate(GFR) = 60 mL/min using Cr51-ethylenediaminetetraacetic acid (EDTA) method and serum cr=1.25 x Upper Limit of Normal; 12. Ability to comply with protocol requirements; 13. Participants must be postmenopausal (12 months of amenorrhea), surgically sterile or they must agree to use a physical method of contraception. Oral or injectable contraceptive agents cannot be the sole method of contraception. Participants of child-bearing potential must have a negative serum pregnancy test within seven days prior to the first study drug administration.
Exclusion criteria
Exclusion criteria: 1. History of allergic reactions attributed to previous gemcitabine, platinum, paclitaxel, irinotecan, gemcitabine, Sola Fini treatment; 2. Previous treatment with Parp Inhibitor and with drugs targeted Braf; 3. Symptomatic Central Nervous System (CNS) or leptomeningeal metastases; 4. Another active cancer (excluding basal cell carcinoma) within the last 3 years; 5. Participants with uncontrolled concomitant illness or active infection requiring IV antibiotics; 6. Participants with serious illnesses, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with their participation in the study, or with the interpretation of the results; 7. Known Human Immunodeficiency Virus (HIV) or known active Hepatitis B or C; 8. Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc.) that, in the judgment of the investigator, may affect the participant's ability to sign the informed consent and undergo study procedures; 9. Currently pregnant, lactating or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactYaping Zhu
Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed