GBM
Conditions
Interventions
Intervention group:Fluzoparil combined with temozolomide
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years; 2. The ability of the subject to understand and be willing to sign the informed consent; 3. Be able to comply with the research visit schedule and other agreement requirements; 4. The patient must have prostate cancer confirmed by histology or cytology, which has been clinically determined as local according to imaging evaluation, According to the guidelines of the National Comprehensive Cancer Network (NCCN), it is divided into high risk and higher risk groups (the high risk group has no characteristics of extremely high risk group and has at least one of the following high risk characteristics: 1) The tumor stage was T3a, 2) graded into 4 or 5 groups, and 3) PSA>20 ng/mL; In the extremely high-risk group, there is at least one of the following: 1) The tumor stage is T3b-T4, 2) The main Gleason grade is 5, 3) There are 2 or 3 high-risk characteristics, 4) Patients with oligometastatic prostate cancer must have no visceral metastasis, and have=10 years; 7. Men who choose prostate cancer surgery as the main treatment for prostate cancer; 8. Willing to accept gene testing before and after surgery; 9. Normal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 50 mL/min.
Exclusion criteria
Exclusion criteria: 1. The second malignant tumor with activation; 2. Patients with neuroendocrine, small cell or sarcomatoid characteristics in prostate histopathology; 3. Previous experience includes PARP inhibitor treatment (such as olaparib, talazoparib, veliparib, niraparib, rubaparib or others), platinum chemotherapy (such as cisplatin, carboplatin, oxaliplatin or others), and mitoxantrone, cyclophosphamide, hormone deprivation therapy (luteinizing hormone releasing hormone [LHRH] agonist/antagonist), Anti-androgens (such as bicalutamide, nimide, enzalutamide, and apalumide) or new endocrine therapy (such as abiterone, enzalutamide, and Apalutamide); 4. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases, active or symptomatic viral hepatitis or chronic liver disease; 5. Clinically significant heart disease, such as myocardial infarction or arterial thrombosis in the past 6 months, severe or unstable angina pectoris; 6. Pre-existing duodenal stent and/or any gastrointestinal disease or defect that the researcher believes will interfere with drug absorption; 7. For any reason, the researcher believes that it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressive free survival, PFS;Objective remission rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event, AE;Overall survival, OS; | — |
Contacts
Public ContactTao Rongjie?Zhang Hui
Outcome results
None listed