glioma
Conditions
Interventions
Test group:fluzoparib
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: = 18 years old, = 70 years old, male or female; 2. Recurrent high-grade glioma confirmed by imaging or pathology (WHO grade 3~4) with measurable lesions (MRI enhanced scan=10mm, meeting RECIST 1.1 criteria) 3. ECOG PS: 0-2 points; 4. The subject's baseline blood routine and biochemical indexes meet the following standards: Hemoglobin = 80g/L, white blood cell =2×109/L absolute neutrophil count (ANC) =1.0×109/L, platelet = 50×109/L, ALT, AST =2.5 times the upper limit of normal, =5 times the upper limit of normal (with liver metastases), serum total bilirubin = 1.5 times the upper limit of normal, serum creatinine = 1.5 times the upper limit of normal, serum albumin = 30g/L; 5. Estimated survival= 3 months; 76 Signed informed consent form (ICF) prior to study selection; Women of childbearing age must have a pregnancy test (serum or urine) within 7 days prior to enrollment, have a negative result, and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, surgical sterilization should be given, or consent to appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug.
Exclusion criteria
Exclusion criteria: 1. Those who have been confirmed to be allergic to fluzoparib and/or its excipients; 2. Patients with tertiary and above myelosuppression (peripheral hemoglobin 140 mmHg, diastolic blood pressure >90 mmHg), with grade I coronary heart disease or above, grade I arrhythmias (including QTc interval prolongation > 450 ms for men and >470 ms for women) and grade I cardiac insufficiency; Patients with positive urine protein; 4. Patients with a clear tendency to local bleeding of tumors; 5. Abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency; 6. Have a variety of factors affecting oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 7. Pregnant or lactating women; 8. Other malignant tumors within 5 years; 9. Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders; 10. Participated in clinical trials of other drugs within four weeks; 11. Those who have received PARP inhibitors, such as olaparib, veraparib treatment; 12. According to the judgment of the investigator, there are serious concomitant diseases that endanger the safety of the patient or affect the patient's completion of the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Objective remission rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;adverse event;Serious adverse events; | — |
Countries
China
Contacts
Public ContactJiang Xin
The First Hospital of Jilin University
Outcome results
None listed