Glioblastoma
Conditions
Interventions
Niraparib + Radiotherapy:Niraparib 200mg QD
Sponsors
Tianjin Huanhu Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The subjects who signed the written informed consent before conducting any research related procedures; 2. Male or female aged between 18 and 70 years; 3. Patients with histologically confirmed WHO grade IV recurrent glioblastoma; 4. Patients with an expected survival period of more than 6 months; 5. Patients who can receive radiotherapy again; 6. Patients with KPS >= 60; 7. Patients who can swallow and maintain oral medication; 8. In the past month, patients with major seizures less than 3 times a week; 9. Good organ function, including: (1) Bone marrow function: neutrophil count >= 1500 / µ L; platelet count >= 100000 / µ L; hemoglobin count >= 10g / dl; (2) Liver function: total bilirubin = 60ml / min (calculated according to Cockcroft Gault formula); 10. Patients with the ability to comply with the protocol; 11. Patients whose toxicity of previous chemotherapy has returned to <= CTCAE 1 or baseline, except for stable sensory neuropathy or alopecia <= CTCAE 2.
Exclusion criteria
Exclusion criteria: 1. Subjects known to be allergic to active or inactive components of nilaparil or drugs with similar chemical structure to nilaparil; 2. Patients who have been treated with PARP inhibitors in the past; 3. Patients who had undergone major surgery within 3 weeks before the start of the study, or those who had not recovered from surgery or received chemotherapy; 4. Patients who received palliative radiotherapy with more than 20% bone marrow one week before enrollment; 5. The patient has myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) previously or currently diagnosed; 6. Patients with severe or uncontrolled diseases, including but not limited to: (1) Uncontrollable nausea and vomiting, inability to swallow the study drug, any gastrointestinal disease that may interfere with drug absorption and metabolism; (2) Active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C, etc; (3) Uncontrolled ventricular arrhythmia, myocardial infarction in the last 3 months, uncontrolled epileptic seizure, unstable spinal cord compression, superior vena cava syndrome or other mental disorders that affect the informed consent of the patient; (4) Immune deficiency (except splenectomy) or other diseases that researchers believe may expose patients to high-risk toxicity; (5) Hypertension that cannot be controlled by drugs; (6) As well as any cause of intracranial hypertension, intracranial hemorrhage, intracranial infarction performance; 7. Patients with distant metastasis; 8. Any previous or current disease, treatment, or laboratory abnormality that may interfere with the results of the study and affect the full participation of the patient in the study, or the researcher thinks that the patient is not suitable to participate in the study; the patient is not allowed to receive platelet or red blood cell infusion within four weeks before the start of treatment of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS6; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events;Quality of life; | — |
Countries
China
Contacts
Public ContactWei Jiang
Tianjin Huanhu Hospital
Outcome results
None listed