Glioma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1: Aged between 18 and 65 years, regardless of gender 2: Diagnosed with malignant glioma, with pathological types including anaplastic astrocytoma or glioblastoma, clinical staging of high-grade glioma (Grade III–IV) or high-risk low-grade glioma (Grade I–II). High-risk factors include astrocytoma, age >40 years, Karnofsky Performance Status (KPS) 6 cm, tumor crossing the midline, moderate to severe preoperative neurological deficits, and tumor location in the temporal, parietal, occipital, or frontal lobes 3: Treatment regimen involving radiotherapy combined with concurrent adjuvant temozolomide chemotherapy 4: Postoperative clinical diagnosis of manic episode or psychiatric symptoms 5: Karnofsky Performance Status (KPS) >60 6: No missing key data, defined as indicators that affect study execution and outcome evaluation, including gender, pathological type, age, tumor location, clinical stage, treatment information, Mini-Mental State Examination (MMSE), cranial MRI imaging, progression-free survival (PFS), and overall survival (OS) 7: Voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: 1: Patients who received radiotherapy, chemotherapy, or other antitumor drug treatments prior to surgery 2: Patients with digestive or hematologic diseases within the past 6 months, or those with decreased blood cell counts and neutropenia due to any cause, as well as patients who have undergone bone marrow transplantation 3: Patients allergic to alkylating agents such as temozolomide 4: Pregnant or lactating patients 5: Patients with severe renal or hepatic impairment 6: Patients with cardiovascular or cerebrovascular diseases prone to hypotension, epilepsy, prostatic hyperplasia, or paralytic ileus 7: Patients who drive vehicles or operate machinery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Peking University Shenzhen Hospital