primary glioblastoma
Conditions
Interventions
Interventions group:Timozolomide is administered orally daily from day 1 to day 5, with 28 days as one cycle, for a total of 12 cycles. The initial dose for the first cycle is 150mg/m2/day. In subsequ
Sponsors
Affiliated Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined this study, signed an informed consent form, and had good compliance; 2. Age: 18-75 years old (at the time of signing the informed consent form); 3. Diagnosed by imaging or pathology as a high-grade glioma patient (glioblastoma, WHO grade IV, IDH wild-type); 4. The first study administration is 4-6 weeks after the last surgery (including biopsy, surgical resection, or other intracranial surgical procedures), and the researcher has determined that the surgical wound has healed well; Within 5 days before administration, the dosage of corticosteroids should be stable or gradually reduced; 6. The laboratory test results before enrollment meet the following criteria: (1) blood routine: platelet count = 75 × 109/L; Absolute neutrophil count = 1.5 × 109/L; Hemoglobin>90g/L. (2) Blood biochemistry: Aspartate aminotransferase (AST/SGOT) = 3 × ULN; Alanine aminotransferase (ALT/SGPT) = 3 × ULN; Total bilirubin = 2 × ULN; Serum creatinine = 1.5 × ULN; Urea nitrogen = 1.5 × ULN; Serum amylase = 1.5 × ULN or 1.5 × ULN<serum amylase = 2 × ULN but without evidence of pancreatic disease; Serum lipase = 1.5 × ULN or 1.5 × ULN<serum lipase = 2 × ULN but without evidence of pancreatic disease; Fasting serum triglyceride level = 2.5 × ULN. (3) Coagulation function: International normalized ratio of prothrombin time (INR) = 2.0; 7. KPS = 60 points, medication can be swallowed and maintained for oral administration; 8. Expected survival period = 3 months; 9. Women of childbearing age must undergo a pregnancy test with a negative result within 7 days prior to the first dose, and commit to using at least one acceptable contraceptive measure (i.e. intrauterine device, barrier method containing spermicide, condom, any form of hormonal contraceptive, or abstinence) throughout the study period and for 6 months after the last study treatment;
Exclusion criteria
Exclusion criteria: 1. Patients who need to use other chemotherapy drugs simultaneously during the study period; 2. Patients with epileptic seizures that cannot be effectively controlled by medication; 3. Patients who have previously received treatment with sustained-release Camustine implants or radiation therapy for brain lesions; 4. Patients with active bleeding detected by cranial CT or MRI scan before enrollment; 5. Difficult to control hypertension, with systolic blood pressure>150 mmHg and/or diastolic blood pressure>100 mmHg after treatment with antihypertensive drugs; 6. Within the first 3 months of enrollment, there were cases of decompensated heart failure (NYHA grades III and IV), unstable angina, acute myocardial infarction, and persistent and clinically significant arrhythmias; 7. Suffering from gastrointestinal diseases that affect gastrointestinal absorption and digestion function, such as a history of gastrointestinal resection surgery, intestinal obstruction, gastrointestinal bleeding in the past 3 months before enrollment, or severe diarrhea; 8. Those who have previously used anti-tumor angiogenesis drugs; 9. It is uncertain which patients will not receive electric field therapy; 10. Patients with active infections or requiring long-term oxygen therapy during the screening period; 11. Drug abuse or drug addiction; 12. Patients who test positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV); 13. Pregnant women, breastfeeding women, or patients with recent fertility plans; 14. Patients who have participated in drug clinical trials within the past 3 months prior to enrollment; 15. According to the researchers' assessment, there may be other factors that could lead to the forced termination of this study, such as other serious illnesses (including mental illnesses) requiring concurrent treatment, serious laboratory abnormalities, and family or social factors that could affect the safety of the subjects or the collection of data and samples.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Objective relief rate;Overall survival period;security;Quality of life score;Disease control rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression free survival period; | — |
Countries
China
Contacts
Public Contacthui zhang
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed