Recurrent glioblastoma
Conditions
Interventions
Interventions group:Temozolomide was administered on days 1-7 and 15-21 at a dose of 125 mg/m2, with each 4-week period constituting one cycle. Bevacizumab and Thiotepa were administered intravenously
Sponsors
Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily joined this study, signed the informed consent form, and demonstrated good compliance;2. Age: 18-75 years old (at the time of signing the informed consent);3. Diagnosed by imaging or pathology as recurrent glioblastoma patients (glioblastoma, WHO grade IV), and according to RANO criteria, there is at least one measurable lesion;4. In the 5 days before administration, corticosteroid dosage was stable or gradually reduced;5. Laboratory test results before enrollment meet the following criteria: (1) Complete blood count: platelet count >=75×10^9/L; absolute neutrophil count >=1.5×10^9/L; hemoglobin >90g/L; (2) Blood biochemistry: aspartate aminotransferase (AST/SGOT) =70, able to swallow medication and maintain oral administration;7. Expected survival >=3 months;8. Women of childbearing potential must have a negative pregnancy test within 7 days before the first administration and commit to using at least one acceptable contraceptive method throughout the study period and for 6 months after the last study treatment (i.e., use an intrauterine device, spermicidal barrier method, condom, any form of hormonal contraceptive, or abstinence).
Exclusion criteria
Exclusion criteria: 1. Patients requiring concomitant use of other chemotherapeutic agents during the study period; 2. Patients with grand mal seizures that cannot be effectively controlled by medication; 3. Patients with prior history of treatment with carmustine sustained-release implant or intracranial radiation therapy; 4. Patients with active haemorrhage detected by cranial CT or MRI scan prior to enrolment; 5. Patients with uncontrolled hypertension, where systolic blood pressure remains >150 mmHg and/or diastolic blood pressure >100 mmHg despite antihypertensive therapy; 6. Patients who have experienced decompensated heart failure (NYHA Class III or IV), unstable angina, acute myocardial infarction, or persistent clinically significant arrhythmias within 3 months prior to enrolment; 7. Gastrointestinal disorders affecting absorption or digestive function, such as history of gastrointestinal resection, intestinal obstruction, gastrointestinal bleeding within 3 months prior to enrolment, or severe diarrhoea; 8. Patients for whom it cannot be confirmed that they will not undergo electric field therapy; 9. Patients with active infection or requiring long-term oxygen therapy during the screening period; 10. Individuals with substance abuse or drug dependency; 11. Patients testing positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV); 12. Pregnant or breastfeeding women, or those with recent plans for pregnancy; 13. Other factors deemed by the investigator likely to necessitate premature termination of study participation, such as concomitant treatment for other serious illnesses (including psychiatric conditions), severe laboratory abnormalities, or familial/social circumstances compromising participant safety or data/sample collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median Progression free survival period;Three-month disease-free survival rate;6-month disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Quality Of Life Assessment;AE / SAE; | — |
Countries
China
Contacts
Public ContactZhang hui
Cancer Hospital of Shandong First Medical University
Outcome results
None listed