Glioblastoma
Conditions
Interventions
100 µg group:Injection of 100 µg cancer vaccine.
150 µg group:Injection of 150 µg cancer vaccine.
200 µg group:Injection of 200 µg cancer vaccine.
Sponsors
Beijing Neurosurgical Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient must voluntarily sign the informed consent form and demonstrate good compliance during follow-up; 2. Age >=18 years, both male and female participants are eligible; 3. Supratentorial IDH-wildtype glioblastoma located in the frontal, temporal, or occipital lobe with EGFR gene mutation; complete tumor resection confirmed by imaging within 10 days after initial surgery, followed by standard radiotherapy and/or chemotherapy; no tumor recurrence observed on MRI at 4 months postoperatively; 4. Karnofsky Performance Status (KPS) score >=60 before treatment; 5. Normal immune function, bone marrow reserve, and normal liver and kidney function: absolute neutrophil count >=1,500/mm³; hemoglobin >=10 g/dL; platelet count >=100,000/mm³; total bilirubin <=1.5 × ULN; ALT/AST <=2.5 × ULN; serum creatinine <=1.5 × ULN; normal cardiac function; 6. Women of childbearing age (15–49 years) must have a negative pregnancy test within 7 days prior to the start of treatment; male and female patients of reproductive potential must agree to use effective contraception during the study period and for 6 months after treatment.
Exclusion criteria
Exclusion criteria: 1. Unwilling or unable to undergo treatment and follow-up assessments; 2. History of brachial neuritis or Guillain-Barré syndrome; 3. History of organ transplantation or currently awaiting organ transplantation; 4. Uncontrolled infectious diseases or other serious conditions, such as HIV, or seropositivity for hepatitis B or hepatitis C; 5. Any unstable systemic disease, including but not limited to: active infections, uncontrolled hypertension, unstable angina, newly onset angina within the past 3 months, congestive heart failure, myocardial infarction within 12 months prior to enrollment, severe arrhythmias requiring medical treatment, liver or renal failure; 6. Patients with systemic autoimmune diseases or immunodeficiency disorders; 7. Patients with a history of severe allergies; 8. Patients with chronic diseases requiring long-term treatment with immunosuppressants or corticosteroids; 9. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events;Laboratory Tests;Electrocardiogram;Echocardiography;Vital Signs;Physical Examination;Antigen-specific T cell responses in peripheral blood; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progression-Free Survival; | — |
Countries
China
Contacts
Public ContactFusheng Liu
Beijing Neurosurgical Institute
Outcome results
None listed