Clinical Study on the Safety and Immunogenicity of Specific Cancer Vaccines in Preventing Recurrence of Glioblastoma

Korábbi kezelés

• 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.
• Patients with chronic diseases requiring long-term treatment with immunosuppressants or corticosteroids.

Más betegség

• History of brachial neuritis or Guillain-Barré syndrome.
• History of organ transplantation or currently awaiting organ transplantation;
• Uncontrolled infectious diseases or other serious conditions, such as HIV, or seropositivity for hepatitis B or hepatitis C.
• Patients with systemic autoimmune diseases or immunodeficiency disorders.
• Patients with a history of severe allergies.

Egyéb

• Unwilling or unable to undergo treatment and follow-up assessments;
• Pregnant or breastfeeding women.

• The patient must voluntarily sign the informed consent form and demonstrate good compliance during follow-up.
• Age ≥18 years, both male and female participants are eligible.
• 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.
• Karnofsky Performance Status (KPS) score ≥60 before treatment.
• 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.
• 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.