Tumor Electric Fields Treatment System for Glioblastoma

Inclusion Criteria:

• Patients with pathological diagnosis of glioblastoma at first surgery (WHO Grade IV,supratentorial location);

• Age between 18 and 65 years, male or female;

• Previously completed radiotherapy and at least two cycles of chemotherapy;

• With imaging or pathological evidence of tumor recurrence;

• Karnofsky performance score (KPS) score ≥ 70 before intervention;

• With a life expectancy more than 3 months;

• Adopted effective contraceptive measures at child-bearing age;

• Provided written informed consent.

Exclusion Criteria:

• Patients unwilling to use the equipment ≥ 18h per day;

• With poor compliance or live too far from the research center, who cannot keep regularfollow-up or adjust the electrode position of the treatment equipment, and who refuseto receive follow-up to terminal survival;

• With poor healing of scalp wound, poor scalp condition, large skull defect or othercases where electrodes are not suitable for wearing;

• Within 3 months from radiotherapy;

• Within 4 weeks from the last cycle of chemotherapy;

• Within 4 weeks from surgery for recurrence;

• Participated in other clinical trials.

• Pregnant;

• Epilepsy symptoms not effectively controlled;

• Blood and biochemical indicators in the following range: A. Liver function impairment:AST or ALT > 3 times the upper limit of normal; B. Total bilirubin> upper limit ofnormal value; C. Renal impairment: serum creatinine>1.7mg /dL (>150 mol/L); D.Coagulopathy: PT or APTT >1.5 times normal; E. Platelets counts < 100x10^9/L; F.Absolute neutrophils count < 1x10^9/L; G. Hemoglobin < 100g/L;

• With severe infectious diseases, such as acute severe infection and HIV positive;

• Other conditions, such as an implanted cardiac pacemaker or deep brain stimulator,severe intracranial edema, increased intracranial pressure resulting in midlineshift>5mm, clinically significant papilledema, or reduced level of consciousness,allergy to conductive coupling agent, gel, and other serious life-threateningdiseases.

• Other circumstances considered inappropriate to participate in the research by theinvestigator.