A prospective, single-center, single-arm, exploratory study on the treatment of recurrent glioblastoma with Tumor Eletric Fields Treatment System

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000032655

Enrollment

Unknown

Registered

2020-05-05

Start date

2020-05-06

Completion date

Unknown

Last updated

2020-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glioblastoma

Interventions

Intervention:Tumor Eletric Fields Treatment System

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Pathological diagnosis of glioblastoma at first surgery(WHO Grade IV,supratentorial location); 2. 18-65 years old ( >= 18 years old, = 70 before intervention; 6. Life expectancy >= 3 months; 7. Participants of child-bearing age who adopts effective contraceptive measures; 8. All patients must sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Unwilling to use the equipment >= 18h per day; 2. Patients with poor compliance or live too far from the research center, who cannot keep regular follow-up or adjust the electrode position of the treatment equipment, and who refuse to receive follow-up to terminal survival; 3. Patient with poor healing of scalp wound, poor scalp condition, large skull defect or other cases where electrodes are not suitable for wearing; 4. Within 3 months from radiotherapy; Within 4 weeks from the last cycle of chemotherapy; Within 4 weeks from surgery for recurrence; Candidates who has participated in other clinical trials. 5. Pregnant; 6. Epilepsy symptoms not effectively controlled; 7. 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 of normal value; C. Renal impairment: serum creatinine>1.7mg /dL (>150 mol/L); D. Coagulopathy: PT or APTT >1.5 times normal; E. Platelets counts 5mm, clinically significant papilledema or reduced level of consciousness, allergy to conductive coupling agent, gel, and other serious life-threatening diseases. 10. Other circumstances considered inappropriate to participate in the research by investigator.

Design outcomes

Primary

Measure	Time frame
Frequency of adverse events and serious adverse events;	—

Secondary

Measure	Time frame
Time to Progression;Overall Survival;	—

Countries

China

Contacts

Public ContactZhixiong Liu

Xiangya Hospital Central South University

zhixiongliu@csu.edu.cn+86 13607318785

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026