Clinical trial · Interventional
Tumor Electric Fields Treatment System for Glioblastoma
A Prospective, Single-center, Single-arm, Exploratory Study on the Treatment of Recurrent Glioblastoma With Tumor Electric Fields Treatment System
NCT04417933CI-TRIAL-00045515unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This early phase I trial will investigate the safety and feasibility of applying the Tumor Electric Fields Treatment System to subjects with recurrent glioblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor Electric Fields Treatment System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumor Electric Fields Treatment System
- description
- Patients have a histologically confirmed diagnosis of supratentorial glioblastoma that is recurrent. All patients will receive Tumor Electric Fields Treatment System.
- interventionNames
- Device: Tumor Electric Fields Treatment System
Primary outcomes (3)
- measure
- The treatment-related adverse events
- timeFrame
- 12 months
- description
- Number of patients who experienced a treatment-related adverse event.
- measure
- Time to Progression
- timeFrame
- 12 months
- description
- Time to progression of patients with recurrent glioblastoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 regular follow-up or adjust the electrode position of the treatment equipment, and who refuse to receive follow-up to terminal survival; * With poor healing of scalp wound, poor scalp condition, large skull defect or other cases 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 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 \< 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 midline shift\>5mm, clinically significant papilledema, or reduced level of consciousness, allergy to conductive coupling agent, gel, and other serious life-threatening diseases. * Other circumstances considered inappropriate to participate in the research by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.