Clinical trial · Interventional
Phase 1 Trial for Tumor Treating Field for Drug/Radiation Resistant Brain Metastases
Safety and Tolerability of TTFields for Patients With Brain Metastases After the Standard Treatment Fails: a Prospective, Single-center, Single-arm Study
- 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)
Brain metastasis is a very common disease with poor prognosis, 20% cancer will develop brain metastases(BM), up to 40% by autopsy. Great advances have made with the application of targeting therapy, immunotherapy, chemotherapy, whole brain radiation and radiosurgery, however, treated patients were finally suffered from drug/radiation resistance and rapid recurrence. Tumor treating fields (TTFields) is one of the standard combination treatment for GBM, and some researchers believe that TTFields can effectively inhibit patient-derived lung adenocarcinoma brain metastasis cells progression in vitro. In this study, the investigator attempts to evaluate the safety, and tolerability of TTFields in adult participants diagnosed with Drug/Radiation resistant BM.
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 |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ASCLU-300 TTF | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TTFields group
- description
- patients with brain metastases who have been resistant to drug or radiation therapy, to be treated by continuous TTFields treatment using the ASCLU-300 TTF device.
- interventionNames
- Device: ASCLU-300 TTF
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 brain metastases
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * patients are diagnosed as brain metastases by Xiangya Hospital multidisciplinary team; * age from 18 to 65 year-old; * patients have been progressed from standard therapy (drug/radiation resistance) * KPS more than 70 score; * anticipated OS more than 3 months; * signed consent form. Exclusion Criteria: * unable to take TTFields more than 18 hours each day; * unable to follow-up till progression; * the scalp wound is not well healed, the head skin condition is not good, the skull has a large area defect, or other situations that are not suitable for wearing electrodes * pregnant women; * last drug within 4 weeks, last radiation within 3 months, take other trials; * other heavy diseases like heavy infection; * other condition: Such as breastfeeding, installation of cardiac pacemakers, brain stimulators, severe intracranial edema, increased intracranial pressure leading to midline structures exceeding 5 mm, optic nerve head edema, disturbance of consciousness, etc., allergies to conductive coupling agents, gels, etc. * 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; * other conditions physicians not suggest to take the trial
References
Publications (0)
Data not yet available