NCT04967027

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

• Brain Metastases

Interventions

Type	Name	Description
DEVICE	ASCLU-300 TTF	BM treated by continuous TTFields treatment (ASCLU-300, approved by Chinese FDA)

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-08-01
• Completion: 2022-12-01
• First posted: 2021-07-19
• Last updated: 2022-03-02

Locations

1 site across 1 country: China