JMIR Publications

ABSTRACT

Background:

Despite advances in surgical resection, radiotherapy, and chemotherapy, the prognosis of recurrent malignant gliomas (rMG) remains poor, with limited efficacy of conventional treatments due to the blood-brain barrier (BBB) hindering drug delivery to the tumor site. Studies have demonstrated that albumin-bound paclitaxel (ABX), while potent in vitro, is restricted in its intravenous use due to BBB limitations. To overcome this, specific-mode electrical stimulation (SMES) has shown promise in transiently opening the BBB, enhancing the accumulation of ABX in glioma tumors.Therefore, this protocol designs a single-center, single-arm, prospective phase II clinical trial aiming to evaluate the safety and clinical efficacy of SMES combined with ABX (SMES+ABX) for treating rMG.

Objective:

This study primarily evaluates the safety of SMES+ABX therapy in treating rMG patients and assesses whether it can improve the 4-month progression-free survival (4m-PFS) rate, while providing data support for future large-scale clinical trials.

Methods:

In this study, 20 eligible patients will receive intravenous ABX (135–175 mg/m²) per 21-day cycle for 6 cycles, combined with SMES for BBB modulation. A Simon’s two-stage design will be employed, with the primary endpoint being the 4m-PFS. Secondary endpoints include adverse events (AEs), disease control rate (DCR), objective response rate (ORR), duration of disease control (DDC), duration of response (DOR), Neurological Assessment in Neuro-Oncology (NANO) score, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), progression-free survival (PFS), and overall survival (OS).

Results:

(Anticipated) Results will determine the 4-month PFS rate, overall safety profile, secondary efficacy outcomes, and patient-reported quality of life measures. Data will be analyzed upon trial completion.

Conclusions:

This study will assess whether SMES-enhanced ABX delivery improves outcomes rMG patients by overcoming BBB limitations. If successful, the combination could offer a promising therapeutic strategy for this challenging patient population. Clinical Trial: ClinicalTrials.gov (Identifier: NCT06818331)