Evaluation of Clinical Efficacy and Safety of Specific Mode Electroacupuncture Stimulation for Paclitaxel Across BBB Delivery in Patients With Postoperative Recurrence of Malignant Glioma: A Single-arm Trial
Gliomas are the most common type of primary brain tumors, with the main treatment modalities including surgery, radiotherapy, and chemotherapy. However, gliomas are highly prone to recurrence, posing significant treatment challenges, especially for high-grade gliomas, which have a 5-year survival rate of only 5.5%. Paclitaxel (PTX) is a common chemotherapeutic agent, and its in vitro antitumor efficacy is 1400 times stronger than that of temozolomide (the first-line chemotherapy drug for gliomas). However, due to its large molecular weight (approximately 893 Da), it cannot cross the blood-brain barrier (BBB), preventing its use as a first-line treatment for gliomas. Preliminary research by our team has demonstrated that Specific Mode Electroacupuncture Stimulation (SMES) can open the BBB, increasing the concentration of PTX in tumor tissues, peritumoral tissues, and surrounding invasive tissues, thereby exerting antitumor effects. Therefore, this study aims to preliminarily observe the safety and efficacy of SMES combined with PTX in treating patients with postoperative recurrent high-grade gliomas.
• WHO grade IV glioma as defined in the Integrated Diagnosis and Treatment Guidelines for Glioma of the Chinese Anti-Cancer Association (V2.0\_2025 (20250110)).
• Recurrence confirmed by cranial MRI after surgical resection.
• According to the Response Assessment in Neuro-Oncology Criteria, version 2.0 (RANO 2.0) standards, there is at least one measurable lesion.
• Age ≥ 18 years and ≤ 70 years, gender not limited.
• If dexamethasone is used due to the space-occupying effect, the stable daily dose within 7 days before enrollment should be \< 6 mg; if the dose of dexamethasone is being reduced, the average daily dose within 7 days before enrollment should be \< 6 mg. Patients receiving dexamethasone treatment for reasons other than the space-occupying effect can still be enrolled.
• Karnofsky Performance Status Score (KPS) ≥ 40 points or World Health Organization (WHO) Performance Status Score ≤ 3 points.
• Good bone marrow function, liver and kidney function (within 14 days before treatment): a. Hemoglobin ≥ 90.0 g/L; b. White blood cells ≥ 3.0\*10\^9/L; c. Absolute neutrophil count ≥ 1500/µL (white blood cell count \* neutrophil percentage); d. Platelets ≥ 100\*10\^9/µl; e. Total bilirubin (TbIL) ≤ 5.0 x ULN; f. Serum aspartate aminotransferase (SGOT) ≤ 3 x ULN and TbIL ≤ 3.0 x ULN; g. Creatinine ≤ 1.5 mg/dL, estimated glomerular filtration rate ≥ 30 mL/min to \< 90 mL/min)
• Able to receive electroacupuncture treatment and have good compliance.
• Clear consciousness, pain perception and discrimination ability, and basic communication ability.
⁃ Signed the informed consent form and voluntarily participated in this study.