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.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically diagnosed as high-grade glioma, failed standard radiotherapy and chemotherapy after surgical resection, with radiological confirmation of recurrence.
2. Aged ≥18 and ≤70 years, regardless of gender.
3. If dexamethasone is administered due to mass effect, the stable daily dose of dexamethasone within 7 days prior to enrollment must be \<6 mg, or if the dexamethasone dose is being reduced, the average daily dose within 7 days prior to enrollment must be \<6 mg. Patients who receive dexamethasone for reasons other than mass effect may still be eligible for enrollment.
4. Karnofsky performance score ≥40 or WHO performance status score ≤3.
5. Meets the indications for acupuncture therapy, with no severe complications, capable of accepting acupuncture treatment, and demonstrating good compliance.
6. Clear consciousness, able to perceive and distinguish pain, and able to communicate at a basic level.
7. Signed informed consent form and voluntarily agreed to participate in this study.

Exclusion Criteria:

* 1. Uncontrolled seizures. 2. Peripheral neuropathy \> Grade 1. 3. Currently participating in another clinical trial or have participated in another clinical trial within the past 3 months.

  4. Prior treatment with paclitaxel-like chemical or biological compounds, or a history of allergic reactions.

  5. Severe dysfunction of the heart, liver, kidneys, or hematologic system (within 14 days prior to treatment: a. Hemoglobin ≥ 90.0 g/L; b. White blood cell count ≥ 3.0 × 10\^9/L; c. Absolute neutrophil count ≥ 1500/µL (white blood cell count × neutrophil percentage); d. Platelet count ≥ 100 × 10\^9/µL; e. Total bilirubin (TbIL) ≤ 5.0 × ULN; f. Serum AST (SGOT) ≤ 3 × ULN and TbIL ≤ 3.0 × ULN; g. Serum creatinine ≤ 1.5 mg/dL, estimated creatinine clearance ≥ 30 mL/min to \< 90 mL/min).

  6. Pregnant or breastfeeding women. 7. Diseases affecting cognitive function, such as congenital dementia, or individuals with a history of alcohol, drug, or psychotropic substance abuse.