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OncoMatch/Clinical Trials/NCT06818331

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

Is NCT06818331 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Paclitaxel and Specific mode electroacupuncture stimulation for glioma.

Phase 2RecruitingThe Third Affiliated hospital of Zhejiang Chinese Medical UniversityNCT06818331Data as of May 2026

Treatment: Paclitaxel · Specific mode electroacupuncture stimulationGliomas 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.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Disease stage

Required: Stage IV (WHO)

Grade: IV (WHO)

WHO grade IV glioma; at least one measurable lesion per RANO 2.0

Prior therapy

Must have received: surgical resection

Recurrence confirmed by cranial MRI after surgical resection.

Cannot have received: paclitaxel or similar drugs (paclitaxel)

Those who have received treatment containing paclitaxel or similar drugs.

Lab requirements

Blood counts

Hemoglobin ≥ 90.0 g/L; White blood cells ≥ 3.0*10^9/L; Absolute neutrophil count ≥ 1500/µL; Platelets ≥ 100*10^9/µl

Kidney function

Creatinine ≤ 1.5 mg/dL, estimated glomerular filtration rate ≥ 30 mL/min to < 90 mL/min

Liver function

Total bilirubin ≤ 5.0 x ULN; SGOT ≤ 3 x ULN and TbIL ≤ 3.0 x ULN

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)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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