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OncoMatch/Clinical Trials/NCT06330337

Effect of Electroacupuncture Combined With Paclitaxel Clinical Efficacy of Patients With Recurrence of High-grade Glioma

Is NCT06330337 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Temozolomide(TMZ) and Albumin-Bound Paclitaxel(ABX) intravenous drip for glioma.

Phase 3RecruitingThe Third Affiliated hospital of Zhejiang Chinese Medical UniversityNCT06330337Data as of May 2026

Treatment: Temozolomide(TMZ) · Albumin-Bound Paclitaxel(ABX) intravenous drip · Specific mode electroacupuncture stimulation(SMES) interventionGliomas are the most common type of primary brain tumors, with surgery followed by radiotherapy and chemotherapy as the main treatment modalities. However, they are highly prone to recurrence, presenting significant treatment challenges, especially for high-grade gliomas, which have a 5-year survival rate of only 5.5%. Paclitaxel, a common chemotherapeutic agent, exhibits antitumor effects in vitro that are 1400 times stronger than those 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, precluding 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 blood-brain barrier, enhancing the concentration of albumin-bound paclitaxel (ABX) in tumor tissues, peritumoral tissues, and surrounding invasive tissues, thereby exerting antitumor effects. Consequently, this study aims to observe the safety and efficacy of SMES combined with ABX in treating patients with recurrent high-grade gliomas postoperatively, to explore its mechanisms of action, extend survival, improve quality of life, and forge new theories and methods for the integrative treatment of brain tumors combining traditional Chinese and Western medicine.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Performance status

KARNOFSKY/WHO 70–2

Karnofsky Performance Score (KPS) ≥70 or a World Health Organization (WHO) performance status of ≤2

Prior therapy

Must have received: radiotherapy — post-surgical resection

standard radiotherapy and chemotherapy post-surgical resection deemed unsuccessful, and recurrence confirmed by imaging

Must have received: chemotherapy — post-surgical resection

standard radiotherapy and chemotherapy post-surgical resection deemed unsuccessful, and recurrence confirmed by imaging

Cannot have received: taxane (paclitaxel)

Previous treatment with paclitaxel or similar chemotherapeutic or biologic agents

Cannot have received: biologic agent

Previous treatment with paclitaxel or similar chemotherapeutic or biologic agents

Lab requirements

Blood counts

Hemoglobin ≥ 90.0 g/L; White blood cells ≥ 3.0x10^9/L; Absolute neutrophil count ≥ 1500/µL; Platelets ≥ 100x10^9/L

Kidney function

Creatinine ≤1.5 mg/dL, estimated creatinine clearance ≥ 30 mL/min to <90 mL/min

Liver function

Total bilirubin (TbIL) ≤5.0 x ULN; Serum aspartate aminotransferase (SGOT) ≤10 x ULN and TbIL >3 to ≤5.0 x ULN

Cardiac function

No severe cardiac dysfunction

Patients with severe cardiac, hepatic, renal, or hematologic dysfunction (criteria within 14 days prior to treatment include: a. Hemoglobin ≥ 90.0 g/L; b. White blood cells ≥ 3.010^9/L; c. Absolute neutrophil count ≥ 1500/µL; d. Platelets ≥ 10010^9/µL; e. Total bilirubin (TbIL) ≤5.0 x ULN; f. Serum aspartate aminotransferase (SGOT) ≤10 x ULN and TbIL >3 to ≤5.0 x ULN; g. Creatinine ≤1.5 mg/dL, estimated creatinine clearance ≥ 30 mL/min to <90 mL/min);

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