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.
Treatment: Temozolomide(TMZ) · Albumin-Bound Paclitaxel(ABX) intravenous drip · Specific mode electroacupuncture stimulation(SMES) intervention — Gliomas 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.
Check if I qualifyExtracted 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);
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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