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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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Phase: Phase 2/3 to Phase 2v3 Show 5 more changesShow less
    • Primary endpoints: 2 to 1
    • Enrollment target: 19 to 20
    • Eligibility criteria expanded, about 118 words
    • Secondary endpoints: 5 to 9
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary and study completion dates: Jan 14, 2028 to Feb 24, 2028
    • Start date changed from estimate of Feb 1, 2025 to Feb 10, 2025
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06818331
Lead Sponsor The Third Affiliated hospital of Zhejiang Chinese Medical University
Conditions
(from sponsor)		 Glioma
Related terms Glioma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov