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

ConditionGlioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Third Affiliated hospital of Zhejiang Chinese Medical University

About this 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

Qualifiers

WHO grade IV glioma as defined in the "Integrated Diagnosis and Treatment Guidelines for Glioma of the Chinese Anti-Cancer Association" (V2.0_2025 (20250110)).

Recurrence confirmed by cranial MRI after surgical resection.

According to the Response Assessment in Neuro-Oncology Criteria, version 2.0 (RANO 2.0) standards, there is at least one measurable lesion.

Age ≥ 18 years and ≤ 70 years, gender not limited.

Disqualifiers

Seizure attack, uncontrollable.

Those who are currently participating in other clinical trials or have completed other clinical trials within less than one month.

Those who have received treatment containing paclitaxel or similar drugs.

Those who have a severe allergy to paclitaxel or similar substances.

Trial design

Treatments tested in this trial

  • SMES+PTX
  • Paclitaxel
  • Specific mode electroacupuncture stimulation

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityRecruiting310000, China, Hangzhou City, Zhejiang ProvinceChinaChina