Actively Recruiting
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
Led by The Third Affiliated hospital of Zhejiang Chinese Medical University · Updated on 2025-06-04
20
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with WHO grade IV glioma according to Chinese Anti-Cancer Association guidelines
- Recurrence confirmed by cranial MRI after surgery
- At least one measurable lesion by RANO 2.0 criteria
- Aged 18 to 70 years, any gender
- Stable dexamethasone dose under 6 mg daily if used for space-occupying effects
- Karnofsky Performance Status score of 40 or higher or WHO Performance Status 3 or lower
- Adequate bone marrow, liver, and kidney function within 14 days before treatment
- Able to receive electroacupuncture treatment with good compliance
- Clear consciousness, pain perception, and basic communication ability
- Signed informed consent and voluntarily agreed to participate
You will not qualify if you...
- Uncontrollable seizure attacks
- Currently in or completed another clinical trial within one month
- Prior treatment with paclitaxel or similar drugs
- Severe allergy to paclitaxel or similar substances
- Pregnant or breastfeeding women
- Diseases affecting cognitive function or substance abuse
- Infected skin at acupuncture sites
- Presence of metallic foreign bodies in the body
- Unable to undergo cranial enhanced MRI
- Other acute or chronic diseases, mental disorders, or abnormal labs increasing study risk
- Receiving other anti-tumor treatments such as chemotherapy, radiotherapy, targeted therapy, or immunotherapy during the trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Zhejiang Chinese Medical University
China, Hangzhou City, Zhejiang Province, China, 310000
Actively Recruiting
Research Team
X
Xianming Lin PHD
CONTACT
Z
Zhaoxing Jia, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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