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.
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.
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.
Single group
SMES+PTX
Other interventionThis intervention involves the combined use of medication and device, where the specific mode electroacupuncture stimulation (SMES) intervention is administered simultaneously with the intravenous infusion of paclitaxel.
Paclitaxel
DrugPaclitaxel is administered intravenously at a dose of 135-175mg/m², repeated every 3 weeks.
Specific mode electroacupuncture stimulation
DevicePatients assume a supine position. After routine skin disinfection with 75% ethanol, a stainless steel needle (size 0.25mm×40mm) is inserted into GV20 (Baihui), and another stainless steel needle (size 0.25mm×25mm, as described above) is inserted into GV26 (Shuigou). The acupoints are manually stimulated until the patient experiences soreness, distension, or heaviness (the "De Qi" response). Subsequently, the needles are stimulated using an acupuncture point nerve stimulator (HANS-200, Nanjing Jinsheng Ltd., China) at a frequency of 2/100 Hz and an intensity of 3 mA for 40 minutes (a homemade relay cycled power supply to the electrode, with 6 seconds on and 6 seconds off). The intervention is administered every three weeks, concurrently with paclitaxel treatment
4-month progression-free survival rate
Comprehensive neurological examinations and MRI scans were performed at baseline to establish the initial disease status. These assessments were repeated at specified post-treatment time points (weeks 3, 6, 9, 12, 15, and 18) to evaluate changes compared to baseline. Responses, including complete response , partial response, stable disease , and progressive disease, were assessed according to the specific criteria outlined in the RANO 2.0 guidelines.Finally, the proportion of subjects in the intent-to-treat population with progression-free survival exceeding 4 months was calculated.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30
The questionnaire consists of 30 items and covers multiple dimensions, such as physical function, role function, emotional function, social function, quality of life, fatigue, pain, and other cancer-related symptoms.
The Neurological Assessment for Neuro-Oncology (NANO)
NANO Scale quantitatively assesses nine neurological functions in patients, including gait, muscle strength, sensation, visual fields, facial strength, speech, cognition, and limb coordination, with each category scored between 0 to 3 or 0 to 2.
Overall survival(OS)
The time from enrollment to death for any reason (for lost-to-follow-up patients, the time of the last follow-up; for patients still alive at the end of the study, the time of the last follow-up).
Disease control rate
Disease control rate refers to the proportion of patients in the intent-to-treat population who achieved complete response , partial response , or stable disease , as assessed by the RANO 2.0 criteria.
Map coordinates are unavailable for these locations. Locations are shown below instead.
ChinaClick on the lead sponsor to view all of their trials.
