NCT06818331 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
| NCT ID | NCT06818331 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The Third Affiliated hospital of Zhejiang Chinese Medical University |
| Condition | Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2028-02-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-02-10 with a primary completion date of 2028-02-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion criteria 1. 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)). 2. Recurrence confirmed by cranial MRI after surgical resection. 3. According to the Response Assessment in Neuro-Oncology Criteria, version 2.0 (RANO 2.0) standards, there is at least one measurable lesion. 4. Age ≥ 18 years and ≤ 70 years, gender not limited. 5. If dexamethasone is used due to the space-occupying effect, the stable daily dose within 7 days before enrollment should be \< 6 mg; if the dose of dexamethasone is being reduced, the average daily dose within 7 days before enrollment should be \< 6 mg. Patients receiving dexamethasone treatment for reasons other than the space-occupying effect can still be enrolled. 6. Karnofsky Performance Status Score (KPS) ≥ 40 points or World Health Organization (WHO) Performance Status Score ≤ 3 points. 7. Good bone marrow function, liver and kidney function (within 14 days before treatment): a. Hemoglobin ≥ 90.0 g/L; b. White blood cells ≥ 3.0\*10\^9/L; c. Absolute neutrophil count ≥ 1500/µL (white blood cell count \* neutrophil percentage); d. Platelets ≥ 100\*10\^9/µl; e. Total bilirubin (TbIL) ≤ 5.0 x ULN; f. Serum aspartate aminotransferase (SGOT) ≤ 3 x ULN and TbIL ≤ 3.0 x ULN; g. Creatinine ≤ 1.5 mg/dL, estimated glomerular filtration rate ≥ 30 mL/min to \< 90 mL/min) 8. Able to receive electroacupuncture treatment and have good compliance. 9. Clear consciousness, pain perception and discrimination ability, and basic communication ability. 10. Signed the informed consent form and voluntarily participated in this study. Exclusion criteria 1. Seizure attack, uncontrollable. 2. Those who are currently participating in other clinical trials or have completed other clinical trials within less than one month. 3. Those who have received treatment containing paclitaxel or similar drugs. 4. Those who have a severe allergy to paclitaxel or similar substances. 5. Pregnant or lactating women. 6. Those with diseases affecting cognitive function such as congenital dementia, or alcoholics, drug addicts or those with abuse of psychotropic substances. 7. Those with infected skin at the acupuncture site. 8. Patients with metallic foreign bodies in their bodies. 9. Those who cannot undergo cranial enhanced MRI examination. 10. Other acute or chronic diseases, mental disorders or abnormal laboratory test values that may increase the risk associated with participating in the study or the administration of the study drug, or interfere with the interpretation of study results, and the investigator determines that the patient does not meet the eligibility criteria for participation in the study. 11. Those who are undergoing other types of anti-tumor treatments simultaneously during the trial, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06818331 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06818331 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06818331 currently recruiting?
Yes, NCT06818331 is actively recruiting participants. Contact the research team at linxianming1966@163.com for enrollment information.
Where is the NCT06818331 trial being conducted?
This trial is being conducted at China, China.
Who is sponsoring the NCT06818331 clinical trial?
NCT06818331 is sponsored by The Third Affiliated hospital of Zhejiang Chinese Medical University. The trial plans to enroll 20 participants.