Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Glioma
Keywords: glioma
Specific Mode Electroacupuncture Stimulation
Paclitaxel
blood-brain barrier
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: 4-month progression-free survival rate
timeFrame: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.
Secondary outcomes:
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30
timeFrame: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.
measure: The Neurological Assessment for Neuro-Oncology (NANO)
timeFrame: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.
measure: Overall survival(OS)
timeFrame: On the last day of weeks 3, 6, 9, 12, 15, and 18 during the treatment period; and then monthly during the follow-up phase for a total of 12 times.
measure: Disease control rate
timeFrame: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.
measure: Objective response rate
timeFrame: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.
measure: Progression-free survival
timeFrame: On the last day of weeks 3, 6, 9, 12, 15, and 18 during the treatment period; and then monthly during the follow-up phase for a total of 12 times.
measure: Duration of response
timeFrame: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18
measure: Duration of Disease Control
timeFrame: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18
measure: Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
timeFrame: On the 7th, 14th and 21st days of the 1st to 6th treatment cycles, each treatment cycle lasts for 21 days.
Other outcomes:
Locations:
city: China
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Hangzhou City, Zhejiang Province
Study officials:
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