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

NCT06818331 | Recruiting Phase 2 DMC

• 1 other identifier: ZSLL-KY-2024-079-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Keywords

glioma; Specific Mode Electroacupuncture Stimulation; Paclitaxel; blood-brain barrier

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.

Secondary Outcomes (9)

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30

  baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.

• The Neurological Assessment for Neuro-Oncology (NANO)

  baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.

• Overall survival(OS)

  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.

• Disease control rate

  baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.

• Objective response rate

  baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.

Study Arms (1)

Treatment group

EXPERIMENTAL

Patients in the treatment group received both paclitaxel(PTX) and a specific mode electroacupuncture stimulation（SMES） . Drug: Paclitaxel is administered intravenously at a dose of 135-175mg/m², repeated every 3 weeks. Device: SMES immediately after the ABX intravenous infusion began, the patient was placed in a supine position, the skin was routinely disinfected with 75% ethanol, and a stainless steel needle was inserted into GV20 and GV26.Then, the needles are stimulated by using an acupuncture point nerve stimulator with a frequency of 2/100 Hz and an intensity of 3 mA for 40 min (a homemade relay cycled power to the electrode for 6 sec on and 6 sec off).

Other: SMES+PTX; Drug: Paclitaxel; Device: Specific mode electroacupuncture stimulation

Interventions

SMES+PTX OTHER

This 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.

Treatment group

Paclitaxel DRUG

Paclitaxel is administered intravenously at a dose of 135-175mg/m², repeated every 3 weeks.

Treatment group

Specific mode electroacupuncture stimulation DEVICE

Patients 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

Treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Karnofsky Performance Status Score (KPS) ≥ 40 points or World Health Organization (WHO) Performance Status Score ≤ 3 points.
• 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)
• Able to receive electroacupuncture treatment and have good compliance.
• Clear consciousness, pain perception and discrimination ability, and basic communication ability.
• Signed the informed consent form and voluntarily participated in this study.

You may not qualify if:

• 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.
• Pregnant or lactating women.
• Those with diseases affecting cognitive function such as congenital dementia, or alcoholics, drug addicts or those with abuse of psychotropic substances.
• Those with infected skin at the acupuncture site.
• Patients with metallic foreign bodies in their bodies.
• Those who cannot undergo cranial enhanced MRI examination.
• 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.
• Those who are undergoing other types of anti-tumor treatments simultaneously during the trial, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

China, Hangzhou City, Zhejiang Province, 310000, China

RECRUITING

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MeSH Terms

Conditions

Glioma

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Xianming Lin PHD

CONTACT

+86-13858028101; linxianming1966@163.com

Zhaoxing Jia, PHD

CONTACT

+86-18356130598; zhenxinzhenyi183@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 10, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): February 24, 2028
• Study Completion (Estimated): February 24, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)