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NCT Number: 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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Third Affiliated Hospital of Zhejiang Chinese Medical University

China, Hangzhou City, Zhejiang Province, 310000

Location status: Recruiting

Location contact

Jia

CONTACT

Zhaoxing Jia

CONTACT

[email protected]

+8618356130598

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

paclitaxel

Drug

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

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

Primary outcomes

  1. 4-month progression-free survival rate

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

    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.

Secondary outcomes

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

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

    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.

  2. The Neurological Assessment for Neuro-Oncology (NANO)

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

    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.

  3. Overall survival(OS)

    Time frame: 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.

    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).

  4. Disease control rate

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

    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.

  5. Objective response rate

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

    Objective response rate refers to the proportion of patients in the intent-to-treat population who achieved complete response or partial response , as assessed per the RANO 2.0 criteria.

  6. Progression-free survival

    Time frame: 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.

    Progression-free survival was defined as the time interval from the initiation of SMES combined with ABX treatment until the first occurrence of any of the following events: radiographic disease progression as determined by Response Assessment in Neuro-Oncology (RANO) version 2.0 criteria, the development of intolerable treatment-related adverse events leading to treatment discontinuation, or death due to any cause.

  7. Duration of response

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

    Duration of response was defined as the time interval between the first administration of SMES plus ABX therapy and the occurrence of disease progression.

  8. Duration of Disease Control

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

    Duration of Disease Control was defined as the time interval from when a patient first achieved disease control (complete response , partial response , or stable disease until disease progression or death, whichever occurred first.

  9. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

    Time frame: On the 7th, 14th and 21st days of the 1st to 6th treatment cycles, each treatment cycle lasts for 21 days.

    Adverse reactions were recorded from the time of informed consent signing through the final visit, including any emerging symptoms, signs, and laboratory abnormalities. Common adverse reactions may include skin discomfort, pruritus, pain, etc., with severity graded into 5 levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Xianming Lin PHD

CONTACT

[email protected]

+86-13858028101

Zhaoxing Jia, PHD

CONTACT

[email protected]

+86-18356130598

Sponsors and collaborators

Lead sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 10, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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