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Tests treatment safety and results for Glioma
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
ClinicalTrials.gov ID: NCT06818331
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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%.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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...
- 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...
You likely can't join 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...
See the full eligibility 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...
- 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 \...
- 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.
- 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...
- Those who are undergoing other types of anti-tumor treatments simultaneously during the trial, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
The study team makes the final eligibility decision.
Where it's taking place
- China, Hangzhou City, Zhejiang Province, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China, Hangzhou City, Zhejiang Province, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.