GliomaPhase 2NCT06818331
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
A Phase 2 study testing SMES+PTX, Paclitaxel and Specific mode electroacupuncture stimulation in people with Glioma, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma
- What is being tested?
- SMES+PTX, Paclitaxel and Specific mode electroacupuncture stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to 24 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Zhejiang Chinese Medical University
China, Hangzhou City, Zhejiang Province, 310000
Zhaoxing Jia, +8618356130598, zhenxinzhenyi183@163.com
Jia
About this study
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
- Being tested
- SMES+PTX, Paclitaxel, Specific mode electroacupuncture stimulation
- Keywords
- glioma, Specific Mode Electroacupuncture Stimulation, Paclitaxel, blood-brain barrier
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMES+PTXOther
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.
PaclitaxelDrug
Paclitaxel is administered intravenously at a dose of 135-175mg/m², repeated every 3 weeks.
Specific mode electroacupuncture stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: SMES+PTX; Drug: Paclitaxel; Device: Specific mode electroacupuncture stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.
The Neurological Assessment for Neuro-Oncology (NANO)
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.
Measured: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.
Overall survival(OS)
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).
Measured: 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
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.
Measured: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.
Objective response rate
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.
Measured: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.
Progression-free survival
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.
Measured: 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.
Duration of response
Duration of response was defined as the time interval between the first administration of SMES plus ABX therapy and the occurrence of disease progression.
Measured: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18
Duration of Disease Control
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.
Measured: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18
Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
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.
Measured: On the 7th, 14th and 21st days of the 1st to 6th treatment cycles, each treatment cycle lasts for 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start10 Feb 2025
- Primary completion24 Feb 2028 (estimated)
- Study completion24 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianming Lin, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818331
- Sponsor's protocol ID
- ZSLL-KY-2024-079-01
- Status last verified
- May 2025
- First submitted
- 5 Feb 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data and results of this study need to be confirmed by Lin Xianming
Publications
Chamberlain MC, Kormanik P. Salvage chemotherapy with paclitaxel for recurrent primary brain tumors. J Clin Oncol. 1995 Aug;13(8):2066-71. doi: 10.1200/JCO.1995.13.8.2066.
PubMed 7636549Chang SM, Kuhn JG, Robins HI, Schold SC Jr, Spence AM, Berger MS, Mehta M, Pollack IF, Rankin C, Prados MD. A Phase II study of paclitaxel in patients with recurrent malignant glioma using different doses depending upon the concomitant use of anticonvulsants: a North American Brain Tumor Consortium report. Cancer. 2001 Jan 15;91(2):417-22. doi: 10.1002/1097-0142(20010115)91:23.0.co;2-9.
PubMed 11180089Barretina J, Caponigro G, Stransky N, Venkatesan K, Margolin AA, Kim S, Wilson CJ, Lehar J, Kryukov GV, Sonkin D, Reddy A, Liu M, Murray L, Berger MF, Monahan JE, Morais P, Meltzer J, Korejwa A, Jane-Valbuena J, Mapa FA, Thibault J, Bric-Furlong E, Raman P, Shipway A, Engels IH, Cheng J, Yu GK, Yu J, Aspesi P Jr, de Silva M, Jagtap K, Jones MD, Wang L, Hatton C, Palescandolo E, Gupta S, Mahan S, Sougnez C, Onofrio RC, Liefeld T, MacConaill L, Winckler W, Reich M, Li N, Mesirov JP, Gabriel SB, Getz G, Ardlie K, Chan V, Myer VE, Weber BL, Porter J, Warmuth M, Finan P, Harris JL, Meyerson M, Golub TR, Morrissey MP, Sellers WR, Schlegel R, Garraway LA. The Cancer Cell Line Encyclopedia enables predictive modelling of anticancer drug sensitivity. Nature. 2012 Mar 28;483(7391):603-7. doi: 10.1038/nature11003.
PubMed 22460905Caffery B, Lee JS, Alexander-Bryant AA. Vectors for Glioblastoma Gene Therapy: Viral & Non-Viral Delivery Strategies. Nanomaterials (Basel). 2019 Jan 16;9(1):105. doi: 10.3390/nano9010105.
PubMed 30654536Zhang S, Gong P, Zhang J, Mao X, Zhao Y, Wang H, Gan L, Lin X. Specific Frequency Electroacupuncture Stimulation Transiently Enhances the Permeability of the Blood-Brain Barrier and Induces Tight Junction Changes. Front Neurosci. 2020 Oct 6;14:582324. doi: 10.3389/fnins.2020.582324. eCollection 2020.
PubMed 33122995Park J, Aryal M, Vykhodtseva N, Zhang YZ, McDannold N. Evaluation of permeability, doxorubicin delivery, and drug retention in a rat brain tumor model after ultrasound-induced blood-tumor barrier disruption. J Control Release. 2017 Mar 28;250:77-85. doi: 10.1016/j.jconrel.2016.10.011. Epub 2016 Oct 11.
PubMed 27742444Siegal T, Rubinstein R, Bokstein F, Schwartz A, Lossos A, Shalom E, Chisin R, Gomori JM. In vivo assessment of the window of barrier opening after osmotic blood-brain barrier disruption in humans. J Neurosurg. 2000 Apr;92(4):599-605. doi: 10.3171/jns.2000.92.4.0599.
PubMed 10761648Graham-Gurysh EG, Murthy AB, Moore KM, Hingtgen SD, Bachelder EM, Ainslie KM. Synergistic drug combinations for a precision medicine approach to interstitial glioblastoma therapy. J Control Release. 2020 Jul 10;323:282-292. doi: 10.1016/j.jconrel.2020.04.028. Epub 2020 Apr 23.
PubMed 32335153Tosi U, Kommidi H, Adeuyan O, Guo H, Maachani UB, Chen N, Su T, Zhang G, Pisapia DJ, Dahmane N, Ting R, Souweidane MM. PET, image-guided HDAC inhibition of pediatric diffuse midline glioma improves survival in murine models. Sci Adv. 2020 Jul 24;6(30):eabb4105. doi: 10.1126/sciadv.abb4105. eCollection 2020 Jul.
PubMed 32832670Zagouri F, Zoumpourlis P, Le Rhun E, Bartsch R, Zografos E, Apostolidou K, Dimopoulos MA, Preusser M. Intrathecal administration of anti-HER2 treatment for the treatment of meningeal carcinomatosis in breast cancer: A metanalysis with meta-regression. Cancer Treat Rev. 2020 Aug;88:102046. doi: 10.1016/j.ctrv.2020.102046. Epub 2020 Jun 3.
PubMed 32599393Malani R, Fleisher M, Kumthekar P, Lin X, Omuro A, Groves MD, Lin NU, Melisko M, Lassman AB, Jeyapalan S, Seidman A, Skakodub A, Boire A, DeAngelis LM, Rosenblum M, Raizer J, Pentsova E. Cerebrospinal fluid circulating tumor cells as a quantifiable measurement of leptomeningeal metastases in patients with HER2 positive cancer. J Neurooncol. 2020 Jul;148(3):599-606. doi: 10.1007/s11060-020-03555-z. Epub 2020 Jun 6.
PubMed 32506369Fowler MJ, Cotter JD, Knight BE, Sevick-Muraca EM, Sandberg DI, Sirianni RW. Intrathecal drug delivery in the era of nanomedicine. Adv Drug Deliv Rev. 2020;165-166:77-95. doi: 10.1016/j.addr.2020.02.006. Epub 2020 Mar 3.
PubMed 32142739Agarwal S, Sane R, Oberoi R, Ohlfest JR, Elmquist WF. Delivery of molecularly targeted therapy to malignant glioma, a disease of the whole brain. Expert Rev Mol Med. 2011 May 13;13:e17. doi: 10.1017/S1462399411001888.
PubMed 21676290Cardoso FL, Brites D, Brito MA. Looking at the blood-brain barrier: molecular anatomy and possible investigation approaches. Brain Res Rev. 2010 Sep 24;64(2):328-63. doi: 10.1016/j.brainresrev.2010.05.003. Epub 2010 May 26.
PubMed 20685221Terstappen GC, Meyer AH, Bell RD, Zhang W. Strategies for delivering therapeutics across the blood-brain barrier. Nat Rev Drug Discov. 2021 May;20(5):362-383. doi: 10.1038/s41573-021-00139-y. Epub 2021 Mar 1.
PubMed 33649582
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- ZSLL-KY-2024-079-01
- Conditions
- Glioma
- Keywords
- glioma, Specific Mode Electroacupuncture Stimulation, Paclitaxel, blood-brain barrier
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 24 Feb 2028 (estimated)
- Study completion
- 24 Feb 2028 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: SMES+PTX, Drug: Paclitaxel, Device: Specific mode electroacupuncture stimulationPatients 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMES+PTXThis 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. | Other | Treatment group |
| PaclitaxelPaclitaxel is administered intravenously at a dose of 135-175mg/m², repeated every 3 weeks. | Drug | Treatment group |
| Specific mode electroacupuncture stimulationPatients 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 | Device | Treatment group |
Primary outcome
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.
9 secondary outcomes
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 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.
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.
Disease control rate
Time frame: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.
Objective response rate
Time frame: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18.
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.
Duration of response
Time frame: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18
Duration of Disease Control
Time frame: baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Background: PubMed 7636549Chamberlain MC, Kormanik P. Salvage chemotherapy with paclitaxel for recurrent primary brain tumors. J Clin Oncol. 1995 Aug;13(8):2066-71. doi: 10.1200/JCO.1995.13.8.2066.
- Background: PubMed 11180089Chang SM, Kuhn JG, Robins HI, Schold SC Jr, Spence AM, Berger MS, Mehta M, Pollack IF, Rankin C, Prados MD. A Phase II study of paclitaxel in patients with recurrent malignant glioma using different doses depending upon the concomitant use of anticonvulsants: a North American Brain Tumor Consortium report. Cancer. 2001 Jan 15;91(2):417-22. doi: 10.1002/1097-0142(20010115)91:23.0.co;2-9.
- Background: PubMed 22460905Barretina J, Caponigro G, Stransky N, Venkatesan K, Margolin AA, Kim S, Wilson CJ, Lehar J, Kryukov GV, Sonkin D, Reddy A, Liu M, Murray L, Berger MF, Monahan JE, Morais P, Meltzer J, Korejwa A, Jane-Valbuena J, Mapa FA, Thibault J, Bric-Furlong E, Raman P, Shipway A, Engels IH, Cheng J, Yu GK, Yu J, Aspesi P Jr, de Silva M, Jagtap K, Jones MD, Wang L, Hatton C, Palescandolo E, Gupta S, Mahan S, Sougnez C, Onofrio RC, Liefeld T, MacConaill L, Winckler W, Reich M, Li N, Mesirov JP, Gabriel SB, Getz G, Ardlie K, Chan V, Myer VE, Weber BL, Porter J, Warmuth M, Finan P, Harris JL, Meyerson M, Golub TR, Morrissey MP, Sellers WR, Schlegel R, Garraway LA. The Cancer Cell Line Encyclopedia enables predictive modelling of anticancer drug sensitivity. Nature. 2012 Mar 28;483(7391):603-7. doi: 10.1038/nature11003.
- Background: PubMed 30654536Caffery B, Lee JS, Alexander-Bryant AA. Vectors for Glioblastoma Gene Therapy: Viral & Non-Viral Delivery Strategies. Nanomaterials (Basel). 2019 Jan 16;9(1):105. doi: 10.3390/nano9010105.
- Background: PubMed 33122995Zhang S, Gong P, Zhang J, Mao X, Zhao Y, Wang H, Gan L, Lin X. Specific Frequency Electroacupuncture Stimulation Transiently Enhances the Permeability of the Blood-Brain Barrier and Induces Tight Junction Changes. Front Neurosci. 2020 Oct 6;14:582324. doi: 10.3389/fnins.2020.582324. eCollection 2020.
- Background: PubMed 27742444Park J, Aryal M, Vykhodtseva N, Zhang YZ, McDannold N. Evaluation of permeability, doxorubicin delivery, and drug retention in a rat brain tumor model after ultrasound-induced blood-tumor barrier disruption. J Control Release. 2017 Mar 28;250:77-85. doi: 10.1016/j.jconrel.2016.10.011. Epub 2016 Oct 11.
- Background: PubMed 10761648Siegal T, Rubinstein R, Bokstein F, Schwartz A, Lossos A, Shalom E, Chisin R, Gomori JM. In vivo assessment of the window of barrier opening after osmotic blood-brain barrier disruption in humans. J Neurosurg. 2000 Apr;92(4):599-605. doi: 10.3171/jns.2000.92.4.0599.
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- Individual participant dataSharing planned: No. The data and results of this study need to be confirmed by Lin Xianming
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SMES+PTX, Paclitaxel and Specific mode electroacupuncture stimulation in people with Glioma, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianming Lin PHD (+86-13858028101, linxianming1966@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06818331, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.