Laser treatment for recurrent high-grade glioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and effectiveness of laser interstitial thermal therapy (LITT) for patients with recurrent high-grade glioma (rHGG). Participants will be randomly assigned to receive either LITT or standard treatment, with the primary goal of assessing progression-free survival. The study aims to enroll 135 patients, with 90 receiving LITT and 45 in the control group. The trial will evaluate whether LITT can improve survival outcomes compared to existing therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18 years old or above;
2. Patients with previous pathological diagnosis of 2021 World Health Organization Classification of Central Nervous System Tumors (WHO CNS5) grade 3 or 4 glioma and received standard treatment;
3. Meet any of the following:

   1. Meets the disease progression criteria in the Response Evaluation of Neuro-Oncology (RANO 2.0) criteria;
   2. At least one image other than T1 contrast indicates progression;
   3. Pathology shows progression or recurrence;
   4. Other progress determined by the Clinical Events Committee (CEC);
4. All tumor lesions are located supratentorial and the maximum cross-sectional short-axis length in the T1 contrast is ≤30 mm;
5. Karnofsky score (KPS) ≥ 60 and the patient can tolerate the intervention;
6. The subjects or their agent can understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent form.

Exclusion Criteria:

1. Patients may benefit from other treatments or may not benefit from this trial;
2. No more than three months since the patient underwent craniotomy;
3. MRI contrast cannot be performed;
4. Severe coagulation disorder;
5. Women who are pregnant, lactating, or planning to become pregnant within 6 months;
6. Participated in any other clinical trials of drugs or medical devices within 3 months;
7. Combined diseases that may interfere with treatment or prognosis assessment;
8. Refuse or unlikely to complete follow-up assessment;
9. Other circumstances in which the researcher deems it inappropriate to participate in this clinical trial.

Where it's running

• Beijing Tiantan Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Tongji Hospital
  Wuhan, Hubei, China Recruiting
• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting
• The Peoples Hospital of Liaoning
  Shenyang, Liaoning, China Recruiting

Study contacts

• Principal investigator: Tao Jiang, MD — Beijing Tiantan Hospital
• Study coordinator: Yunke Li, MD
• Email: liyunke@sinovationmed.com
• Phone: 0086-010-67088936

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combining Temozolomide with Abexinostat for Recurrent Glioma Treatment

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.