Recurrent High Grade Glioma Treated by LITT

NCT06161610 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Tiantan Hospital

Phase

Not applicable

Started

2023-09-19

Last updated

2024-11-29

Condition(s) studied

Recurrent High Grade Glioma

Investigational drug(s) / intervention(s)

LITTControl

LITT: The patients in the intervention group will receive LITT, other treatments, including systematic therapy and radiology therapy, would be not restricted except the craniotomy of resection before tumor progression or emergency. The patient is supposed to receive LITT post-randomization within 7 days.

Control: The patients in the control group will receive the best medical management under guidelines except LITT before tumor progression. Craniotomy will not be restricted,

Study summary

This clinical trial aims to investigate the efficiency and safety of laser interstitial thermal therapy (LITT) in recurrent high-grade glioma (rHGG) patients.

The main questions it aims to answer are:

* The LITT would increase the progression-free survival and overall survival of rHGG patients compared to other treatments.
* The LITT is safe and applicable to rHGG patients Participants will be randomized to the intervention group (LITT) or control group at a ratio of 2:1. The intervention group patients will receive LITT. The control group will be treated with any other treatment.

The primary outcome of this trial is progression-free survival. The estimated sample size is 135, 90 in the LITT group and 45 in the control group.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Progression-free survival — estimate 6 months
The progression was defined by RANO 2.0 criteria and assessed by the third-party clinical events committees which are blinded to the allocation.

Trial sites (9)

Facility	City	Region	Status
Beijing Tiantan Hospital	Beijing	Beijing Municipality	Recruiting
Beijing Tsinghua Changgung Hospital	Beijing	Beijing Municipality	Not Yet Recruiting
The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	Recruiting
The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	Recruiting
Tongji Hospital	Wuhan	Hubei	Recruiting
The First Hospital of Jilin University	Changchun	Jilin	Recruiting
The Peoples Hospital of Liaoning	Shenyang	Liaoning	Recruiting
Qilu Hospital	Jinan	Shandong	Recruiting
Huashan Hospital	Shanghai	Shanghai Municipality	Recruiting

More Beijing Tiantan Hospital trials in China

Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery Recruiting

Changes in Ciprofol Dosage in Patients With Insomnia Undergoing Intravenous Anesthesia Recruiting

Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma Active, not recruiting

PTCs-based Precision Treatment Strategy on Recurrent High-grade Gliomas Active, not recruiting

Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ Recruiting

Other trials for the same condition

PTCs-based Precision Treatment Strategy on Recurrent High-grade Gliomas Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06161610 on ClinicalTrials.gov ↗ ← All trials in China