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A Randomized Controlled Trial of Laser Interstitial Thermal Therapy Combined With Toripalimab for the Treatment of Recurrent High Grade Glioma

A Randomized Controlled Trial of Laser Interstitial Thermal Therapy Combined With Toripalimab for the Treatment of Recurrent High Grade Glioma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111588
Enrollment
Unknown
Registered
2025-11-03
Start date
2025-11-03
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent High Grade Glioma

Interventions

Combination therapy group:Laser interstitial thermal therapy +Toripalimab
Procedure/Surgery:Laser interstitial thermal therapy alone

Sponsors

Beijing Tiantan Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age range: 18-80 years old; 2.Patients with a histologically confirmed diagnosis of WHO CNS 5th edition grade 3 or 4 glioma who have previously received standard therapy. 3.No serious underlying diseases, blood routine, liver and kidney function, and coagulation function are basically normal; 4.Meet any of the following criteria: (1) Radiological progression according to the RANO criteria; (2) Evidence of disease progression on at least one imaging sequence other than T1 contrast-enhanced imaging; (3) Histopathological confirmation of tumor progression or recurrence. 5.All tumor lesions are located supratentorially, and the maximum short-axis diameter on the T1 contrast-enhanced sequence is = 30 mm. 6.Karnofsky Performance Status (KPS) >= 60, and the patient is considered able to tolerate interventional therapy. 7.No prior exposure to immune-related therapies. 8.The patient or legal guardian is able to understand the purpose of the study, comply with the study requirements, and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients who are likely to benefit from other treatments or unlikely to benefit from this study intervention. 2.Patients who have undergone craniotomy within the past 3 months. 3.Inability to undergo contrast-enhanced MRI examination. 4.Pregnant or lactating women, or women planning to become pregnant within 6 months. 5.Participation in another investigational drug or medical device trial within the past 3 months. 6.Presence of active or chronic autoimmune disease requiring immunosuppressive therapy (e.g., systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, or Crohn’s disease); history of active graft-versus-host disease (GVHD) or organ transplantation; active or uncontrolled infection; or other medical conditions that could interfere with treatment or outcome assessment. 7.Refusal or inability to complete study follow-up assessments. 8.Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
Progression free survival;

Secondary

MeasureTime frame
Ablation rate of lesions;Remaining volume of lesion;Overall Survival;

Countries

China

Contacts

Public ContactDabiao Zhou

Beijing Tiantan Hospital,Capital Medical University

dabiao@yeah.net+86 1370100856

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026