RecruitingPhase 2NCT06220552

The Efficacy and Safety of Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma

Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma: A Single-arm, Prospective Phase II Clinical Study


Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Enrollment

20 participants

Start Date

Dec 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of low-dose radiotherapy combined with programmed death 1 (PD-1) inhibitor (sintilimab) and temozolomide in recurrent glioblastoma. The eligible patients are scheduled to administered sintilimab 200mg D1 Q3W temozolomide 50mg/m2 QD and radiotherapy 1Gy/1F D1/D2/D8/D15 Q3W for 4-6 cycles, then sintilimab for maintenance. The overall primary study hypothesis is that the combination regimen of low-dose radiotherapy, sintilimab and temozolomide is safe and feasible in the treatment of recurrent glioblastoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of low-dose radiation therapy, sintilimab (an immunotherapy checkpoint inhibitor), and temozolomide (a chemotherapy drug) for patients with glioblastoma — the most aggressive form of brain cancer — that has come back after initial treatment. **You may be eligible if...** - You are 18 or older with a confirmed glioblastoma recurrence (by imaging or biopsy) - It has been at least 12 weeks since your last course of radiation therapy - Your general health score (Karnofsky) is 60 or above - Your expected survival is more than 3 months - Your blood counts, kidney, and liver function are within acceptable ranges **You may NOT be eligible if...** - You require high-dose corticosteroids (more than 10 mg prednisone per day) - You have another active cancer in the past 5 years (with limited exceptions) - You have uncontrolled heart disease (heart failure NYHA class II or above, unstable angina, recent heart attack) - You have an active autoimmune disease (e.g., autoimmune colitis, hepatitis, lung inflammation) - You have HIV, or a history of immunodeficiency Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSintilimab

Sintilimab 200mg D1, Q3W

RADIATIONLow-dose Radiotherapy

Radiotherapy 1Gy/1F, D1/D2/D8/D15, Q3W


Locations(1)

Yingpeng Peng

Zhuhai, Guangdong, China

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NCT06220552


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