Background Temozolomide is applied as the standard chemotherapy agent in patients with glioblastoma (GBM) after surgery. However, the benefit of this treatment for patients is limited by the invasive growth of gliomas and drug resistance. There are indications from fundamental experimental and retrospective studies that levetiracetam has the potential to improve the survival rate of patients with GBM. However, it has yet to be determined whether the combination of temozolomide and levetiracetam is more effective than standard temozolomide chemotherapy. Therefore, we designed a randomized clinical trial to investigate the therapeutic effect of the new combined regime for treating GBM. Methods/design This is a double-blind and randomized clinical trial conducted in a single center. One hundred forty-two patients will be recruited and screened for the inclusion and exclusion criteria. Then, eligible participants will be randomly assigned to an experimental group or a control group in a 1:1 ratio. Based on the administration of radiation therapy (RT), participants in the experimental group will be prescribed levetiracetam plus temozolomide chemotherapy for 34 weeks while participants in the control group will receive placebo tablets plus temozolomide for the same duration. A 3-year follow-up will be conducted on all patients after intervention. Accordingly, the primary outcome will be progression-free survival (PFS). The secondary endpoints include overall survival (OS), the Karnofsky Performance Status (KPS), the objective response rate (ORR), and adverse event incidence. Discussion It is expected that the results of this trial will provide high-level evidence regarding the clinical benefits of levetiracetam and temozolomide combined in the treatment of GBM. Trial registration Chinese Clinical Trial Registry, ChiCTR2100049941. Registered on 14 August 2021

Aim: Superparamagnetic iron oxide nanoparticles (SPIONs) is a widely used biomedical material for imaging and targeting drug delivery. We synthesized SPIONs and tested their effects on the radiosensitization of glioma.Methods: Acetylated 3-aminopropyltrimethoxysilane (APTS)-coated iron oxide nanoparticles (Fe3O4 NPs) were synthesized via a one-step hydrothermal approach and the surface was chemically modified with acetic anhydride to generate surface charge-neutralized NPs. NPs were characterized by TEM and ICP-AES. Radiosensitivity of U87MG glioma cells was evaluated by MTT assay. Cell cycle and apoptosis in glioma cells were examined by flow cytometry. Results: APTS-coated Fe3O4 NPs had a spherical or quasi-spherical shape with average size of 10.5±1.1 nm. NPs had excellent biocompatibility and intracellular uptake of NPs reached the peak 24 hours after treatment. U87 cell viability decreased significantly after treatment with both X-ray and NPs compared to X-ray treatment alone. Compared to X-ray treatment alone, the percentage of cells in G2/M phase (31.83%) significantly increased in APTS-coated Fe3O4 NPs plus X-ray treated group (P<0.05). In addition, the percentage of apoptotic cells was significant higher in APTS-coated Fe3O4 NPs plus X-ray treated group than in X-ray treatment alone group (P<0.05). Conclusion: APTS-coated Fe3O4 NPs achieved excellent biocompatibility and increased radiosensitivity for glioma cells.