Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Glioblastoma (GBM) is the primary intracranial malignant tumor with the highest morbidity and mortality, and the 5-year survival rate is less than 10%. The number of primary diagnostic patients and deaths of GBM in China ranks first in the world every year, which seriously threatens people's life and health. At present, the clinical treatment strategy of maximum surgical resection combined with concurrent chemo- and radio-therapy and TTF treatment is still not satisfactory, and the median survival time of GBM patients is only 14.4 months. Statins inhibit cholesterol production with few side effects and are widely used for cholesterol control in patients with hyperlipidemia. In recent years, statins have shown good anti-tumor effect. Our previous study found that statins can block the malignant progression of glioma mediated by EGFR pathway. Therefore, the investigators report a clinical study protocol designed to evaluate the clinical efficacy of a comprehensive treatment strategy of atorvastatin (ATO) combined with temozolomide (TMZ) in primary and recurrent glioblastomas with high EGFR expression. The investigators designed a multicenter, single-arm, double-blind, phase II clinical trial to evaluate the efficacy and safety of oral ATO combined with TMZ in EGFR-high expressing GBM. After informed consent was signed by the patient or authorized family members, the patients were treated with the current STUPP regimen and ATO (20mg, qn) orally. The patients were regularly followed up for 52 weeks after treatment. The primary endpoint was progression-free survival (PFS), which was defined as the time from the start of GBM surgery to tumor progression (recurrence) or death. The secondary end point was the rate of tumor control, which was defined as the proportion of patients with a complete response, a partial response, or a stable disease that had shrunk or remained stable for a given period of time. Safety will be assessed during the study by monitoring of regular MRI scans, laboratory tests (liver function, lipid profile, blood routine), electrocardiography, vital signs (blood pressure, pulse, temperature), and weight. The results of this clinical trial will provide key information on whether the oral combination of atorvastatin and temozolomide prolongs PFS in EGFR-high GBM patients with efficacy and safety.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• age ≥18 years old and \< 60 years old, both sexes;

• sufficient evidence of glioma by MRI scan;

• According to the 2021 WHO latest classification, the molecular pathology of postoperative glioma samples was diagnosed as WHO 4 glioblastoma;

• The immunohistochemical results of postoperative glioma samples showed that EGFR score was 3 (standard: 0 was negative, 1-3 was positive);

• normal blood routine and liver function;

• fully understand the nature of the trial and sign the informed consent;

• be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;

• no serious diseases or accidents requiring surgery;

• normal immune function.

Locations
Other Locations
China
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Contact Information
Primary
Chunsheng Kang
kang97061@tmu.edu.cn
+8618622998838
Backup
Xiaoteng Cui
xiaotengcui@tmu.edu.cn
+8613516251495
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 50
Treatments
Experimental: Atorvastatin administrating group
According to the clinical standard dose of lipid-lowering drugs, the subjects were enrolled in this study. After 2 weeks of glioma surgery, one tablet of liptor was taken orally every night on the basis of STUPP protocol.
Sponsors
Leads: Tianjin Medical University General Hospital

This content was sourced from clinicaltrials.gov