NCT06327451

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

Recruiting now Phase 2 Last updated 25 March 2024

What this trial tests

Phase 2 trial testing Atorvastatin 20mg in Glioblastoma, IDH-wildtype in 50 participants. Currently enrolling.

Timeline

1 April 2024

Primary endpoint
28 February 2026

28 February 2027

Quick facts

Lead sponsor	Tianjin Medical University General Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 April 2024
Primary completion	28 February 2026
Estimated completion	28 February 2027
Sites	1 location across China

Drugs / interventions tested

• Atorvastatin 20mg — full drug profile →

Conditions studied

• Glioblastoma, IDH-wildtype — all drugs for Glioblastoma, IDH-wildtype →

Sponsor

Tianjin Medical University General Hospital

Who can join

Adults 18 to 60, any sex, with Glioblastoma, IDH-wildtype. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lipid metabolism in cancer cells: Its role in hepatocellular carcinoma progression and therapeutic resistance.
   Wong TL, Kong Y, Ma S. · · 2025 · cited 2× · PMID 41118283 · DOI 10.1097/hc9.0000000000000837
2. Cut the fat: targeting cholesterol and lipid metabolism in glioblastoma.
   Zekanovic S, Achaiber Sing P, Leenstra S, Lamfers MLM. · · 2025 · cited 1× · PMID 41057350 · DOI 10.1038/s41419-025-07993-3
3. Repurposing neurological drugs for brain cancer therapeutics: A systematic approach to identify charged molecules for affinity-based local drug delivery systems.
   Sarker S, Newland B. · · 2025 · cited 1× · PMID 40651674 · DOI 10.1016/j.ijpharm.2025.125935
4. The Mevalonate Pathway in the Radiation Response of Cancer.
   Azizi L, Hausman H, Meyer AK, Wong M, et al · · 2025 · cited 1× · PMID 40194746 · DOI 10.1016/j.ijrobp.2025.03.059