Glioblastoma, IDH-wildtypePhase 2NCT06327451
Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma
A Phase 2 study testing Atorvastatin 20mg in people with Glioblastoma, IDH-wildtype, run by Tianjin Medical University General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Glioblastoma, IDH-wildtype
- What is being tested?
- Atorvastatin 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 28 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- allergy to atorvastatin or its components;
- concomitant use of clarithromycin, itraconazole, ritonavir, saquinavir, lopinavir, cyclosporine, rifampicin, efavirenz, digoxin, warfarin, oral contraceptives;
- other tumors (except glioma), hematological diseases or other known multiple organ failure, history of myasthenia gravis, heart failure, cerebral hernia and other serious complications;
- History of cardiac insufficiency, arrhythmia, retinopathy, acute hepatic porphyrin, hepatic and renal insufficiency, obesity, uncontrolled diabetes and other metabolic diseases;
- abnormal liver function or liver disease, including uncontrolled hepatitis;
- other diseases that might interfere with the study, as determined by 2 attending neurosurgeons;
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- patients enrolled in a clinical trial within the past 4 weeks;
- pregnant or lactating patients;
- patients with poor compliance who could not complete the treatment;
- other conditions that made the patient ineligible for enrollment as determined by the study investigator;
- patients with a history of HIV and/or HBV/HCV or presence of HIV/HCV;
- patients with a history of tuberculosis or known existence of tuberculosis;
- patients with severe infection or signs/symptoms of infection within 2 weeks before the first dose of study drug;
- patients who received live attenuated vaccine within 4 weeks before the first dose of study drug;
- patients with previous solid organ transplantation or hematopoietic stem cell transplantation.
- Those who meet any of the above criteria will not be selected.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, 300052
Chunsheng Kang, +8602260817499, kang97061@tmu.edu.cn
Xiaoteng Cui, +8602260817481, xiaotengcui@tmu.edu.cn
About this study
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.
- Conditions
- Glioblastoma, IDH-wildtype
- Being tested
- Atorvastatin 20mg
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 20mgDrug
Liptor is a capsule in the form of 20 mg, once daily.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin administrating group | Experimental | 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. Receives: Drug: Atorvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
progression-free survival
Measured: the time from the start of GBM surgery to tumor progression (recurrence) or death, whichever came first, assessed up to 52 weeks
Overall survival
Overall survival
Measured: the time from the start of GBM surgery to the day of death from any cause, whichever came first, assessed up to 52 weeks
Tumor control rate
Tumor control rate
Measured: Changes in tumor size before and after treatment, assessed up to 52 weeks
Secondary outcomes (2)
Hepatic burden of GBM patients after receiving atorvastatin administration
This outcome is evaluation of hepatic burden of GBM patients after receiving atorvastatin administration. Since participant is enrolled in this research, peripheral blood will be collected for testing ALT, AST, GGT, ALP, TP, ALB, GLB, A/G, TBIL, DBIL, and IBIL. The physiological parameters of these index are as follows: ALT: 0~40 U/L; AST: 0~40 U/L; GGT: 0~40 U/L; ALP: 40~110 U/L; TP: 65~85 g/L; ALB: 40~55 g/L; GLB: 20~40 g/L; A/G: 1.5~2.5: 1; TBIL: 0~23 μmol/L; DBIL: 0~8 μmol/L; IBIL: 1~14 μmol/L.
Measured: 1, 3, and 6 months after enrollment
Percentage of participants with treatment-related adverse events
This outcome is evaluation of safety and tolerability during combination therapy of atorvastatin and STUPP protocol. Percentage of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: 1, 3, and 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma, IDH-wildtypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunsheng Kang, Tianjin Medical University General Hospital
- Investigators
- Chunsheng Kang, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327451
- Sponsor's protocol ID
- IRB2024-YX-037-01
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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 other treatments.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma
- ClinicalTrials.gov ID
- NCT06327451
- Acronym / sponsor ID
- IRB2024-YX-037-01
- Conditions
- Glioblastoma, IDH-wildtype
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin administrating group | Experimental | Drug: Atorvastatin 20mgAccording 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (16 listed)
- allergy to atorvastatin or its components;
- concomitant use of clarithromycin, itraconazole, ritonavir, saquinavir, lopinavir, cyclosporine, rifampicin, efavirenz, digoxin, warfarin, oral contraceptives;
- other tumors (except glioma), hematological diseases or other known multiple organ failure, history of myasthenia gravis, heart failure, cerebral hernia and other serious complications;
- History of cardiac insufficiency, arrhythmia, retinopathy, acute hepatic porphyrin, hepatic and renal insufficiency, obesity, uncontrolled diabetes and other metabolic diseases;
- abnormal liver function or liver disease, including uncontrolled hepatitis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 20mgLiptor is a capsule in the form of 20 mg, once daily. | Drug | Atorvastatin administrating group |
Primary outcome
progression-free survival
Time frame: the time from the start of GBM surgery to tumor progression (recurrence) or death, whichever came first, assessed up to 52 weeks
progression-free survival
Overall survival
Time frame: the time from the start of GBM surgery to the day of death from any cause, whichever came first, assessed up to 52 weeks
Overall survival
Tumor control rate
Time frame: Changes in tumor size before and after treatment, assessed up to 52 weeks
Tumor control rate
2 secondary outcomes
Hepatic burden of GBM patients after receiving atorvastatin administration
Time frame: 1, 3, and 6 months after enrollment
Percentage of participants with treatment-related adverse events
Time frame: 1, 3, and 6 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No. 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 other treatments.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chunsheng Kang principal investigator
Tianjin Medical University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin 20mg in people with Glioblastoma, IDH-wildtype, run by Tianjin Medical University General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunsheng Kang (+8618622998838, kang97061@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: the time from the start of GBM surgery to tumor progression (recurrence) or death, whichever came first, assessed up to 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.