Could a $4 statin improve cancer survival?
NCT ID NCT07625930
First seen Jun 25, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This phase II trial tests whether adding simvastatin, a widely used cholesterol medication, to standard chemotherapy (with or without immunotherapy) can improve outcomes for people with gastroesophageal adenocarcinoma. About 184 patients will be randomly assigned to receive either standard treatment alone or standard treatment plus daily simvastatin for up to two years. The main goal is to see if the tumor responds better to treatment before surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- simvastatin
- What this could lead to
- If successful, adding a common, cheap cholesterol drug could improve survival and tumor response for people with gastroesophageal cancer.
- What could go wrong
- This is a small, early-phase trial (184 patients) testing a repurposed drug. The benefit is uncertain, and there may be added side effects from combining simvastatin with chemotherapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 184 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Apr 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed, informed consent. 2. Age, 18 years or older. 3. Histological diagnosis of adenocarcinoma or poorly differentiated carcinoma of the esophagus or EGJ. 4. The tumour must be deemed potentially resectable by the surgical team. This assessment is based on complete staging imaging studies (detailed below) - clinical staging of the tumor and ruling out metastatic disease. 5. Locally advanced disease as defined per AJCC/UICC 8th edition37: stage IIA, IIB, III, IVA (T1-4a N2-3). 6. Eligibility for standard-of-care perioperative systemic therapy with FLOT+/-D. 7. Life expectancy greater than 3 months. 8. ECOG performance status \< 2. Exclusion Criteria: 1. Prior esophageal or gastric malignancy. 2. History of allergic reactions to simvastatin or atorvastatin or similar chemical or biological compounds. 3. Ongoing cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors), in which case the patient is offered enrollment in the observational arm. 4. Hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range) or renal dysfunction (creatinine level more than three times the upper limit of the normal range). 5. Predisposing factors for rhabdomyolysis: hypothyroidism, reduced renal function, muscle disease, or excessive alcohol consumption AND creatine kinase up to less than five times the upper limit (measured in the presence of predisposing factors). 6. Concurrent medication with potent CYP3A4-inhibitors, e.g. ketokonazole, erythromycin, gemfibrozil, cyclosporine, or danazol. 7. Pre-existing medical conditions precluding treatment, including any contraindication systemic chemotherapy or major surgery. 8. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, discussed before registration in the trial. 9. Pregnant and breastfeeding women. 10. Unwillingness to undergo per-protocol investigations or treatments.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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McGill University Health Center
Montreal, Canada
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Other studies related to the condition(s) this trial covers.
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