RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial (RESTAGE)
2026年7月8日 更新者：Lorenzo Ferri、McGill University Health Centre/Research Institute of the McGill University Health Centre
RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial: A Phase II Randomized Open-Label Trial of Perioperative Simvastatin Plus Standard-of-Care Systemic Therapy in Gastroesophageal Adenocarcinoma
Esophageal and gastroesophageal junction cancers are serious diseases with limited cure rates, even when patients receive chemotherapy and surgery. New ways to improve treatment are urgently needed.
This study will test whether adding a commonly used cholesterol-lowering medication, simvastatin, to standard cancer treatment can improve outcomes. Simvastatin is widely used, safe, and inexpensive. Research suggests that it may also slow cancer growth by blocking pathways that cancer cells rely on for survival.
In this trial, patients will receive standard chemotherapy (with or without immunotherapy) before surgery. Half of the patients will also take simvastatin daily for up to two years. Researchers will compare how well tumors respond to treatment and whether patients remain cancer-free longer.
If successful, this approach could offer a simple and accessible way to improve survival for patients with these cancers without adding significant side effects or cost.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
184
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Lorenzo Edwin Ferri, MD, PhD
- 电话号码：42835 514-934-1934
- 邮箱：lorenzo.ferri@mcgill.ca
学习地点
-
-
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Montreal、加拿大
- McGill University Health Center
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接触：
- Lorenzo Edwin Ferri, MD, PhD
- 电话号码：42835 514-934-1934
- 邮箱：lorenzo.ferri@mcgill.ca
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Signed, informed consent.
- Age, 18 years or older.
- Histological diagnosis of adenocarcinoma or poorly differentiated carcinoma of the esophagus or EGJ.
- 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.
- Locally advanced disease as defined per AJCC/UICC 8th edition37: stage IIA, IIB, III, IVA (T1-4a N2-3).
- Eligibility for standard-of-care perioperative systemic therapy with FLOT+/-D.
- Life expectancy greater than 3 months.
- ECOG performance status < 2.
Exclusion Criteria:
- Prior esophageal or gastric malignancy.
- History of allergic reactions to simvastatin or atorvastatin or similar chemical or biological compounds.
- Ongoing cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors), in which case the patient is offered enrollment in the observational arm.
- 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).
- 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).
- Concurrent medication with potent CYP3A4-inhibitors, e.g. ketokonazole, erythromycin, gemfibrozil, cyclosporine, or danazol.
- Pre-existing medical conditions precluding treatment, including any contraindication systemic chemotherapy or major surgery.
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, discussed before registration in the trial.
- Pregnant and breastfeeding women.
- Unwillingness to undergo per-protocol investigations or treatments.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Control
SOC neoadjuvant FLOT (or FLOT-D)
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Standard of care neoadjuvant FLOT
Standard of care Durvalumab added to FLOT regimen.
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实验性的：Experimental
SOC neoadjuvant FLOT (or FLOT-D) + simvastatin
|
Standard of care neoadjuvant FLOT
Standard of care Durvalumab added to FLOT regimen.
Investigational drug added to standard of care FLOT or FLOT+D
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
MPR
大体时间：From enrolment to surgical pathology assessment, 16 weeks
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Major Pathological Response
|
From enrolment to surgical pathology assessment, 16 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Statin-enhanced toxicity of standard-of-care regimen, specifically grade 3 or 4 adverse events
大体时间：Start of neoadjuvant therapy to the end of adjuvant therapy (weeks 2-28)
|
Statin-enhanced toxicity of standard-of-care regimen, specifically grade 3 or 4 adverse events, as per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, warranting dosage modification or stoppage of interventional drug or chemotherapy.
CTCAE grading is from 1 to 5, while grade 1 is the least severe (mild) and grade 5 is the most severe (death).
|
Start of neoadjuvant therapy to the end of adjuvant therapy (weeks 2-28)
|
|
2-year EFS
大体时间：Elapsed time from date of randomization to date of recurrence or death, within 2 years from resection
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2-year event-free-survival (EFS), defined as elapsed time from date of randomization to date of recurrence (local or distant) or death, occurring after resection
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Elapsed time from date of randomization to date of recurrence or death, within 2 years from resection
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2027年1月1日
初级完成 (估计的)
2029年4月1日
研究完成 (估计的)
2031年4月1日
研究注册日期
首次提交
2026年5月29日
首先提交符合 QC 标准的
2026年5月29日
首次发布 (实际的)
2026年6月4日
研究记录更新
最后更新发布 (实际的)
2026年7月10日
上次提交的符合 QC 标准的更新
2026年7月8日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.