NCT06468254招募中2 期
An Exploratory Clinical Study of Statins for Improving Chemotherapy and Maintenance in Patients With Ovarian Cancer: a Prospective, Multicenter Clinical Study
Anhui Provincial Cancer Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This study aims to evaluate the effect of statins combined with conventional chemotherapy and maintenance therapy on the prognosis of ovarian cancer patients, exploring its potential to improve survival rates and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must provide written informed consent before any trial procedures commence. The consent form must be documented and retained at the research center.
- •Female patients aged 18 years and older.
- •Patients diagnosed with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (collectively referred to as ovarian cancer) through open surgery, laparoscopic surgery, or core needle biopsy confirmed by pathology.
- •Patients who will require neoadjuvant chemotherapy followed by direct surgery, or direct surgical chemotherapy.
- •Liver Function:
- •Total bilirubin ≤1.5 times the upper limit of normal (ULN) or direct bilirubin ≤1.0 times ULN;
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN. In cases of liver metastases, AST and ALT must be ≤5 times ULN.
- •Kidney Function: Serum creatinine ≤1.5 times ULN, or creatinine clearance rate ≥60 mL/min (calculated using the Cockcroft-Gault formula).
- •Participants must be able to understand the trial procedures and be capable of adhering to the trial protocol for the duration of the study. This includes the ability to complete any required treatments, examinations, tests, follow-up appointments, and questionnaires associated with the trial.
排除标准
- •Are using other investigational drugs or participating in other clinical drug trials simultaneously;
- •Have used or are currently using any medications that interact with statins;
- •Have active cirrhosis, uncontrolled concurrent diseases, a history of chronic myopathy, active hepatitis, or unexplained persistent elevation of serum aminotransferases;
- •Are known to be allergic to statins, or any active or inactive components of drugs with similar chemical structures;
- •Are unable to swallow oral medications or have any gastrointestinal disorders that might interfere with the absorption and metabolism of the study drugs, such as uncontrolled nausea and vomiting, gastrointestinal obstruction, or malabsorption;
- •Require treatment for symptomatic or uncontrolled brain metastases, including but not limited to surgery, radiation, and/or corticosteroids, or have clinical signs of spinal cord compression;
- •Have severe, uncontrolled diseases or conditions that, in the investigator's judgment, make the participant unsuitable for the study. These include but are not limited to:
- •Active viral infections such as HIV, hepatitis B, or hepatitis C.
- •Severe cardiovascular diseases, including uncontrolled ventricular arrhythmias or a recent (within the last 3 months) myocardial infarction.
- •Uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorders affecting the ability to provide informed consent.
- •Uncontrolled hypertension not managed by medication. Immune deficiencies (excluding splenectomy) or other conditions deemed by the investigator to pose a high risk of toxicity.
- •Have any medical history or existing clinical evidence indicating the potential to confound study results, interfere with adherence to the trial protocol throughout the study, or not align with the patient's best interests;
- •Have a history of or current evidence of other malignancies;
- •Are pregnant, breastfeeding, or planning to become pregnant during the study period.
研究组 & 干预措施
Statin Group
Experimental
Statins, 40 mg daily for 1 year or with dosage adjusted based on patient tolerance
干预措施: Statin (Drug)
Control Group
Placebo Comparator
Sugar pill daily for 1 year
干预措施: Sugar pill (Drug)
结局指标
主要结局
Progression free survival
时间窗: 12-month
The time between the start of the trial and tumor progression (in any way) or death (from any cause)
Disease free survival
时间窗: 12-month
Time from surgical resection to local recurrence
次要结局
- Changes of tumor marker CA125(12-month)
- Lipid change(12-month)
- Changes of tumor marker HE4(12-month)
研究者
Bai-Rong Xia
Chairman of Department of Gynaecology Surgery
Anhui Provincial Cancer Hospital
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Livalo Acute Myocardial Infarction StudyAcute Myocardial InfarctionNCT00805714JW Pharmaceutical1,128
终止
4 期
Statins for Prevention of Disease Progression and Hospitalization in Liver CirrhosisLiver CirrhosesNCT04072601Copenhagen University Hospital, Hvidovre78
Unknown
3 期
The Clinical Effect of Intensive Statin Therapy in STEMI Patients Before Emergency PCIST-elevation Myocardial Infarction(STEMI)NCT01334671General Hospital of Chinese Armed Police Forces150
Unknown
4 期
Intensive Statin Therapy in PCI Patient With Acute Coronary SyndromeMyocardial InfarctionUnstable AnginaNCT01372839Xijing Hospital300
已完成
不适用
Statins Study in Kawasaki Disease Children With Coronary Artery AbnormalitiesKawasaki DiseaseCoronary Artery AbnormalitiesNCT03915795Children's Hospital of Fudan University30