NCT03245554Unknown早期 1 期
Clinical Research on Teratment of Gastrointestinal Cancer in the Preoperative by Propranolol
Central South University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Tumor size will be measured.
研究概览
简要总结
To research the effect of propranolol on the proliferation and apoptosis of gastrointestinal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with gastric adenocarcinoma and colon cancer were diagnosed by histology and cytology, and there was a clear metastasis (TxNxM0);
- •without any prior treatment (including surgery or radiotherapy and chemotherapy) in the I-III period, no distant metastasis, suitable for patients with surgical resection of the tumor.
- •the age range of the patients is 18-60;
- •systolic pressure 100-140mmHg; heart rate >60bpm;
- •the patient's survival time should be longer than 3 months;
- •without previous cardiovascular and cerebrovascular diseases, the atrioventricular block was excluded by the 24 hour dynamic electrocardiogram;
- •ECOG score of 2 (that means the patient's bed time is less than 50%); Karnofsky score of 60% (that means patients have the basic activities and self-care ability);
- •the basic biochemical examination results of patients with normal: white blood cell 3000/ul; neutrophil 1500/ul 100000/ul; platelet count; total bilirubin < 1.5 x ULN; AST / ALT 2.5 x ULN without liver metastasis; < 5 x ULN liver metastasis; creatinine clearance rate of 1.5 x ULN;
- •have the ability to understand and sign informed consent.
排除标准
- •pregnant or lactating women;
- •patients with severe heart disease, kidney disease, metabolic disorders, bronchial asthma, cardiogenic shock, heart block (II-III degree atrioventricular block), or severe acute heart failure, sinus bradycardia.
- •patients with epilepsy or psychotropic drugs and sedatives;
- •patients with brain metastasis and bone marrow metastasis;
- •participants in clinical trials of other drugs within 4 weeks;
- •patients with a history of anaphylaxis with propranolol;
- •patients treated with trastuzumab;
- •patients with or reactive immunodeficiency, such as those with HIV infection;
- •the uncontrollable situation in the group during the period (but not limited to these cases): according to the experimental scheme of medication, severe infection, due to mental illness or other social factors lead to the compliance requirements of patients;
- •patients with atrioventricular block should be discontinued immediately and quit;
- •the researchers believe there may be any increase in the risk of the subject or any interference with clinical trials.
研究组 & 干预措施
placebo and propranolol
Experimental
We used propranolol and placebo as an control drug to treat with patients.
干预措施: Propranolol (Drug)
结局指标
主要结局
Tumor size will be measured.
时间窗: Our experiment completed after patients took medicine for one week.
We used CT and Ki67 to confirm that the drug's affection.
次要结局
未报告次要终点
研究者
Yijing He
Associate Professor
Central South University
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Clinical Study of Propranolol Combined With Neoadjuvant Chemotherapy in Gastric CancerGastric CancerNCT04005365Yijing He78
已完成
不适用
Risk of Cancer Among Pantoprazole UsersEsophagitisNCT01322633Pfizer61,864
已完成
2 期
Safety and Efficacy of Propranolol in Newborns With Retinopathy of PrematurityRetinopathy of PrematurityNCT01079715Azienda Ospedaliero, Universitaria Meyer52
已完成
2 期
Study of 5-Fluorouracil and Leucovorin and Intra-abdominal Floxuridine Chemoradiation in Patients With Fully Resected Locally Advanced Gastric AdenocarcinomaGastric AdenocarcinomaGastric CancerNCT00183911University of Southern California25
终止
2 期
Propranolol Dose Escalation in Lymphedema in PatientsPrimary LymphedemaNCT02595996Columbia University1