The Use of Propranolol in the Perioperative Period of Resectable Gastrointestinal Tumors and the Study of Its Immune Mechanism Research

Huashan Hospital1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2024年12月1日最近更新: 2025年1月14日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方: Huashan Hospital
入组人数: 40
试验地点: 1
主要终点: heart rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In this study, perioperative propranolol β-blockade was administered to patients with surgically resectable primary gastrointestinal tumors to explore the safety, efficacy, and alleviation of perioperative psychological stress. At the same time, a multi-omics study was conducted using clinical samples to explore the activation of anti-tumor immune response and its mechanism.

详细描述

This is a single-center, randomized controlled pilot exploratory clinical study to enroll 20 patients with surgically resectable primary gastric cancer and 20 patients with surgically resectable primary colorectal cancer. Each enrolled patient will be assigned a case number. This case number and the patient's initials will be entered on each page of the case report form. Trial group (10 patients with gastric cancer and 10 patients with intestinal cancer): Enrolled patients will be hospitalized for 10-14 days of preoperative propranolol β-blockade monotherapy prior to surgery (including the day of surgery) for evaluation of efficacy and safety. Control group (10 cases of gastric cancer and 10 cases of intestinal cancer): no propranolol drug treatment. Patients will be observed during the treatment period and at 6 months, 12 months and 24 months after treatment.

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 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Surgically resectable primary gastric cancer and colorectal cancer;
•Age greater than 18 years old and less than 65 years old;
•Negative pregnancy test for women of childbearing age;
•ECOG score ≤2;
•Signed informed consent.
•Resting blood pressure greater than 100/60mmHg, heart rate greater than 60 beats per minute.
•Exclusion Criteria：
•Pregnant or breastfeeding women, or women with pregnancy plans within six months; 2) Patients with absolute or relative contraindications to propranolol:
•Pathological sinus node syndrome;
•Sinus bradycardia (less than 60 beats/minute);
•First, second or third degree AV block;
•Resting blood pressure less than 100/60 mmHg;
•untreated pheochromocytoma;
•untreated thyroid disease;
•Patients on dihydropyridine or non-dihydropyridine calcium channel blockers (e.g., diltiazem, verapamil, nifedipine, amlodipine);
•Severe peripheral vascular disease (intermittent claudication);
•Patients on antiarrhythmic drugs (e.g., amiodarone, sotalol, digoxin);
•Patients with renal insufficiency (defined as creatinine clearance greater than 0.15 mmol/L);
•Patients with hepatic insufficiency: AST or ALT or ALP > 2.5 times the upper limit of normal (ULN), bilirubin > 1.5 times the ULN, ALP > 2.5
•Patients using colistin, digoxin, rizatriptan, cimetidine, hydralazine, guanethidine, or ergotamine.
•Patients with a history of major depressive episodes; 3) Patients who have undergone surgery for GI tumors within the previous six months; 4) Patients receiving neoadjuvant chemotherapy prior to planned gastrointestinal tumor resection; 5) patients using conventional anxiolytic drugs (e.g. benzodiazepines), alpha-adrenergic agonists (e.g. colistin); 6) Patients using selective or non-selective β-adrenergic inhibitors (e.g., propranolol, metoprolol, atenolol, sotalol) within the last three months; 7) Patients with a history of stroke; 8) Patients with moderate or severe asthma, defined as requiring hospitalization or oral steroid therapy; (9) Those who, in the opinion of the physician, have other reasons for not being included in the treatment.

排除标准

未提供

研究组 & 干预措施

propranolol (beta-blocker used treat high blood pressure)+surgeries

Experimental

干预措施: propranolol (beta-blocker used treat high blood pressure) (Drug)