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RECRUITING

NCT06775080

PHASE2

The Use of Propranolol in the Perioperative Period of Resectable Gastrointestinal Tumors

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-12-01

Completion Date

2027-04-30

Last Updated

2025-01-14

Healthy Volunteers

Conditions

Gastrointestinal Tumors

Interventions

DRUG

propranolol (beta-blocker used treat high blood pressure)

Enrolled patients began receiving propranolol alone orally twice daily (10 mg bid) 10-14 days prior to surgery, and after 3 days of treatment, the dose of propranolol was increased to 20 mg bid daily until the day of surgery if the following three predefined criteria were met: systolic blood pressure greater than 90 mmHg, heart rate greater than 60 bpm, and no significant symptoms (e.g., syncope, insomnia, fatigue). The patient continues to be treated from 1 week after surgery.From 1 week after surgery, patients continue propranolol for 3 weeks. Patients will be monitored daily for symptoms, blood pressure, and heart rate and will be followed for observation at 6, 12, and 24 months after surgery until disease progression or clinical death, unless intolerable toxicity occurs and the patient refuses to continue treatment. The efficacy and safety of the preoperative propranolol β-blockade regimen in patients with gastrointestinal tract tumors was evaluated using the study objectives in S

Inclusion Criteria: 1. Surgically resectable primary gastric cancer and colorectal cancer; 2. Age greater than 18 years old and less than 65 years old; 3. Negative pregnancy test for women of childbearing age; 4. ECOG score ≤2; 5. Signed informed consent. 6. Resting blood pressure greater than 100/60mmHg, heart rate greater than 60 beats per minute. Exclusion Criteria： 1\) Pregnant or breastfeeding women, or women with pregnancy plans within six months; 2) Patients with absolute or relative contraindications to propranolol: 1. Pathological sinus node syndrome; 2. Sinus bradycardia (less than 60 beats/minute); 3. First, second or third degree AV block; 4. Resting blood pressure less than 100/60 mmHg; 5. untreated pheochromocytoma; 6. untreated thyroid disease; 7. Patients on dihydropyridine or non-dihydropyridine calcium channel blockers (e.g., diltiazem, verapamil, nifedipine, amlodipine); 8. Severe peripheral vascular disease (intermittent claudication); 9. Patients on antiarrhythmic drugs (e.g., amiodarone, sotalol, digoxin); 10. Patients with renal insufficiency (defined as creatinine clearance greater than 0.15 mmol/L); 11. 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 12. Patients using colistin, digoxin, rizatriptan, cimetidine, hydralazine, guanethidine, or ergotamine. 13. 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.

Locations (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China