NCT06775080 The Use of Propranolol in the Perioperative Period of Resectable Gastrointestinal Tumors
| NCT ID | NCT06775080 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Huashan Hospital |
| Condition | Gastrointestinal Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2024-12-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT06775080 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Gastrointestinal Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06775080 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06775080 currently recruiting?
Yes, NCT06775080 is actively recruiting participants. Visit ClinicalTrials.gov or contact Huashan Hospital to inquire about joining.
Where is the NCT06775080 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06775080 clinical trial?
NCT06775080 is sponsored by Huashan Hospital. The trial plans to enroll 40 participants.