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RecruitingNCT06775080Updated Jan 14, 2025

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

A Phase 2 interventional study of propranolol (beta-blocker used treat high blood pressure) in Gastrointestinal Tumors, sponsored by Huashan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Huashan Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Gastrointestinal Tumors
03

In context

Digestive System Neoplasms

311 studies on the registry are indexed under Digestive System Neoplasms; 83 are open to participants now.

This study's planned enrollment of 40 is below the median of 50 across 233 interventional studies indexed under Digestive System Neoplasms.

Browse Digestive System Neoplasms studies →

Lead sponsor

Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

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

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

Interventions

  • Drugpropranolol (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

06

What researchers measure

Primary outcomes

  1. Anxiety Depression Scale Scores

    Hamilton Anxiety Scale. The higher the score, the worse the symptoms.

    Time frame: Within two years of enrollment

  2. heart rate

    Sympathetic nervous system activation index

    Time frame: From enrollment to 24 days postoperatively

  3. Heart rate variability

    Sympathetic nervous system activation index

    Time frame: From enrollment to 24 days postoperatively

  4. blood preasure

    Sympathetic nervous system activation index

    Time frame: From enrollment to 24 days postoperatively

  5. Norepinephrine levels

    Sympathetic nervous system activation index

    Time frame: From enrollment to 24 days postoperatively

  6. blood glucose

    Sympathetic nervous system activation index

    Time frame: From enrollment to 24 days postoperatively

  7. SaO2

    Sympathetic nervous system activation index

    Time frame: From enrollment to 24 days postoperatively

  8. RNA-seq of tumor tissue

    Tumor tissues were examined by RNA-seq to assess the alteration of tumor microenvironment before and after treatment, and to explore the possible alteration of activation pathways (DAMP, RIG-I, NF-kB, JAK-STAT, etc.).

    Time frame: Baseline and during surgery

  9. RNA-seq of peripheral blood PBMCs

    Peripheral blood PBMCs were examined by RNA-seq to assess the alteration of tumor microenvironment before and after treatment, and to explore the possible alteration of activation pathways (DAMP, RIG-I, NF-kB, JAK-STAT, etc.).

    Time frame: Baseline and during surgery

  10. Flow cytometry of peripheral blood PBMC

    Flow cytometry was applied to the peripheral blood PBMC to assess the changes in the systemic immune system and tumor immune microenvironment before and after treatment, and to explore new subpopulations of immune cells with characteristic alterations.

    Time frame: Baseline and during surgery

  11. Flow cytometry of tumor tissues

    Flow cytometry was applied to the tumor tissues to assess the changes in the systemic immune system and tumor immune microenvironment before and after treatment, and to explore new subpopulations of immune cells with characteristic alterations.

    Time frame: Baseline and during surgery

  12. ELISA detection of tumor tissue

    Tumor tissues were examined using ELISA to explore functional changes in specific immune cell subsets before and after preoperative propranolol treatment.

    Time frame: Baseline and during surgery

  13. ELISA detection of peripheral blood PBMCs

    Functional changes in specific immune cell subsets before and after preoperative propranolol treatment were explored using ELISA for peripheral blood PBMC.

    Time frame: Baseline and during surgery

Secondary outcomes

  1. 2-year OS rate

    Time frame: Two years after surgery

  2. 2-year RFS rate

    Time frame: Two years after surgery

07

Study locations

1 of 1 sites recruiting
  • Huashan Hospital, Fudan University
    Shanghai, Shanghai 200040, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06775080
Lead sponsor
Huashan Hospital
Responsible party
Zhongguang Luo, MD (Chief Physician, Huashan Hospital) — Principal investigator
First posted
Jan 14, 2025
Start date
Dec 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Jan 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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