Gastrointestinal TumorsPhase 2NCT06775080
The Use of Propranolol in the Perioperative Period of Resectable Gastrointestinal Tumors
A Phase 2 study testing propranolol (beta-blocker used treat high blood pressure) in people with Gastrointestinal Tumors, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastrointestinal Tumors
- What is being tested?
- propranolol (beta-blocker used treat high blood pressure)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 30 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1) 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Wanwei Zheng, 13816431448, calebzww@yeah.net
About this study
Official title: The Use of Propranolol in the Perioperative Period of Resectable Gastrointestinal Tumors and the Study of Its Immune Mechanism Research
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.
- Conditions
- Gastrointestinal Tumors
- Being tested
- propranolol (beta-blocker used treat high blood pressure)
- Medical subject headings
- Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranolol (beta-blocker used treat high blood pressure)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| propranolol (beta-blocker used treat high blood pressure)+surgeries | Experimental | Not described Receives: Drug: propranolol (beta-blocker used treat high blood pressure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Depression Scale Scores
Hamilton Anxiety Scale. The higher the score, the worse the symptoms.
Measured: Within two years of enrollment
heart rate
Sympathetic nervous system activation index
Measured: From enrollment to 24 days postoperatively
Heart rate variability
Sympathetic nervous system activation index
Measured: From enrollment to 24 days postoperatively
blood preasure
Sympathetic nervous system activation index
Measured: From enrollment to 24 days postoperatively
Norepinephrine levels
Sympathetic nervous system activation index
Measured: From enrollment to 24 days postoperatively
blood glucose
Sympathetic nervous system activation index
Measured: From enrollment to 24 days postoperatively
SaO2
Sympathetic nervous system activation index
Measured: From enrollment to 24 days postoperatively
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.).
Measured: Baseline and during surgery
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.).
Measured: Baseline and during surgery
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.
Measured: Baseline and during surgery
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.
Measured: Baseline and during surgery
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.
Measured: Baseline and during surgery
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.
Measured: Baseline and during surgery
Secondary outcomes (2)
2-year OS rate
Measured: Two years after surgery
2-year RFS rate
Measured: Two years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal TumorsStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongguang Luo, MD, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775080
- Sponsor's protocol ID
- KY2024-1317
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Propranolol in the Perioperative Period of Resectable Gastrointestinal Tumors and the Study of Its Immune Mechanism Research
- ClinicalTrials.gov ID
- NCT06775080
- Acronym / sponsor ID
- KY2024-1317
- Conditions
- Gastrointestinal Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| propranolol (beta-blocker used treat high blood pressure)+surgeries | Experimental | Drug: propranolol (beta-blocker used treat high blood pressure) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 1) 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | propranolol (beta-blocker used treat high blood pressure)+surgeries |
Primary outcome
Anxiety Depression Scale Scores
Time frame: Within two years of enrollment
Hamilton Anxiety Scale. The higher the score, the worse the symptoms.
heart rate
Time frame: From enrollment to 24 days postoperatively
Sympathetic nervous system activation index
Heart rate variability
Time frame: From enrollment to 24 days postoperatively
Sympathetic nervous system activation index
blood preasure
Time frame: From enrollment to 24 days postoperatively
Sympathetic nervous system activation index
Norepinephrine levels
Time frame: From enrollment to 24 days postoperatively
Sympathetic nervous system activation index
blood glucose
Time frame: From enrollment to 24 days postoperatively
Sympathetic nervous system activation index
SaO2
Time frame: From enrollment to 24 days postoperatively
Sympathetic nervous system activation index
RNA-seq of tumor tissue
Time frame: Baseline and during surgery
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.).
RNA-seq of peripheral blood PBMCs
Time frame: Baseline and during surgery
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.).
Flow cytometry of peripheral blood PBMC
Time frame: Baseline and during surgery
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.
Flow cytometry of tumor tissues
Time frame: Baseline and during surgery
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.
ELISA detection of tumor tissue
Time frame: Baseline and during surgery
Tumor tissues were examined using ELISA to explore functional changes in specific immune cell subsets before and after preoperative propranolol treatment.
ELISA detection of peripheral blood PBMCs
Time frame: Baseline and during surgery
Functional changes in specific immune cell subsets before and after preoperative propranolol treatment were explored using ELISA for peripheral blood PBMC.
2 secondary outcomes
2-year OS rate
Time frame: Two years after surgery
2-year RFS rate
Time frame: Two years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing propranolol (beta-blocker used treat high blood pressure) in people with Gastrointestinal Tumors, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Depression Scale Scores (time frame: Within two years of enrollment). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.