Clinical Research on Teratment of Gastrointestinal Cancer in the Preoperative by Propranolol

Central South University

Status and phase: Unknown; Early Phase 1

Conditions: Gastrointestinal Cancer

Treatments: Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT03245554

2017 PROP/CSU/GC

Details and patient eligibility

About

To research the effect of propranolol on the proliferation and apoptosis of gastrointestinal cancer.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients with gastric adenocarcinoma and colon cancer were diagnosed by histology and cytology, and there was a clear metastasis (TxNxM0);
2. without any prior treatment (including surgery or radiotherapy and chemotherapy) in the I-III period, no distant metastasis, suitable for patients with surgical resection of the tumor.
3. the age range of the patients is 18-60;
4. systolic pressure 100-140mmHg; heart rate >60bpm;
5. the patient's survival time should be longer than 3 months;
6. without previous cardiovascular and cerebrovascular diseases, the atrioventricular block was excluded by the 24 hour dynamic electrocardiogram;
7. ECOG score of 2 (that means the patient's bed time is less than 50%); Karnofsky score of 60% (that means patients have the basic activities and self-care ability);
8. the basic biochemical examination results of patients with normal: white blood cell 3000/ul; neutrophil 1500/ul 100000/ul; platelet count; total bilirubin < 1.5 x ULN; AST / ALT 2.5 x ULN without liver metastasis; < 5 x ULN liver metastasis; creatinine clearance rate of 1.5 x ULN;
9. have the ability to understand and sign informed consent.

Exclusion criteria

1. pregnant or lactating women;
2. patients with severe heart disease, kidney disease, metabolic disorders, bronchial asthma, cardiogenic shock, heart block (II-III degree atrioventricular block), or severe acute heart failure, sinus bradycardia.
3. patients with epilepsy or psychotropic drugs and sedatives;
4. patients with brain metastasis and bone marrow metastasis;
5. participants in clinical trials of other drugs within 4 weeks;
6. patients with a history of anaphylaxis with propranolol;
7. patients treated with trastuzumab;
8. patients with or reactive immunodeficiency, such as those with HIV infection;
9. the uncontrollable situation in the group during the period (but not limited to these cases): according to the experimental scheme of medication, severe infection, due to mental illness or other social factors lead to the compliance requirements of patients;
10. patients with atrioventricular block should be discontinued immediately and quit;
11. the researchers believe there may be any increase in the risk of the subject or any interference with clinical trials.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

placebo and propranolol

Experimental group

Description:

We used propranolol and placebo as an control drug to treat with patients.

Treatment:

Drug: Propranolol