Status:
UNKNOWN
Clinical Research on Teratment of Gastrointestinal Cancer in the Preoperative by Propranolol
Lead Sponsor:
Central South University
Conditions:
Gastrointestinal Cancer
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief Summary
To research the effect of propranolol on the proliferation and apoptosis of gastrointestinal cancer.
Eligibility Criteria
Inclusion
- patients with gastric adenocarcinoma and colon cancer were diagnosed by histology and cytology, and there was a clear metastasis (TxNxM0);
- 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.
- the age range of the patients is 18-60;
- systolic pressure 100-140mmHg; heart rate \>60bpm;
- the patient's survival time should be longer than 3 months;
- without previous cardiovascular and cerebrovascular diseases, the atrioventricular block was excluded by the 24 hour dynamic electrocardiogram;
- 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);
- 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;
- have the ability to understand and sign informed consent.
Exclusion
- pregnant or lactating women;
- 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.
- patients with epilepsy or psychotropic drugs and sedatives;
- patients with brain metastasis and bone marrow metastasis;
- participants in clinical trials of other drugs within 4 weeks;
- patients with a history of anaphylaxis with propranolol;
- patients treated with trastuzumab;
- patients with or reactive immunodeficiency, such as those with HIV infection;
- 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;
- patients with atrioventricular block should be discontinued immediately and quit;
- the researchers believe there may be any increase in the risk of the subject or any interference with clinical trials.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03245554
Start Date
May 1 2018
End Date
September 1 2020
Last Update
April 9 2018
Active Locations (1)
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1
Institute of Clinical Pharmacology
Changsha, Hunan, China, 410005