Not yet recruiting
May 7, 2019
May 7, 2019
The purpose of this study is to evaluate the efficacy and safety of arginine in preventing cancer development
Cancer is considered to be the leading cause of death among non-infectious diseases and the most important obstacle to increase life expectancy for every country in the 21st century. However, even if various interventions such as embolization chemotherapy, systemic chemotherapy, radiofrequency ablation, and targeted therapy are widely used in clinical practice, the improvement of patients' survival is still limited. Our previous study found that arginine hydrochloride could significantly promote the apoptosis of liver cancer cells, and inhibit the progression of HCC by prompting the urea cycle. Therefore, our research group has carried out this study to evaluate the efficacy of arginine in preventing cancers.
Based on the routine treatment for underlying diseases, subjects were administrated by arginine.
Drug: Arginine hydrochloride
Arginine hydrochloride injection 5g/dose; 40g/d; ivgtt; sustained medication for 24 days; drug withdrawal for 4 days. Treatment is continued until the levels of tumor marker dropped to normal
- 1. Ages 40-75 years 2. 2 ULN of tumor markers (CEA, AFP, ca-125, ca19-9, NSE, HCG and
cyfra21-1) 3. No space-occupying lesions were found by the current imaging examination
4. The major organ function is normal that is meeting the following standards: Blood
routine examination: (No blood transfusion, no G-CSF and no medication were corrected
within 14 days before screening) a.HB≥80g/L； b.ANC≥1.5×109/L；c.PLT≥50×109/L;
Biochemical examination: (ALB was not transfused within 14 days before screening) a.
ALB ≥29 g/L； b.ALT and AST140 mmHg, diastolic pressure>90 mmHg) 5.
Patients with myocardial ischemia or myocardial infarction over grade II or a poorly
controlled arrhythmia (including QTc interval: men ≥450 ms; women ≥470 ms) 6.Cardiac
functional insufficiency of grade III to IV according to NYHA standard;
echocardiography: LVEF<50% 7. Patients with severe organ damage and less than 3 years expected survival time 8. Pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptives 9. Patients with mental sickness or the history of psychotropic drug abuse 10. Patients with severe infection (unable to control the infection effectively) 11. The researchers believe that any other factors unsuitable for entering into the study.