Hepatocellular Carcinoma
Conditions
Interventions
Experimental group:Vitamin D
Control:Placebo
Sponsors
Zhongshan Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Hepatocellular carcinoma was diagnosed clinically or pathologically; 2. After radical ablation (radiofrequency or microwave), imaging examination showed that the lesions were completely ablated one month after operation; patients were randomly divided into two groups within 12 weeks after radical ablation. 3. High risk recurrence: single lesion >2cm, =18 years; 9. Patients with chronic hepatitis B virus (HBV) infection, whose HBV-DNA is less than 500 IU / ml, and whose hepatitis B surface antigen is positive, must receive antiviral treatment according to the treatment guidelines; patients with hepatitis C (HCV-RNA positive) must receive antiviral treatment according to the treatment guidelines, and their liver function is at CTCAE level 1; 10. Women and men of childbearing age should agree to take birth control measures from the time of signing informed consent. 11. Good organ and bone marrow function of the patients: (1) Hemoglobin concentration >=90 g/L; (2) Neutrophil count > 1.5 x 10*9/L; (3) Platelet count >=75 x 10*9/L; (4) Total bilirubin concentration =29 g/L; (6) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 50 ml/min; (9) Urinary protein =2 +, 24-hour urinary protein < 1.0 g); (10) The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Five or more tumor lesions; 2. There were high vitamin D, hypercalcemia or hyperphosphatemia; 3. Cholangiocarcinoma or mixed cell carcinoma, or combined with other tumors; 4. Uncontrollable infection; 5. Renal failure; 6. Hyperparathyroidism; 7. History of drug allergy; 8. HIV infection; 9. Pregnancy or lactation; 10. Within the first 30 days, patients with severe bleeding symptoms or with clear gastrointestinal bleeding tendency (fecal occult blood + + and above are not allowed to be included). (1) Arrhythmias with grade II or above myocardial ischemia or infarction and poor control (including QTc interval >=450 ms in male and >=470 ms in female); (2) The left ventricular ejection fraction (LVEF) was less than 50% according to NYHA grade III-IV cardiac insufficiency or visceral color Doppler ultrasound; (3) had a history of hepatic encephalopathy; (4) Active hepatitis without treatment (HBsAg positive and HBV-DNA = 500 IU / ml; hepatitis C: HCV-RNA positive and liver function abnormal; combined with hepatitis B and hepatitis C co-infection; (5) After liver transplantation; (6) has received cancer treatment in the past; (7) Evidence of portal vein thrombosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence-free survival, RFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;TTR;Change of liver function;Safety;Quality of life;Biomarker; | — |
Countries
China
Contacts
Public ContactChen Rongxin
Zhongshan Hospital of Fudan University
Outcome results
None listed