Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma Following Local Ablation

Inclusion Criteria:

1. 18 years ≤ Age ≤ 75 years, both male and female

2. Patients are diagnosed with HCC via examination of tissues according to Guidelinesfor Diagnosis and Treatment of Hepatocellular Carcinoma (Version 2017) by NHFPC (National Health and Family Planning Commission of the People's Republic of China)and/or HCC imaging criteria of American Association for the Study of Liver Diseases (AASLD) for the diagnosis of HCC;

3. Radiographic testing shows cancer cells have been eliminated after four weeks ofLocal Ablation;Complete Response (CR): Dynamic contrast-enhanced CT scans andfollow-up MR images show low-density area of Hepatocellular Carcinoma and noenhancement during the arterial phase of contrast-enhanced CT; also patients with 0.5-1 cm beyond the limits of the tumor margins (considered as safe surgicalmargins) are eligible;

4. According to contrast-enhanced CT and MRI, with solitary tumor smaller than 5 cm indiameter; with multiple tumors (no more than 3 masses), the largest dimension isless than 3 cm;

5. Patients are eligible if Hemoglobin (Hb) count ≥90g/L, platelets count (PLT) ≥60×109/L, absolute neutrophil count (ANC) count >1.0×109/L, prothrombin activity (PTA)>50%, serum creatinine is less than 1.5 times ULN (Upper Limit of Normal) andtotal bilirubin (TBIL) <51.3μmol/L (3 mg/dL);

6. ECOG score of 0-1;

7. Liver function is Child - Pugh grade A or B.

8. History of TACE for treatment of HCC is less than or equal to twice -

9. The patients are volunteered for the study, sign informed consent form and cooperatewith Investigator to collect data.

Exclusion Criteria:

1. Radiographic testing shows cancer cells have not been eliminated after four weeks ofLocal Ablation;

2. The occurrence of embolism occurs in large blood vessels on liver, patients withextrahepatic metastatic of HCC or liver transplantation;

3. Patients who are about to receive or already received chemotherapy or moleculartargeted therapy;

4. Patients who are about to receive TACE treatment for HCC;

5. Patients without previous treatment of Huaier granules.

6. History of diabetes;

7. HCC patients with uncontrollable ascites at the beginning of enrollment of the studyor are very likely to have ascites during the next four weeks at the time ofenrollment; patients with hepatic encephalopathy or upper gastrointestinal bleeding;

8. Patients have basic diseases including severe cardiopulmonary insufficiency, renalinsufficiency, or severe mental illness;

9. Patients with other infectious disease (excluding viral hepatitis)

10. Patients who cannot take oral medication;

11. Conditions that are considered not suitable for this study investigators.