Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy

A Multicenter, Randomized, Paralleled Control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy

To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and metastasis of hepatocarcinoma after radical hepatectomy.

A Multicenter, Randomized, Paralleled control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma after Radical Hepatectomy,to evaluate the efficacy and safety.

Inclusion Criteria:

• Age: ≥ 18 and ≤ 75 years, both male and female;
• Radical hepatectomy has been performed for hepatocellular carcinoma;
• The hepatocellular carcinoma has been confirmed by pathological examination;
• Barcelona clinic liver cancer(BCLC) stage A or B;
• Not receiving any preoperative anticancer drug;
• The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase(AST), glutamic-oxalacetic transaminase(ALT)<3 upper limit of normal(ULN), total bilirubin≤2ULN, serum creatinine <1.5 ULN;
• Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): Hb≥9g/dl, platelet count≥60×109/L, absolute neutrophil count>1.0×109/L;
• The expected survival time ≥ 12 weeks;
• The subjects volunteer to sign the informed consent.

Exclusion Criteria:

• Hepatocellular carcinoma patients who received non-radical hepatectomy;
• Non-hepatocellular carcinoma patients;
• Those with Child-Pugh C;
• Pregnant or lactating women;
• Those with active bleeding due to various reasons;
• Those with HIV infection or AIDS-associated diseases;
• Those with severe acute and chronic diseases;
• Those with severe diabetes;
• Those with serious infectious diseases;
• Those who can not take drugs by oral route;
• Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
• Conditions that are considered not suitable for this study investigators