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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qidong Gaitianli Medicines Co., Ltd
• Collaborator: Huazhong University of Science and Technology

Criteria

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