Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy

• Status: Terminated
• Trial end date: 2017-06-30
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-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:

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

2. Non-radical hepatectomy has been performed for hepatocellular carcinoma;

3. The hepatocellular carcinoma has been confirmed by pathological examination;

4. 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 ≤2 ULN, serum creatinine <1.5 ULN;

5. Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): Hb≥9g/dl, platelet count≥60×109/L, neutrophil count> 1.5×109/L;

6. The expected survival time ≥12 weeks;

7. The subjects volunteer to sign the informed consent.

Exclusion Criteria:

1. Non-hepatocellular carcinoma patients;

2. Those who received radical hepatectomy;

3. Those with hepatic decompensation;

4. Pregnant or lactating women;

5. Those with HIV infection or AIDS-associated diseases;

6. Those with severe acute and chronic diseases, such as infection, diabetes cardiac insufficiency, pulmonary insufficiency, renal insufficiency;

7. Those who can not take drugs by oral route; or those develop serious adverse drug reaction;

8. Drug abusers or those with psychological or mental diseases that may interfere with study compliance;

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