Title

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
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Intervention/Treatment

    huaier ...
  • Study Participants

    1044
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.
Study Started
Aug 31
2011
Primary Completion
Aug 31
2016
Study Completion
Aug 31
2016
Results Posted
Oct 02
2017
Last Update
Oct 02
2017

Drug Huaier Granule

Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.

  • Other names: Huaier

Huaier Granule group Experimental

Huaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd.. Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule.

Bank-control group No Intervention

Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents. During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles.

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

Summary

Huaier Granule Group

Bank-control Group

All Events

Event Type Organ System Event Term Huaier Granule Group Bank-control Group

Incidence of Recurrence and Metastasis After Hepatectomy

At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.

Huaier Granule Group

Bank-control Group

Postoperative Survival Period

Assess Postoperative survival period

Bank-control Group

68.5
weeks (Median)
Standard Error: 1.89

Huaier Granule Group

75.5
weeks (Median)
Standard Error: 1.15

Total

1002
Participants

Age, Categorical

Number of tumor

Region of Enrollment

Sex: Female, Male

Overall Study

Huaier Granule Group

Bank-control Group