Trial | NCT01760616  Report issue

Title

Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy
A Prospective, Multicenter, Open-labeled, Parallel -Controlled Clinical Study Investigating Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    huaier ...

  • Study Participants

    790
To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.
A Prospective, Multicenter, Open-labeled, Parallel -controlled Clinical Study, to evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.
Study Started
Nov 07
2011
Primary Completion
Aug 15
2015
Study Completion
Jun 30
2017
Last Update
Mar 06
2020

Drug Huaier Granule

Huaier Granule is a Chinese medicine, specifications: 20g / bag, manufacturer: Qidong Gaitianli Medicines Co., Ltd..

Test group Experimental

Test group: Adjuvant therapy + Huaier Granule group.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 144 weeks after surgery or until study termination Adjuvant therapy: the adjuvant therapies are not limited, and for example, all the following treatments can be applied according to the individual's condition and guidelines of the research center: ablation therapy, immunotherapy, chemotherapy, radiotherapy, and Chinese herbs, as well as programs and medications that are used for post-operative liver protection and antiviral treatment

Control group: adjuvant therapy No Intervention

Control group: adjuvant therapy Adjuvant therapy: the adjuvant therapies are not limited, and for example, all the following treatments can be applied according to the individual's condition and guidelines of the research center: ablation therapy, immunotherapy, chemotherapy, radiotherapy, and Chinese herbs, as well as programs and medications that are used for post-operative liver protection and antiviral treatment.

Criteria 

Inclusion Criteria:

Age: ≥ 18 and ≤ 75 years, both male and female;
Non-radical hepatectomy has been performed for hepatocellular carcinoma;
The hepatocellular carcinoma has been confirmed by pathological examination;
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;
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;
The expected survival time ≥12 weeks;
The subjects volunteer to sign the informed consent.

Exclusion Criteria:

Non-hepatocellular carcinoma patients;
Those who received radical hepatectomy;
Those with hepatic decompensation;
Pregnant or lactating women;
Those with HIV infection or AIDS-associated diseases;
Those with severe acute and chronic diseases, such as infection, diabetes cardiac insufficiency, pulmonary insufficiency, renal insufficiency;
Those who can not take drugs by oral route; or those develop serious adverse drug reaction;
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.
No Results Posted