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


Phase 4
18 Years
75 Years
Open (Enrolling by invite only)
Both
Hepatic Carcinoma

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Trial Information

A Prospective, Multicenter, Open-labeled, Parallel -Controlled Clinical Study Investigating 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.


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> 2.5×109/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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to significant progression after surgery

Outcome Description:

Time to significant progression after surgery, including recurrence of local tumor, intrahepatic and extrahepatic metastasis, etc; and to evaluation of postoperative survival period.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Xiaoping Chen, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huazhong University of Science and Technology

Authority:

China: Food and Drug Administration

Study ID:

HE-201102

NCT ID:

NCT01760616

Start Date:

August 2011

Completion Date:

December 2015

Related Keywords:

  • Hepatic Carcinoma
  • Huaier Granule;
  • After non-radical hepatectomy;
  • Prevention of Disease Progression of Hepatocarcinoma;
  • Safety.
  • Carcinoma
  • Disease Progression
  • Carcinoma, Hepatocellular

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