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A Multicenter, Randomized, Paralleled Control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy


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

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Trial Information

A Multicenter, Randomized, Paralleled Control Clinical Study Investigating 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.


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

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:

Incidence and occurrence time of recurrence and metastasis after hepatectomy

Outcome Description:

At week 6 after took medicine, assess incidence and occurrence time of recurrence and metastasis after hepatectomy.

Outcome Time Frame:

Week 6 after took medicine

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-201101

NCT ID:

NCT01770431

Start Date:

August 2011

Completion Date:

December 2014

Related Keywords:

  • Hepatic Carcinoma;
  • Huaier Granule;
  • After radical hepatectomy;
  • Prevention of Recurrence and Metastasis;
  • Safety.
  • Carcinoma
  • Neoplasm Metastasis
  • Recurrence
  • Carcinoma, Hepatocellular

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