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Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01770431
First Posted: January 17, 2013
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Huazhong University of Science and Technology
Information provided by (Responsible Party):
Qidong Gaitianli Medicines Co., Ltd
  Purpose
To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and metastasis of hepatocarcinoma after radical hepatectomy.

Condition Intervention Phase
Hepatic Carcinoma Drug: Huaier Granule Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Paralleled Control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy

Further study details as provided by Qidong Gaitianli Medicines Co., Ltd:

Primary Outcome Measures:
  • Incidence of Recurrence and Metastasis After Hepatectomy [ Time Frame: Week 94 after took medicine ]
    At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.


Secondary Outcome Measures:
  • Postoperative Survival Period [ Time Frame: Week 94 after took medicine ]
    Assess Postoperative survival period


Enrollment: 1044
Study Start Date: August 2011
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Huaier Granule group

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.

Drug: Huaier Granule
Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
Other Name: Huaier
No Intervention: Bank-control group

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.


Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770431


Locations
China, Hubei
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Sponsors and Collaborators
Qidong Gaitianli Medicines Co., Ltd
Huazhong University of Science and Technology
Investigators
Principal Investigator: Xiaoping Chen, Professor Huazhong University of Science and Technology
  More Information

Responsible Party: Qidong Gaitianli Medicines Co., Ltd
ClinicalTrials.gov Identifier: NCT01770431     History of Changes
Other Study ID Numbers: HE-201101
First Submitted: January 1, 2013
First Posted: January 17, 2013
Results First Submitted: January 2, 2017
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Qidong Gaitianli Medicines Co., Ltd:
Huaier Granule;
After radical hepatectomy;
Prevention of Recurrence and Metastasis;
Safety.

Additional relevant MeSH terms:
Neoplasm Metastasis
Recurrence
Carcinoma, Hepatocellular
Neoplastic Processes
Neoplasms
Pathologic Processes
Disease Attributes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases