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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Huazhong University of Science and Technology
Information provided by (Responsible Party):
Qidong Gaitianli Medicines Co., Ltd
ClinicalTrials.gov Identifier:
NCT01770431
First received: January 1, 2013
Last updated: January 20, 2013
Last verified: January 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence and occurrence time of recurrence and metastasis after hepatectomy [ Time Frame: Week 6 after took medicine ] [ Designated as safety issue: Yes ]
    At week 6 after took medicine, assess incidence and occurrence time of recurrence and metastasis after hepatectomy.

  • Incidence and occurrence time of recurrence and metastasis after hepatectomy [ Time Frame: Week 14 after took medicine ] [ Designated as safety issue: Yes ]
    At week 14 after took medicine, assess incidence and occurrence time of recurrence and metastasis after hepatectomy.

  • Incidence and occurrence time of recurrence and metastasis after hepatectomy [ Time Frame: Week 22 after took medicine ] [ Designated as safety issue: Yes ]
    At week 22 after took medicine, assess incidence and occurrence time of recurrence and metastasis after hepatectomy.

  • Incidence and occurrence time of recurrence and metastasis after hepatectomy [ Time Frame: Week 34 after took medicine ] [ Designated as safety issue: Yes ]
    At week 34 after took medicine, assess incidence and occurrence time of recurrence and metastasis after hepatectomy.

  • Incidence and occurrence time of recurrence and metastasis after hepatectomy [ Time Frame: Week 46 after took medicine ] [ Designated as safety issue: Yes ]
    At week 46 after took medicine, assess incidence and occurrence time of recurrence and metastasis after hepatectomy.

  • Incidence and occurrence time of recurrence and metastasis after hepatectomy [ Time Frame: Week 58 after took medicine ] [ Designated as safety issue: Yes ]
    At week 58 after took medicine, assess incidence and occurrence time of recurrence and metastasis after hepatectomy.

  • Incidence and occurrence time of recurrence and metastasis after hepatectomy [ Time Frame: Week 70 after took medicine ] [ Designated as safety issue: Yes ]
    At week 70 after took medicine, assess incidence and occurrence time of recurrence and metastasis after hepatectomy.

  • Incidence and occurrence time of recurrence and metastasis after hepatectomy [ Time Frame: Week 82 after took medicine ] [ Designated as safety issue: Yes ]
    At week 82 after took medicine, assess incidence and occurrence time of recurrence and metastasis after hepatectomy.

  • Incidence and occurrence time of recurrence and metastasis after hepatectomy [ Time Frame: Week 94 after took medicine ] [ Designated as safety issue: Yes ]
    At week 94 after took medicine, assess incidence and occurrence time of recurrence and metastasis after hepatectomy.


Secondary Outcome Measures:
  • Postoperative survival period [ Time Frame: Week 6,14,22,34,46,58,70,82,94 after took medicine ] [ Designated as safety issue: Yes ]
    Assess Postoperative survival period; Eastern Cooperative Oncology Group(ECOG) and quality of life questionnaire(QLQ)-C30 scores;Imaging assessment;Alpha-fetoprotein quantitation and related biochemical indicators, etc at week 6,14,22,34,46,58,70,82,94 after took medicine.


Estimated Enrollment: 1080
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (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
Placebo Comparator: 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.

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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Qidong Gaitianli Medicines Co., Ltd
ClinicalTrials.gov Identifier: NCT01770431     History of Changes
Other Study ID Numbers: HE-201101
Study First Received: January 1, 2013
Last Updated: January 20, 2013
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 20, 2014