Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-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:
NCT01760616
First received: January 1, 2013
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-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 Prospective, Multicenter, Open-labeled, Parallel -Controlled Clinical Study Investigating Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Time to significant progression after surgery [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Time to significant progression after surgery, including recurrence of local tumor, intrahepatic and extrahepatic metastasis, etc; and to evaluation of postoperative survival period.


Secondary Outcome Measures:
  • ECOG and QLQ-C30 scores [ Time Frame: Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144 ] [ Designated as safety issue: Yes ]
    On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, assess the scores of Eastern Cooperative Oncology Group(ECOG) and quality of life questionnaire(QLQ)-C30 scale.

  • Iconography assessment [ Time Frame: Week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144 ] [ Designated as safety issue: Yes ]
    On week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, give examination of B ultrasonic for Liver, X-ray for chest. If there is a suspected recurrence or metastases, will give enhancement CT/MRI examination for liver and chest; if no recurrence or metastases, will at least give enhancement CT/MRI examination for liver and chest every year.

  • Alpha-fetoprotein quantitation and related biochemical indicators [ Time Frame: Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144 ] [ Designated as safety issue: Yes ]
    On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, monitor Alpha-fetoprotein quantitation.


Estimated Enrollment: 1680
Study Start Date: August 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test group
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
Drug: Huaier Granule
Huaier Granule is a Chinese medicine, specifications: 20g / bag, manufacturer: Qidong Gaitianli Medicines Co., Ltd..
No Intervention: Control group: adjuvant therapy
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01760616

Locations
China, Hubei
Tongji Hospital Affiliated to Tongji Medical College, Huazhong
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: NCT01760616     History of Changes
Other Study ID Numbers: HE-201102
Study First Received: January 1, 2013
Last Updated: January 3, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Qidong Gaitianli Medicines Co., Ltd:
Huaier Granule;
After non-radical hepatectomy;
Prevention of Disease Progression of Hepatocarcinoma;
Safety.

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

ClinicalTrials.gov processed this record on October 20, 2014