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Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy

Primary Purpose

Hepatic Carcinoma

Status
Terminated
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Huaier Granule
Sponsored by
Qidong Gaitianli Medicines Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatic Carcinoma focused on measuring Huaier Granule;, After non-radical hepatectomy;, Prevention of Disease Progression of Hepatocarcinoma;, Safety.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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> 1.5×109/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.

Sites / Locations

  • Tongji Hospital Affiliated to Tongji Medical College, Huazhong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Test group

Control group: adjuvant therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Time to significant progression after surgery and postoperative survival period.
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
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
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
On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, monitor Alpha-fetoprotein quantitation.

Full Information

First Posted
January 1, 2013
Last Updated
March 5, 2020
Sponsor
Qidong Gaitianli Medicines Co., Ltd
Collaborators
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01760616
Brief Title
Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
difficult to recruit patients
Study Start Date
November 7, 2011 (Actual)
Primary Completion Date
August 15, 2015 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qidong Gaitianli Medicines Co., Ltd
Collaborators
Huazhong University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Carcinoma
Keywords
Huaier Granule;, After non-radical hepatectomy;, Prevention of Disease Progression of Hepatocarcinoma;, Safety.

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
790 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group: adjuvant therapy
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Huaier Granule
Intervention Description
Huaier Granule is a Chinese medicine, specifications: 20g / bag, manufacturer: Qidong Gaitianli Medicines Co., Ltd..
Primary Outcome Measure Information:
Title
Time to significant progression after surgery and postoperative survival period.
Description
Time to significant progression after surgery, including recurrence of local tumor, intrahepatic and extrahepatic metastasis, etc; and to evaluation of postoperative survival period.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
ECOG and QLQ-C30 scores
Description
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.
Time Frame
Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144
Title
Iconography assessment
Description
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.
Time Frame
Week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144
Title
Alpha-fetoprotein quantitation and related biochemical indicators
Description
On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, monitor Alpha-fetoprotein quantitation.
Time Frame
Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: ≥ 18 and ≤ 75 years, both male and female; Non-radical hepatectomy has been performed for hepatocellular carcinoma; The hepatocellular carcinoma has been confirmed by pathological examination; 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; 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> 1.5×109/L; The expected survival time ≥12 weeks; The subjects volunteer to sign the informed consent. Exclusion Criteria: Non-hepatocellular carcinoma patients; Those who received radical hepatectomy; Those with hepatic decompensation; Pregnant or lactating women; Those with HIV infection or AIDS-associated diseases; Those with severe acute and chronic diseases, such as infection, diabetes cardiac insufficiency, pulmonary insufficiency, renal insufficiency; Those who can not take drugs by oral route; or those develop serious adverse drug reaction; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoping Chen, Professor
Organizational Affiliation
Huazhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital Affiliated to Tongji Medical College, Huazhong
City
Wuhan
State/Province
Hubei
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy

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