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

Primary Purpose

Hepatic Carcinoma

Status
Completed
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 treatment trial for Hepatic Carcinoma focused on measuring Huaier Granule;, After radical hepatectomy;, Prevention of Recurrence and Metastasis;, Safety.

Eligibility Criteria

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

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

Sites / Locations

  • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Huaier Granule group

Bank-control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of Recurrence and Metastasis After Hepatectomy
At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.

Secondary Outcome Measures

Postoperative Survival Period
Assess Postoperative survival period

Full Information

First Posted
January 1, 2013
Last Updated
May 5, 2017
Sponsor
Qidong Gaitianli Medicines Co., Ltd
Collaborators
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01770431
Brief Title
Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
Official Title
A Multicenter, Randomized, Paralleled Control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (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 recurrence and metastasis of hepatocarcinoma after radical hepatectomy.
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.

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 radical hepatectomy;, Prevention of Recurrence and Metastasis;, Safety.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1044 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Huaier Granule group
Arm Type
Experimental
Arm Description
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.
Arm Title
Bank-control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Huaier Granule
Other Intervention Name(s)
Huaier
Intervention Description
Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
Primary Outcome Measure Information:
Title
Incidence of Recurrence and Metastasis After Hepatectomy
Description
At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.
Time Frame
Week 94 after took medicine
Secondary Outcome Measure Information:
Title
Postoperative Survival Period
Description
Assess Postoperative survival period
Time Frame
Week 94 after took medicine

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; 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
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 University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29802174
Citation
Chen Q, Shu C, Laurence AD, Chen Y, Peng BG, Zhen ZJ, Cai JQ, Ding YT, Li LQ, Zhang YB, Zheng QC, Xu GL, Li B, Zhou WP, Cai SW, Wang XY, Wen H, Peng XY, Zhang XW, Dai CL, Bie P, Xing BC, Fu ZR, Liu LX, Mu Y, Zhang L, Zhang QS, Jiang B, Qian HX, Wang YJ, Liu JF, Qin XH, Li Q, Yin P, Zhang ZW, Chen XP. Effect of Huaier granule on recurrence after curative resection of HCC: a multicentre, randomised clinical trial. Gut. 2018 Nov;67(11):2006-2016. doi: 10.1136/gutjnl-2018-315983. Epub 2018 May 25.
Results Reference
derived

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

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