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CompletedNCT01770431Updated Oct 2, 2017Results posted

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

A Phase 4 interventional study of Huaier Granule in Hepatic Carcinoma, sponsored by Qidong Gaitianli Medicines Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-02.

Sponsored by Qidong Gaitianli Medicines Co., Ltd · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
1,044
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and metastasis of hepatocarcinoma after radical hepatectomy.

Read the 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.

02

Conditions studied

  • Hepatic Carcinoma

Keywords

  • Huaier Granule;
  • After radical hepatectomy;
  • Prevention of Recurrence and Metastasis;
  • Safety.
03

In context

Neoplasm Metastasis

3,514 studies on the registry are indexed under Neoplasm Metastasis; 883 are open to participants now.

This study's enrollment of 1,044 is above the median of 54 across 2,765 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Qidong Gaitianli Medicines Co., Ltd is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,044 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • DrugHuaier Granule

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

    Also known as: Huaier

06

What researchers measure

Primary outcomes

  1. Incidence of Recurrence and Metastasis After Hepatectomy

    At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.

    Time frame: Week 94 after took medicine

Secondary outcomes

  1. Postoperative Survival Period

    Assess Postoperative survival period

    Time frame: Week 94 after took medicine

07

Results

Posted Oct 2, 2017

Participant flow

Patients were recruited from 39 hospitals in China between December 7, 2011 and December 31, 2014. 1044 patients met eligibility criteria and were randomly assigned at a 2:1 ratio: 696 in Huaier group and 348 patients in the blank control group.

Participant flow — Overall Study
MilestoneHuaier Granule GroupBank-control Group
Started696348
Completed686316
Not completed1032

Outcome measures

PrimaryIncidence of Recurrence and Metastasis After Hepatectomy

At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.

Time frame:
Week 94 after took medicine
Reported as:
Count of participants · Participants
Incidence of Recurrence and Metastasis After Hepatectomy
ParticipantsHuaier Granule GroupBank-control Group
Recurrence-free428155
Recurrence258161
Statistical analysis
  • Huaier Granule Group vs Bank-control Group · Cochran-Mantel-Haenszel · p = 0.0001 · Chi-squared: 14.7315
SecondaryPostoperative Survival Period

Assess Postoperative survival period

Time frame:
Week 94 after took medicine
Reported as:
Median · weeks
Postoperative Survival Period
weeksHuaier Granule GroupBank-control Group
Postoperative Survival Period75.5 ± 1.1568.5 ± 1.89
Statistical analysis
  • Huaier Granule Group vs Bank-control Group · Regression, Cox · p = <0.0001 · Hazard ratio (hr): 0.67 · 95% CI 0.55 to 0.81

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Huaier Granule Group—0/686 (0%)35/686 (5.1%)
Bank-control Group—0/316 (0%)6/316 (1.9%)
Most frequent other events
Most frequent other events
EventHuaier Granule GroupBank-control Group
DiarrheaProduct Issues35/6866/316

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Huaier Granule GroupBank-control GroupTotal
<=18 years000
Between 18 and 65 years573275848
>=65 years11341154
Sex: Female, Male
Sex: Female, Male(Participants)Huaier Granule GroupBank-control GroupTotal
Female12161182
Male565255820
Region of Enrollment
Region of Enrollment(Participants)Huaier Granule GroupBank-control GroupTotal
China6863161002
Number of tumor
Number of tumor(Participants)Huaier Granule GroupBank-control GroupTotal
Single tumor595274869
Multiple tumors9142133
08

Study locations

1 site
  • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei, China
09

References and documents

Publications

  • 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. PubMed 29802174 ↗

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01770431
Lead sponsor
Qidong Gaitianli Medicines Co., Ltd
Collaborators
Huazhong University of Science and Technology
Responsible party
Sponsor
First posted
Jan 17, 2013
Start date
Aug 2011
Primary completion
Aug 2016
Completion
Aug 2016
Results posted
Oct 2, 2017
Last update
Oct 2, 2017

Study contacts

Xiaoping Chen, Professor
principal investigator · Huazhong University of Science and Technology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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