Trial Outcomes & Findings for Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy (NCT NCT01770431)
NCT ID: NCT01770431
Last Updated: 2017-10-02
Results Overview
At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1044 participants
Primary outcome timeframe
Week 94 after took medicine
Results posted on
2017-10-02
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 milestones
| Measure |
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.
Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
|
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.
Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
|
|---|---|---|
|
Overall Study
STARTED
|
696
|
348
|
|
Overall Study
COMPLETED
|
686
|
316
|
|
Overall Study
NOT COMPLETED
|
10
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
Baseline characteristics by cohort
| Measure |
Huaier Granule Group
n=686 Participants
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.
Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
|
Bank-control Group
n=316 Participants
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.
Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
|
Total
n=1002 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
573 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
848 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
113 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
565 Participants
n=5 Participants
|
255 Participants
n=7 Participants
|
820 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
686 Participants
n=5 Participants
|
316 Participants
n=7 Participants
|
1002 Participants
n=5 Participants
|
|
Number of tumor
Single tumor
|
595 Participants
n=5 Participants
|
274 Participants
n=7 Participants
|
869 Participants
n=5 Participants
|
|
Number of tumor
Multiple tumors
|
91 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 94 after took medicineAt week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.
Outcome measures
| Measure |
Huaier Granule Group
n=686 Participants
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.
Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
|
Bank-control Group
n=316 Participants
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.
Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
|
|---|---|---|
|
Incidence of Recurrence and Metastasis After Hepatectomy
Recurrence-free
|
428 Participants
|
155 Participants
|
|
Incidence of Recurrence and Metastasis After Hepatectomy
Recurrence
|
258 Participants
|
161 Participants
|
SECONDARY outcome
Timeframe: Week 94 after took medicineAssess Postoperative survival period
Outcome measures
| Measure |
Huaier Granule Group
n=686 Participants
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.
Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
|
Bank-control Group
n=316 Participants
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.
Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
|
|---|---|---|
|
Postoperative Survival Period
|
75.5 weeks
Standard Error 1.15
|
68.5 weeks
Standard Error 1.89
|
Adverse Events
Huaier Granule Group
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Bank-control Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Huaier Granule Group
n=686 participants at risk
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.
Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
|
Bank-control Group
n=316 participants at risk
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.
Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
|
|---|---|---|
|
Product Issues
Diarrhea
|
5.1%
35/686 • Number of events 175
|
1.9%
6/316 • Number of events 72
|
Additional Information
Xiaoping Chen, Professor
Huazhong University of Science and Technology, Tongji Hospital Affiliated to Tongji Medical College, Huazhong Wuhan, Hubei, China
Phone: +86 27 83663400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60