Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
|ClinicalTrials.gov Identifier: NCT01770431|
Recruitment Status : Completed
First Posted : January 17, 2013
Results First Posted : October 2, 2017
Last Update Posted : October 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatic Carcinoma||Drug: Huaier Granule||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1044 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomized, Paralleled Control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
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
Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
Other Name: Huaier
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.
- Incidence of Recurrence and Metastasis After Hepatectomy [ Time Frame: Week 94 after took medicine ]At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.
- Postoperative Survival Period [ Time Frame: Week 94 after took medicine ]Assess Postoperative survival period
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770431
|Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology|
|Wuhan, Hubei, China|
|Principal Investigator:||Xiaoping Chen, Professor||Huazhong University of Science and Technology|