Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
NCT ID: NCT01770431
Last Updated: 2017-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1044 participants
INTERVENTIONAL
2011-08-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
No interventions assigned to this group
Interventions
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Huaier Granule
Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Huazhong University of Science and Technology
OTHER
Qidong Gaitianli Medicines Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaoping Chen, Professor
Role: PRINCIPAL_INVESTIGATOR
Huazhong University of Science and Technology
Locations
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Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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References
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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.
Other Identifiers
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HE-201101
Identifier Type: -
Identifier Source: org_study_id