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

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

Detailed Description
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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.

Official Title
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A Multicenter, Randomized, Paralleled Control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy

Conditions
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Hepatic Carcinoma

Intervention / Treatment
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* Drug: Huaier Granule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Huaier Granule group<br>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<br>* Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.<br>* Other names: Huaier;|
| No Intervention: Bank-control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Recurrence and Metastasis After Hepatectomy | At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy. | Week 94 after took medicine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Survival Period | Assess Postoperative survival period | Week 94 after took medicine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Huaier Granule;, After radical hepatectomy;, Prevention of Recurrence and Metastasis;, Safety.