Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-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 disease progression of hepatocarcinoma after non-radical hepatectomy.

Detailed Description
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A Prospective, Multicenter, Open-labeled, Parallel -controlled Clinical Study, to evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.

Official Title
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A Prospective, Multicenter, Open-labeled, Parallel -Controlled Clinical Study Investigating Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-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; Non-radical hepatectomy has been performed for hepatocellular carcinoma; The hepatocellular carcinoma has been confirmed by pathological examination; 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 ≤2 ULN, 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, neutrophil count> 1.5×109/L; The expected survival time ≥12 weeks; The subjects volunteer to sign the informed consent. Exclusion Criteria: Non-hepatocellular carcinoma patients; Those who received radical hepatectomy; Those with hepatic decompensation; Pregnant or lactating women; Those with HIV infection or AIDS-associated diseases; Those with severe acute and chronic diseases, such as infection, diabetes cardiac insufficiency, pulmonary insufficiency, renal insufficiency; Those who can not take drugs by oral route; or those develop serious adverse drug reaction; 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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Test group: Adjuvant therapy + Huaier Granule group.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 144 weeks after surgery or until study termination Adjuvant therapy: the adjuvant therapies are not limited, and for example, all the following treatments can be applied according to the individual's condition and guidelines of the research center: ablation therapy, immunotherapy, chemotherapy, radiotherapy, and Chinese herbs, as well as programs and medications that are used for post-operative liver protection and antiviral treatment | Drug: Huaier Granule<br>* Huaier Granule is a Chinese medicine, specifications: 20g / bag, manufacturer: Qidong Gaitianli Medicines Co., Ltd..<br>|
| No Intervention: Control group: adjuvant therapy<br>Control group: adjuvant therapy Adjuvant therapy: the adjuvant therapies are not limited, and for example, all the following treatments can be applied according to the individual's condition and guidelines of the research center: ablation therapy, immunotherapy, chemotherapy, radiotherapy, and Chinese herbs, as well as programs and medications that are used for post-operative liver protection and antiviral treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to significant progression after surgery and postoperative survival period. | Time to significant progression after surgery, including recurrence of local tumor, intrahepatic and extrahepatic metastasis, etc; and to evaluation of postoperative survival period. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECOG and QLQ-C30 scores | On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, assess the scores of Eastern Cooperative Oncology Group(ECOG) and quality of life questionnaire(QLQ)-C30 scale. | Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144 | 
| Iconography assessment | On week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, give examination of B ultrasonic for Liver, X-ray for chest. If there is a suspected recurrence or metastases, will give enhancement CT/MRI examination for liver and chest; if no recurrence or metastases, will at least give enhancement CT/MRI examination for liver and chest every year. | Week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144 | 
| Alpha-fetoprotein quantitation and related biochemical indicators | On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, monitor Alpha-fetoprotein quantitation. | Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Huaier Granule;, After non-radical hepatectomy;, Prevention of Disease Progression of Hepatocarcinoma;, Safety.