Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery

Study Overview
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Brief Summary
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Evaluation the Treatment Outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.

Detailed Description
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The investigators conduct this clinical trial to evaluate the treatment outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.The primary outcome is overall survival and objective response rate.

Official Title
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Liver Cancer Institiute ,Fudan University

Conditions
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Hepatocellular Carcinoma, Recurrence

Intervention / Treatment
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* Drug: Aspirin
* Drug: Lamivudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features Age ≥ 18 years and ≤ 75 years At least one tumor nodule with one uni-dimension of ≥ 2 cm Child-Pugh Class A or B HBV-DNA>10^4 Total bilirubin ≤ 1.5 x upper limit of normal ALT and AST ≤ 2.0 x the upper limit of normal PT-INR<2.3,PTT < 1.5 x upper limit of normal Serum creatinine ≤ 1.5x upper limit of normal Peripheral white blood cell count of or more than 3×10(9)/L Peripheral platelet of or more than 50×10(9)/L Expected survival time not less than 3 months ECOG score 0-2 Exclusion Criteria: Tumor thrombi in main branch of portal vein Tumor involvement more than 70% of whole liver With extrahepatic metastasis Prior systemic chemotherapy or chemoembolization Congestive heart failure > NYHA class 2 History of HIV infection Active clinically serious infections (> 2 NCI-CTC Version 3.0) Recurrence of HCC after liver transplantation Pregnant or breast-feeding Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study Known or suspected allergy to any agent given in association with this trial Patients unable to swallow oral medication Inclined to thrombosis Inclined to hemorrhage or active hemorrhage with 1 month

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin AND Lamivudine<br> | Drug: Aspirin<br>* Aspirin 0.1 QD po<br>Drug: Lamivudine<br>* LAminvudine 0.1 QD po<br>|
| Active Comparator: Lamivudine<br> | Drug: Lamivudine<br>* LAminvudine 0.1 QD po<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence free survival |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 36 months | 
| adverse events |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, Aspirin, antiviral treatment, recurrence free survival, radical therapy