Hepatocellular Carcinoma, Recurrence
Conditions
Keywords
Hepatocellular Carcinoma, Aspirin, antiviral treatment, recurrence free survival, radical therapy
Brief summary
Evaluation the Treatment Outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.
Detailed description
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.
Interventions
DRUGAspirin
Aspirin 0.1 QD po
DRUGLamivudine
LAminvudine 0.1 QD po
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence free survival | 36 months |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | 36 months |
| adverse events | 36 months |
Countries
China
Contacts
Primary ContactZheng-Gang Ren, Ph.D
Backup ContactLan Zhang, Ph.D
Outcome results
None listed