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

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Hepatocellular Carcinoma; Recurrence

Treatments: Drug: Aspirin; Drug: Lamivudine

Study type: Interventional

Funder types: Other

Identifiers

NCT01936233

LC-ASPIRIN

Details and patient eligibility

About

Evaluation the Treatment Outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Aspirin AND Lamivudine

Experimental group

Treatment:

Drug: Aspirin

Drug: Lamivudine

Lamivudine

Active Comparator group

Treatment:

Drug: Lamivudine