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

Phase 3

• Conditions: Hepatocellular Carcinoma; Recurrence
• Interventions: Drug: Lamivudine; Drug: Aspirin

• Registration Number: NCT01936233
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-05
• Study First Posted: 2013-09-06
• Status Verified: 2018-12
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-05
• Primary Completion: 2021-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lamivudine	Lamivudine	-
Aspirin AND Lamivudine	Aspirin	-
Aspirin AND Lamivudine	Lamivudine	-

Primary Outcome Measures

Name	Time	Method
recurrence free survival	36 months

Secondary Outcome Measures

Name	Time	Method
overall survival	36 months
adverse events	36 months

Trial Locations

Locations (1)

Liver Cancer Institute; 🇨🇳 Shanghai, Shanghai, China