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

Hepatocellular Carcinoma Clinical Trial

Official title:

Liver Cancer Institiute ,Fudan University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01936233
• Other study ID #: LC-ASPIRIN
• Status: Recruiting
• Phase: Phase 3
• Start date: August 2013
• Est. completion date: December 2023

Study information

• Verified date: December 2018
• Source: Fudan University
• Contact: Zheng-Gang Ren, Ph.D
• Phone: 0086-021-64041990
• Email: ren.zhenggang[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: December 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Neoplasms
• Recurrence

Intervention

Drug:
• Aspirin
Aspirin 0.1 QD po
• Lamivudine
LAminvudine 0.1 QD po

Locations

Country	Name	City	State
China	Liver Cancer Institute	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence free survival		36 months
Secondary	overall survival		36 months
Secondary	adverse events		36 months