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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01936233
Recruitment Status : Unknown
Verified August 2013 by Zheng-Gang Ren, Fudan University.
Recruitment status was:  Recruiting
First Posted : September 6, 2013
Last Update Posted : September 6, 2013
Information provided by (Responsible Party):
Zheng-Gang Ren, Fudan University

September 2, 2013
September 6, 2013
September 6, 2013
August 2013
October 2015   (Final data collection date for primary outcome measure)
recurrence free survival [ Time Frame: 36 months ]
Same as current
No Changes Posted
  • overall survival [ Time Frame: 36 months ]
  • adverse events [ Time Frame: 36 months ]
Same as current
Not Provided
Not Provided
Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery
Not Provided
Sustained chronic hepatitis B virus inflammation is a major cause of liver cancer occurrence and development. Antiviral treatment can block the persistent infection. Aspirin can inhibit platelet function and CD8 + T cell mediated liver cell necrosis and inflammation. Aspirin also can inhibit liver cancer cells metastasis through inhibit COX2.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hepatocellular Carcinoma
  • Recurrence
  • Drug: Aspirin
    Aspirin 0.1 QD po
  • Drug: Lamivudine
    LAminvudine 0.1 QD po
  • Experimental: Aspirin AND Lamivudine
    • Drug: Aspirin
    • Drug: Lamivudine
  • Active Comparator: Lamivudine
    Intervention: Drug: Lamivudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Zheng-Gang Ren, Fudan University
Fudan University
Not Provided
Not Provided
Fudan University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP