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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Recurrence Drug: Aspirin Drug: Lamivudine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2013
Estimated Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: Aspirin AND Lamivudine Drug: Aspirin
Aspirin 0.1 QD po

Drug: Lamivudine
LAminvudine 0.1 QD po

Active Comparator: Lamivudine Drug: Lamivudine
LAminvudine 0.1 QD po

Primary Outcome Measures :
  1. recurrence free survival [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 36 months ]
  2. adverse events [ Time Frame: 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01936233

Contact: Zheng-Gang Ren, Ph.D 0086-021-64041990 ext 2149
Contact: Lan Zhang, MD 0086-021-64041990 ext 2971

China, Shanghai
Liver Cancer Institute Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zheng-Gang Ren, Ph.D    0086-021-64041990 ext 2149   
Contact: Lan Zhang, Master    0086-021-64041990 ext 2971   
Sponsors and Collaborators
Fudan University

Responsible Party: Zheng-Gang Ren, chief of departement, Fudan University Identifier: NCT01936233     History of Changes
Other Study ID Numbers: LC-ASPIRIN
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: September 6, 2013
Last Verified: August 2013

Keywords provided by Zheng-Gang Ren, Fudan University:
Hepatocellular Carcinoma
antiviral treatment
recurrence free survival
radical therapy

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors