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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Zheng-Gang Ren, Fudan University
ClinicalTrials.gov Identifier:
NCT01936233
First received: September 2, 2013
Last updated: September 5, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Hepatocellular Carcinoma
Recurrence
Drug: Aspirin
Drug: Lamivudine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • recurrence free survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • adverse events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 112
Study Start Date: August 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936233

Contacts
Contact: Zheng-Gang Ren, Ph.D 0086-021-64041990 ext 2149 ren.zhenggang@zs-hospital.sh.cn
Contact: Lan Zhang, MD 0086-021-64041990 ext 2971 zhang.lan@zs-hospital.sh.cn

Locations
China, Shanghai
Liver Cancer Institute Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zheng-Gang Ren, Ph.D    0086-021-64041990 ext 2149    ren.zhenggang@zs-hospital.sh.cn   
Contact: Lan Zhang, Master    0086-021-64041990 ext 2971    zhang.lan@zs-hospital.sh.cn   
Sponsors and Collaborators
Fudan University
  More Information

No publications provided

Responsible Party: Zheng-Gang Ren, chief of departement, Fudan University
ClinicalTrials.gov Identifier: NCT01936233     History of Changes
Other Study ID Numbers: LC-ASPIRIN, ASPIRIN-13-08
Study First Received: September 2, 2013
Last Updated: September 5, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
Hepatocellular Carcinoma
Aspirin
antiviral treatment
recurrence free survival
radical therapy

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Recurrence
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes
Lamivudine
Aspirin
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on October 19, 2014