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

September 2, 2013
September 5, 2013
August 2013
October 2015   (final data collection date for primary outcome measure)
recurrence free survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01936233 on ClinicalTrials.gov Archive Site
  • overall survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • adverse events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
    Interventions:
    • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
112
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
Both
18 Years to 75 Years
No
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
China
 
NCT01936233
LC-ASPIRIN, ASPIRIN-13-08
Yes
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