Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery
Primary Purpose
Hepatocellular Carcinoma, Recurrence
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Aspirin
Lamivudine
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Aspirin, antiviral treatment, recurrence free survival, radical therapy
Eligibility 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
Sites / Locations
- Liver Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aspirin AND Lamivudine
Lamivudine
Arm Description
Outcomes
Primary Outcome Measures
recurrence free survival
Secondary Outcome Measures
overall survival
adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01936233
Brief Title
Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery
Official Title
Liver Cancer Institiute ,Fudan University
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Recruiting
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation the Treatment Outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Recurrence
Keywords
Hepatocellular Carcinoma, Aspirin, antiviral treatment, recurrence free survival, radical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aspirin AND Lamivudine
Arm Type
Experimental
Arm Title
Lamivudine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin 0.1 QD po
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Description
LAminvudine 0.1 QD po
Primary Outcome Measure Information:
Title
recurrence free survival
Time Frame
36 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
36 months
Title
adverse events
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zheng-Gang Ren, Ph.D
Phone
0086-021-64041990
Ext
2149
Email
ren.zhenggang@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lan Zhang, Ph.D
Phone
0086-021-64041990
Ext
2971
Email
zhang.lan@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenggang Ren, Ph.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liver Cancer Institute
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng-Gang Ren, Ph.D
Phone
0086-021-64041990
Ext
2149
Email
ren.zhenggang@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Lan Zhang, Master
Phone
0086-021-64041990
Ext
2971
Email
zhang.lan@zs-hospital.sh.cn
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery
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