Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery
Liver Cancer Institiute ,Fudan University
1 other identifier
interventional
112
1 country
1
Brief Summary
Evaluation the Treatment Outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hepatocellular-carcinoma
Started Aug 2013
Longer than P75 for phase_3 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 2, 2013
CompletedFirst Posted
Study publicly available on registry
September 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedAugust 5, 2019
December 1, 2018
8.3 years
September 2, 2013
August 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recurrence free survival
36 months
Secondary Outcomes (2)
overall survival
36 months
adverse events
36 months
Study Arms (2)
Aspirin AND Lamivudine
EXPERIMENTALLamivudine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Liver Cancer Institute
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhenggang Ren, Ph.D
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief of departement
Study Record Dates
First Submitted
September 2, 2013
First Posted
September 6, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2021
Study Completion
December 1, 2023
Last Updated
August 5, 2019
Record last verified: 2018-12