Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery
NCT ID: NCT01936233
Last Updated: 2019-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
112 participants
INTERVENTIONAL
2013-08-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aspirin AND Lamivudine
Aspirin
Aspirin 0.1 QD po
Lamivudine
LAminvudine 0.1 QD po
Lamivudine
Lamivudine
LAminvudine 0.1 QD po
Interventions
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Aspirin
Aspirin 0.1 QD po
Lamivudine
LAminvudine 0.1 QD po
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zheng-Gang Ren
chief of departement
Principal Investigators
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Zhenggang Ren, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Liver Cancer Institute
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LC-ASPIRIN
Identifier Type: -
Identifier Source: org_study_id
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