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

NCT ID: NCT01936233

Last Updated: 2019-08-05

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2023-12-31

Brief Summary

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Evaluation the Treatment Outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aspirin AND Lamivudine

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Aspirin 0.1 QD po

Lamivudine

Intervention Type DRUG

LAminvudine 0.1 QD po

Lamivudine

Group Type ACTIVE_COMPARATOR

Lamivudine

Intervention Type DRUG

LAminvudine 0.1 QD po

Interventions

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Aspirin

Aspirin 0.1 QD po

Intervention Type DRUG

Lamivudine

LAminvudine 0.1 QD po

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zheng-Gang Ren

chief of departement

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Zheng-Gang Ren, Ph.D

Role: CONTACT

0086-021-64041990 ext. 2149

Lan Zhang, Ph.D

Role: CONTACT

0086-021-64041990 ext. 2971

Facility Contacts

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Zheng-Gang Ren, Ph.D

Role: primary

0086-021-64041990 ext. 2149

Lan Zhang, Master

Role: backup

0086-021-64041990 ext. 2971

Other Identifiers

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LC-ASPIRIN

Identifier Type: -

Identifier Source: org_study_id

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