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

August 1, 2019 updated by: Zheng-Gang Ren, Fudan University

Liver Cancer Institiute ,Fudan University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Aspirin AND Lamivudine
Drug: Aspirin
Aspirin 0.1 QD po
Drug: Lamivudine
LAminvudine 0.1 QD po
ACTIVE_COMPARATOR: Lamivudine
Drug: Lamivudine
LAminvudine 0.1 QD po

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
recurrence free survival
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 36 months
36 months
adverse events
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Zhenggang Ren, Ph.D, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

September 2, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (ESTIMATE)

September 6, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC-ASPIRIN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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