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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
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 2, 2013
Last Updated
August 1, 2019
Sponsor
Fudan University
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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

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

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