Statin With Palliative Therapy for HCC

April 18, 2017 updated by: Taipei Medical University WanFang Hospital
Statin is a preventive medicine for hepatitis B and hepatitis C which decreases the risk turning into liver cancer,however, the investigators also discovered that patients taking Statin live longer than patients who didn't take Statin in the incidence of liver cancer death cases.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Most liver cancer patients did not accept the cure as the main objective of the treatment after diagnosis because they choose alternative therapies palliative based, such as hepatic arterial chemoembolization, chemotherapy and radiation therapy.

Statin is a preventive medicine for hepatitis B and hepatitis C which decreases the risk turning into liver cancer, yet the clinical effect for Statin is still unknown.

In a previous study of 20,220 liver cancer patients in health care database, the investigators discovered that patients taking Statin live longer than patients who didn't take Statin in the incidence of liver cancer death cases.

This study is a continuation of previous health insurance database studies for clinical trials to verify whether Statin could prolong disease-free survival role for palliative treatment of liver cancer.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Taiwan
      • Taipei, Taiwan, 116
        • WanFangHospital

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

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. >20 years old.
  2. BCLC stage B , stage C and stage D

Exclusion Criteria:

  1. Cancer diagnosis before HCC was confirmed and incurable.
  2. <20 years old, > 90years old.
  3. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Statin(Crestor) taken
Subjects take Statin(Crestor) 10mg per day for a- year
Drug: Statin
Divide HCC patients into two groups under randomization, one is with Statin and the other is without Statin to verify whether Statin could prolong disease-free survival
No Intervention: non Statin(Crestor) taken
non Statin(Crestor) taken as a reference for experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Up to two year
Up to two year

Collaborators and Investigators

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

Sponsor

Taipei Medical University WanFang Hospital

Investigators

  • Study Chair: Ming Shun Wu, Doctor, WanFangHospital

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 (Actual)

September 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

May 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 19, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • N201603038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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