Statin With Palliative Therapy for HCC

Sponsor

Taipei Medical University WanFang Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT02785874

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HCC	Drug: Statin	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Statin With Palliative Therapy for HCC

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Overall Survival [Up to two year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

20 years old.
BCLC stage B , stage C and stage D

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	WanFangHospital	Taipei		Taiwan	116

Sponsors and Collaborators

Taipei Medical University WanFang Hospital

Investigators

Study Chair: Ming Shun Wu, Doctor, WanFangHospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taipei Medical University WanFang Hospital

ClinicalTrials.gov Identifier:

NCT02785874

Other Study ID Numbers:

N201603038

First Posted:

May 30, 2016

Last Update Posted:

Apr 19, 2017

Last Verified:

May 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Apr 19, 2017