Statin With Palliative Therapy for HCC | NCT02785874

Studies
Statin With Palliative Therapy for HCC

NCT02785874

Sponsor

Taipei Medical University WanFang Hospital

Status

Terminated

Last Update Posted

Apr 19, 2017Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Interventions

Statin

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient for the fund

Expanded Access Info

Start Date

Sep 1, 2016Actual

Primary Completion Date

Oct 1, 2016Actual

Completion Date

Nov 1, 2016Actual

First Submitted Date

May 25, 2016

First Submission Date that Met QC Criteria

May 27, 2016

First Posted Date

May 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2017

Last Update Posted Date

Apr 19, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Statin(Crestor) taken	Experimental	Subjects take Statin(Crestor) 10mg per day for a- year	Drug: Statin
non Statin(Crestor) taken	No Intervention	non Statin(Crestor) taken as a reference for experimental group.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Statin	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival		Up to two year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ming Shun Wu, Doctor	WanFangHospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
WanFangHospital		Taipei		116	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019161	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Ancestor Terms

ID	Term
D000924	Anticholesteremic Agents
D000960	Hypolipidemic Agents
D000963	Antimetabolites
D045504	Molecular Mechanisms of Pharmacological Action

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Browse Branches

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