The Combination Effect of Statin Plus Metformin on Relapse-free

April 18, 2017 updated by: Taipei Medical University WanFang Hospital
The study demonstrated that either statin or metformin served as notable use in reducing the incidence of many cancers.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study revealed the population-based cohort study investigated the protective effect of statin and metformin against cancer events in patients with HBV infection. The study demonstrated that either statin or metformin served as independent chemopreventive agents with a dose-response effect in reducing the incidence of cancer with a dose-response effect of the agents and an additive or synergistic effect of combining statin and metformin use in reducing the incidence of many cancers.1 And based on our data in animal models, administration of metformin and statin might enhance the therapeutic effect of local tumor through apoptotic and antiangiogenesis pathways. These results also seemed as the synergistic effect of statin and metformin combined use in tumor control.2 The aim of this study is to clarify the potential protective benefit of these drugs on the combination effect of Statin plus Metformin on relapse-free survival of HCC patients after local treatments in patients with HBV.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

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
        • Taipei Medical University - WanFang Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. 20 years or older at the time of obtaining consent. 2. Systemic conditions are 0 to 2 score of Performance Status (according to Eastern Cooperative Oncology Group: ECOG). 3.Diagnosis of hepatocellular carcinoma is based on the following 1) or 2).

    1. Patients who are confirmed to have early tumor stain and typical finding(s) of hepatocellular carcinoma with CT or MRI imaging
    2. Patients who underwent tumor biopsy and are histopathologically diagnosed as hepatocellular carcinoma 4. First onset or recurrence of hepatocellular carcinoma is not more than 1 time.

    5. Patients who underwent the following 1) or 2) prior to registration to determine therapeutic effect.

    1. Patients who underwent local therapy to achieve complete hepatonecrosis and are confirmed to have complete hepatonecrosis with CT imaging or MRI.

    2. Patients who underwent surgical treatment(s) and are confirmed not to have residual tumor with CT or MRI imaging. 6. Patients who are given full explanation of study participation (including cancer notification) and submit written consent forms with their understanding as well as voluntary will for this study.

      Exclusion Criteria:

    1. Hepatocellular carcinoma: 1) Patients who have extrahepatic metastasis 2) Patients who have portal invasion 3) Patients who experienced with systemic administration of anti-malignant tumor drugs to treat hepatocellular carcinoma
    2. Patients with encephalopathy in which pharmacotherapy is ineffective
    3. Patients with ascites or pleural effusion that cannot be managed with diuretics
    4. Systemic conditions:
    1. Patients unable to receive oral administration
    2. Patients with a history of gastrectomy or extensive resection of digestive tract
    3. Patients who are suspected to have biliary occlusion, choleretic disorder,cholecystectomy, or malabsorption of liposoluble agents
    4. Patients with multiple cancers (within a 5-year cancer-free period [from the same day of 5 years earlier to the day of obtaining consent forms) 5. Drug administration:
    1. Patients on warfarin therapy
    2. Patients who already use statin or metformin 6.Other exclusion criteria
    1. Women of pregnant, lactating, childbearing potential, or with the intention of becoming pregnant
    2. Patients who are presently participating in another clinical study (except for follow-up surveys for study outcomes)
    3. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator
    4. GOT or GPT three times greater than normal
    5. Cr. 1.5 times greater than normal
    6. Child-pugh score C

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: Taking both statin and metformin Group
The experimental group take Lotidon 500mg/ tablet per day and Lipitor 10mg/ tablet per day for two years or until of a recurrence.
Drug: Statin and Metformin use
No Intervention: Non- taking both statin and metformin Group
Non- taking both statin and metformin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
relapse-free survival of hepatocellular carcinoma patients
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

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

Sponsor

Taipei Medical University WanFang Hospital

Investigators

  • Study Director: Fa-Moon Suk, bachelor, Taipei Medical University, Taiwan, R.O.C.

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)

August 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 14, 2016

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 19, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201510039

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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