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The Combination Effect of Statin Plus Metformin on Relapse-free

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Statin and Metformin use
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Taipei Medical University - WanFang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Taking both statin and metformin Group

Non- taking both statin and metformin Group

Arm Description

The experimental group take Lotidon 500mg/ tablet per day and Lipitor 10mg/ tablet per day for two years or until of a recurrence.

Non- taking both statin and metformin.

Outcomes

Primary Outcome Measures

relapse-free survival of hepatocellular carcinoma patients

Secondary Outcome Measures

Full Information

First Posted
June 28, 2016
Last Updated
April 18, 2017
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02819869
Brief Title
The Combination Effect of Statin Plus Metformin on Relapse-free
Official Title
The Combination Effect of Statin Plus Metformin on Relapse-free
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
insufficient for the fund
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
December 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study demonstrated that either statin or metformin served as notable use in reducing the incidence of many cancers.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taking both statin and metformin Group
Arm Type
Experimental
Arm Description
The experimental group take Lotidon 500mg/ tablet per day and Lipitor 10mg/ tablet per day for two years or until of a recurrence.
Arm Title
Non- taking both statin and metformin Group
Arm Type
No Intervention
Arm Description
Non- taking both statin and metformin.
Intervention Type
Drug
Intervention Name(s)
Statin and Metformin use
Primary Outcome Measure Information:
Title
relapse-free survival of hepatocellular carcinoma patients
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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). Patients who are confirmed to have early tumor stain and typical finding(s) of hepatocellular carcinoma with CT or MRI imaging 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. Patients who underwent local therapy to achieve complete hepatonecrosis and are confirmed to have complete hepatonecrosis with CT imaging or MRI. 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: 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 Patients with encephalopathy in which pharmacotherapy is ineffective Patients with ascites or pleural effusion that cannot be managed with diuretics Systemic conditions: Patients unable to receive oral administration Patients with a history of gastrectomy or extensive resection of digestive tract Patients who are suspected to have biliary occlusion, choleretic disorder,cholecystectomy, or malabsorption of liposoluble agents 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: Patients on warfarin therapy Patients who already use statin or metformin 6.Other exclusion criteria Women of pregnant, lactating, childbearing potential, or with the intention of becoming pregnant Patients who are presently participating in another clinical study (except for follow-up surveys for study outcomes) Patients who are judged to be ineligible for study entry by the investigator or subinvestigator GOT or GPT three times greater than normal Cr. 1.5 times greater than normal Child-pugh score C
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fa-Moon Suk, bachelor
Organizational Affiliation
Taipei Medical University, Taiwan, R.O.C.
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Medical University - WanFang Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Combination Effect of Statin Plus Metformin on Relapse-free

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