The Combination Effect of Statin Plus Metformin on Relapse-free

NCT02819869 | Terminated Phase 2

• 1 other identifier: N201510039
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• relapse-free survival of hepatocellular carcinoma patients

  Up to 2 years

Study Arms (2)

Taking both statin and metformin Group

EXPERIMENTAL

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

Non- taking both statin and metformin Group

NO INTERVENTION

Non- taking both statin and metformin.

Interventions

Statin and Metformin use DRUG

Taking both statin and metformin Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.

You may not qualify if:

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• 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:
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• 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:
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• Patients on warfarin therapy
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• 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)

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University - WanFang Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Fa-Moon Suk, bachelor

  Taipei Medical University, Taiwan, R.O.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 14, 2016
• Last Updated: April 19, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)