Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment (SHOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03024684
Recruitment Status : Recruiting
First Posted : January 19, 2017
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
E-DA Hospital
National Taiwan University Hospital
Taichung Veterans General Hospital
Mackay Memorial Hospital
Tainan Municipal Hospital
National Cheng-Kung University Hospital
Chi Mei Medical Hospital
Information provided by (Responsible Party):
Chiayi Christian Hospital

Brief Summary:
The purpose of this study is to evaluate whether statin could prevent recurrence of hepatocellular carcinoma after curative treatment

Condition or disease Intervention/treatment Phase
HepatoCellular Carcinoma Drug: Atorvastatin Drug: Placebo Oral Tablet Phase 4

Detailed Description:
This is a multi-center double-blind randomized placebo-controlled trial. A total of 240 patients with HCC at BCLC stage 0 or A will be enrolled from 8 hospitals in Taiwan. After complete ablation or hepatic resection of the tumor(s), participants are randomized 1:1 to receive either atorvastatin 10mg once daily (intervention group) or matched placebo (control group) for 3 years. During the 3-year period, patients are monitored for recurrence of HCC by dynamic computed tomography (or magnetic resonance image) every 4 months. They will be followed up until death, withdrawal from participation, study termination, or 3 years after the ablative treatment. The primary endpoint is to compare the 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart. Secondary endpoints are occurrence of clinical complications related to hepatic decompensation (including gastroesophageal variceal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and hepatopulmonary syndrome), liver-related mortality, and all-cause mortality.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment: a Double-blind Randomized Placebo-controlled Trial
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Statin
Atorvastatin 10mg oral once daily
Drug: Atorvastatin
Atorvastatin 10mg daily

Placebo Comparator: Placebo
Matched placebo (sugar pill) once daily
Drug: Placebo Oral Tablet
Placebo one tablet daily




Primary Outcome Measures :
  1. 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. occurrence of clinical complications related to hepatic decompensation [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

.Individuals with HCC BCLC stage 0 or A who received curative ablation or hepatic resection could be eligible. After 12+/-1 weeks of curative treatment, eligible patients who have no evidence of local residual tumor according to the dynamic CT or MRI could be enrolled

Exclusion Criteria:

  • Undetermined nature of hepatic tumor
  • Other malignant disease
  • Child Pugh score >7
  • Previous history of CAD event (angina, unstable angina, acute myocardial infarction) or ischemic stroke
  • Hyperlipidemia or other indication for statin (according to Taiwan NHI guideline)
  • Advanced CKD (eGFR<30) or ESRD
  • Severe comorbidity with life expectancy < 2 years
  • Allergy to statin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024684


Contacts
Layout table for location contacts
Contact: Po Yueh Chen, Doctor +886919860356 hdilwy7@gmail.com

Locations
Layout table for location information
Taiwan
Ditmanson Medical Foundation Chiayi Christian Hospital Recruiting
Chiayi City, Taiwan
E-DA Hospital Recruiting
Kaohsiung, Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan
Chi Mei Medical Hospital Not yet recruiting
Tainan, Taiwan
National Cheng-Kung University Hospital Not yet recruiting
Tainan, Taiwan
Tainan Municipal Hospital Recruiting
Tainan, Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan
National Taiwan University Hospital Yun-Lin Branch Not yet recruiting
Yunlin, Taiwan
Sponsors and Collaborators
Chiayi Christian Hospital
E-DA Hospital
National Taiwan University Hospital
Taichung Veterans General Hospital
Mackay Memorial Hospital
Tainan Municipal Hospital
National Cheng-Kung University Hospital
Chi Mei Medical Hospital
Investigators
Layout table for investigator information
Principal Investigator: Po Yueh Chen, Doctor Ditmanson Medical Foundation Chia-Yi Christian Hospital

Layout table for additonal information
Responsible Party: Chiayi Christian Hospital
ClinicalTrials.gov Identifier: NCT03024684    
Other Study ID Numbers: 105005
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chiayi Christian Hospital:
Hepatocellular carcinoma
statin
curative ablation
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors