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

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ClinicalTrials.gov Identifier: NCT03024684
Recruitment Status : Recruiting
First Posted : January 19, 2017
Last Update Posted : April 28, 2022
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

Study Description
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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.
Study Design
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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 2025
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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


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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 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 radiofrequency ablation or hepatic resection could be eligible.
  • Individuals who had single HCC (size > 5.0 cm) received hepatic resection would be eligible
  • Individuals with prior history of HCC who had ever received curative ablation or hepatic resection without any recurrence for more than 2 years could be eligible if they had a new episode of recurrent HCC which could meet either of the former two criteria.
  • After 12+/-1 weeks of curative treatment, eligible patients who have no evidence of local residual or recurrent tumors according to the dynamic CT or MRI could be enrolled
  • The diagnosis of fresh HCC should be compatible with either pathological report or meet the criteria of AASLD guidelines

Exclusion Criteria:

  • Undetermined nature of hepatic tumor
  • HCC with extrahepatic metastasis or major vascular invasion
  • With 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
Contacts and Locations
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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
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Contact: Po Yueh Chen, Doctor +886919860356 hdilwy7@gmail.com

Locations
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Taiwan
Ditmanson Medical Foundation Chiayi Christian Hospital Recruiting
Chiayi City, Taiwan
E-DA Hospital Recruiting
Kaohsiung, Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, 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
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Principal Investigator: Po Yueh Chen, Doctor Ditmanson Medical Foundation Chia-Yi Christian Hospital
More Information
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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: April 28, 2022
Last Verified: April 2022
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:
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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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors