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

Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment: a Double-blind Randomized Placebo-controlled Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: HepatoCellular Carcinoma
• Intervention / Treatment: Drug: Placebo Oral Tablet; Drug: Atorvastatin

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Chiayi City, Taiwan
    • Ditmanson Medical Foundation Chiayi Christian Hospital
  • Kaohsiung, Taiwan
    • E-DA Hospital
  • Taichung, Taiwan
    • Taichung Veterans General Hospital
  • Tainan, Taiwan
    • Tainan Municipal Hospital
  • Taipei, Taiwan
    • Mackay Memorial Hospital
  • Yunlin, Taiwan
    • National Taiwan University Hospital Yun-Lin Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart	Recurrence rate of HCC	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of clinical complications related to hepatic decompensation	clinical complications or hepatic decompensation	3 years

Collaborators and Investigators

• Sponsor: Chiayi Christian Hospital
• Collaborators: National Taiwan University Hospital; Mackay Memorial Hospital; National Cheng-Kung University Hospital; Tainan Municipal Hospital; Taichung Veterans General Hospital; E-DA Hospital; Chi Mei Medical Hospital
• Investigators: Principal Investigator: Po Yueh Chen, Doctor, Ditmanson Medical Foundation Chia-Yi Christian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2017
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 15, 2017
• First Submitted That Met QC Criteria: January 15, 2017
• First Posted (Estimated): January 19, 2017

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 9, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Hepatocellular carcinoma; statin; curative ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Recurrence; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 105005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO