search
Back to results

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

Primary Purpose

HepatoCellular Carcinoma

Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Atorvastatin
Placebo Oral Tablet
Sponsored by
Chiayi Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HepatoCellular Carcinoma focused on measuring Hepatocellular carcinoma, statin, curative ablation

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ditmanson Medical Foundation Chiayi Christian HospitalRecruiting
  • E-DA HospitalRecruiting
  • Taichung Veterans General HospitalRecruiting
  • Tainan Municipal HospitalRecruiting
  • Mackay Memorial HospitalRecruiting
  • National Taiwan University Hospital Yun-Lin Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Statin

Placebo

Arm Description

Atorvastatin 10mg oral once daily

Matched placebo (sugar pill) once daily

Outcomes

Primary Outcome Measures

3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart
Recurrence rate of HCC

Secondary Outcome Measures

occurrence of clinical complications related to hepatic decompensation
clinical complications or hepatic decompensation

Full Information

First Posted
January 15, 2017
Last Updated
April 26, 2022
Sponsor
Chiayi Christian Hospital
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
search

1. Study Identification

Unique Protocol Identification Number
NCT03024684
Brief Title
Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment
Acronym
SHOT
Official Title
Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment: a Double-blind Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiayi Christian Hospital
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HepatoCellular Carcinoma
Keywords
Hepatocellular carcinoma, statin, curative ablation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Statin
Arm Type
Experimental
Arm Description
Atorvastatin 10mg oral once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo (sugar pill) once daily
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 10mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo one tablet daily
Primary Outcome Measure Information:
Title
3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart
Description
Recurrence rate of HCC
Time Frame
3 years
Secondary Outcome Measure Information:
Title
occurrence of clinical complications related to hepatic decompensation
Description
clinical complications or hepatic decompensation
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Po Yueh Chen, Doctor
Phone
+886919860356
Email
hdilwy7@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Po Yueh Chen, Doctor
Organizational Affiliation
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ditmanson Medical Foundation Chiayi Christian Hospital
City
Chiayi City
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
E-DA Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Tainan Municipal Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital Yun-Lin Branch
City
Yunlin
Country
Taiwan
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment

We'll reach out to this number within 24 hrs