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SHOT: Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment

Sponsor
Chiayi Christian Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03024684
Collaborator
E-DA Hospital (Other), National Taiwan University Hospital (Other), Taichung Veterans General Hospital (Other), Mackay Memorial Hospital (Other), Tainan Municipal Hospital (Other), National Cheng-Kung University Hospital (Other), Chi Mei Medical Hospital (Other)
240
Enrollment
6
Locations
2
Arms
119.9
Anticipated Duration (Months)
40
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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 :
Jan 3, 2017
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2027

Arms and Interventions

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

Primary Outcome Measures

  1. 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart [3 years]

    Recurrence rate of HCC

Secondary Outcome Measures

  1. occurrence of clinical complications related to hepatic decompensation [3 years]

    clinical complications or hepatic decompensation

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Ditmanson Medical Foundation Chiayi Christian Hospital Chiayi City Taiwan
2 E-DA Hospital Kaohsiung Taiwan
3 Taichung Veterans General Hospital Taichung Taiwan
4 Tainan Municipal Hospital Tainan Taiwan
5 Mackay Memorial Hospital Taipei Taiwan
6 National Taiwan University Hospital Yun-Lin Branch 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

  • Principal Investigator: Po Yueh Chen, Doctor, Ditmanson Medical Foundation Chia-Yi Christian Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chiayi Christian Hospital
ClinicalTrials.gov Identifier:
NCT03024684
Other Study ID Numbers:
  • 105005
First Posted:
Jan 19, 2017
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Chiayi Christian Hospital
Hepatocellular carcinoma
statin
curative ablation
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Atorvastatin

Study Results

No Results Posted as of Apr 28, 2022