NCT03024684

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_4 hepatocellular-carcinoma

Timeline
8mo left

Started Jan 2017

Longer than P75 for phase_4 hepatocellular-carcinoma

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jan 2017Jan 2027

Study Start

First participant enrolled

January 3, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

8 years

First QC Date

January 15, 2017

Last Update Submit

November 9, 2024

Conditions

HepatoCellular Carcinoma

Keywords

Hepatocellular carcinomastatincurative ablation

Outcome Measures

Primary Outcomes (1)

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

    Recurrence rate of HCC

    3 years

Secondary Outcomes (1)

  • occurrence of clinical complications related to hepatic decompensation

    3 years

Study Arms (2)

Statin

EXPERIMENTAL

Atorvastatin 10mg oral once daily

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

Matched placebo (sugar pill) once daily

Drug: Placebo Oral Tablet

Interventions

AtorvastatinDRUG

Atorvastatin 10mg daily

Statin
Placebo Oral TabletDRUG

Placebo one tablet daily

Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ditmanson Medical Foundation Chiayi Christian Hospital

Chiayi City, Taiwan

Location

E-DA Hospital

Kaohsiung City, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Tainan Municipal Hospital

Tainan, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital Yun-Lin Branch

Yunlin, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Po Yueh Chen, Doctor

    Ditmanson Medical Foundation Chia-Yi Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2017

First Posted

January 19, 2017

Study Start

January 3, 2017

Primary Completion

January 1, 2025

Study Completion (Estimated)

January 1, 2027

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(6)