Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment

Phase 4Active Not RecruitingNCT03024684

Chiayi Christian Hospital240 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

240

Conditions

HepatoCellular Carcinoma

Interventions

AtorvastatinDRUG

Atorvastatin 10mg daily

Placebo Oral TabletDRUG

Placebo one tablet daily

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (6)

Ditmanson Medical Foundation Chiayi Christian Hospital

Chiayi City, Taiwan

E-DA Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Tainan Municipal Hospital

Tainan, Taiwan

Outcomes

Primary Outcomes

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

Recurrence rate of HCC

Time frame: 3 years

Secondary Outcomes

occurrence of clinical complications related to hepatic decompensation

clinical complications or hepatic decompensation

Time frame: 3 years

Data from ClinicalTrials.gov

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