Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment

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

Detailed Description
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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.

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

Conditions
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HepatoCellular Carcinoma

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Statin<br>Atorvastatin 10mg oral once daily | Drug: Atorvastatin<br>* Atorvastatin 10mg daily<br>|
| Placebo Comparator: Placebo<br>Matched placebo (sugar pill) once daily | Drug: Placebo Oral Tablet<br>* Placebo one tablet daily<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, statin, curative ablation