Spots Global Cancer Trial Database for Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment

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Trial Identification

Brief Title: Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment

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

Study ID: NCT03024684

Conditions

HepatoCellular Carcinoma

Interventions

Atorvastatin

Placebo Oral Tablet

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.