Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment (SHOT)

Chiayi Christian Hospital

Status and phase: Active, not recruiting; Phase 4

Conditions: HepatoCellular Carcinoma

Treatments: Drug: Atorvastatin; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03024684

105005

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups, including a placebo group

Statin

Experimental group

Description:

Atorvastatin 10mg oral once daily

Treatment:

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

Matched placebo (sugar pill) once daily

Treatment:

Drug: Placebo Oral Tablet