Trial | NCT03024684  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Recruiting

  • Intervention/Treatment

    atorvastatin ...

  • Study Participants

    240
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 Started
Jan 03
2017
Primary Completion
Jan 31
2025
Anticipated
Study Completion
Jan 31
2027
Anticipated
Last Update
Apr 28
2022

Drug Atorvastatin

Atorvastatin 10mg daily

Drug Placebo Oral Tablet

Placebo one tablet daily

Statin Experimental

Atorvastatin 10mg oral once daily

Placebo Placebo Comparator

Matched placebo (sugar pill) once daily

Criteria 

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
No Results Posted