Clinical Trials in Taiwan / NCT03024684
Active, not recruiting
Phase 4
Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment
NCT03024684 · tracked via the Priya Life Science Taiwan tracker
Condition(s) studied
HepatoCellular Carcinoma
Investigational drug(s) / intervention(s)
Atorvastatin →Placebo Oral Tablet
Atorvastatin: Atorvastatin 10mg daily
Placebo Oral Tablet: Placebo one tablet daily
Study summary
The purpose of this study is to evaluate whether statin could prevent recurrence of hepatocellular carcinoma after curative treatment
Eligibility
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
Primary outcome measure(s)
- 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart — 3 years
Recurrence rate of HCC
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | |
| Mackay Memorial Hospital | Taipei | Taiwan | |
| National Taiwan University Hospital Yun-Lin Branch | Yunlin | Taiwan |
On this site
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03024684 on ClinicalTrials.gov ↗ ← All trials in Taiwan