Clinical trial · Interventional
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
NCT03024684CI-TRIAL-00082470SHOTactive not recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate whether statin could prevent recurrence of hepatocellular carcinoma after curative treatment
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HepatoCellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
| Placebo Oral Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Statin
- description
- Atorvastatin 10mg oral once daily
- interventionNames
- Drug: Atorvastatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Matched placebo (sugar pill) once daily
- interventionNames
- Drug: Placebo Oral Tablet
Primary outcomes (1)
- measure
- 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.