Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment (SHOT)
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ClinicalTrials.gov Identifier: NCT03024684 |
Recruitment Status :
Recruiting
First Posted : January 19, 2017
Last Update Posted : April 28, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HepatoCellular Carcinoma | Drug: Atorvastatin Drug: Placebo Oral Tablet | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment: a Double-blind Randomized Placebo-controlled Trial |
Actual Study Start Date : | January 3, 2017 |
Estimated Primary Completion Date : | January 2025 |
Estimated Study Completion Date : | January 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Statin
Atorvastatin 10mg oral once daily
|
Drug: Atorvastatin
Atorvastatin 10mg daily |
Placebo Comparator: Placebo
Matched placebo (sugar pill) once daily
|
Drug: Placebo Oral Tablet
Placebo one tablet daily |
- 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart [ Time Frame: 3 years ]Recurrence rate of HCC
- occurrence of clinical complications related to hepatic decompensation [ Time Frame: 3 years ]clinical complications or hepatic decompensation
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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024684
Contact: Po Yueh Chen, Doctor | +886919860356 | hdilwy7@gmail.com |
Taiwan | |
Ditmanson Medical Foundation Chiayi Christian Hospital | Recruiting |
Chiayi City, Taiwan | |
E-DA Hospital | Recruiting |
Kaohsiung, Taiwan | |
Taichung Veterans General Hospital | Recruiting |
Taichung, Taiwan | |
Tainan Municipal Hospital | Recruiting |
Tainan, Taiwan | |
Mackay Memorial Hospital | Recruiting |
Taipei, Taiwan | |
National Taiwan University Hospital Yun-Lin Branch | Not yet recruiting |
Yunlin, Taiwan |
Principal Investigator: | Po Yueh Chen, Doctor | Ditmanson Medical Foundation Chia-Yi Christian Hospital |
Responsible Party: | Chiayi Christian Hospital |
ClinicalTrials.gov Identifier: | NCT03024684 |
Other Study ID Numbers: |
105005 |
First Posted: | January 19, 2017 Key Record Dates |
Last Update Posted: | April 28, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Hepatocellular carcinoma statin curative ablation |
Carcinoma Carcinoma, Hepatocellular Recurrence Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Liver Diseases Disease Attributes Pathologic Processes Atorvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |