Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment

HepatoCellular Carcinoma Clinical Trial

— SHOT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03024684
• Other study ID #: 105005
• Status: Recruiting
• Phase: Phase 4
• Start date: January 3, 2017
• Est. completion date: January 2027

Study information

• Verified date: April 2022
• Source: Chiayi Christian Hospital
• Contact: Po Yueh Chen, Doctor
• Phone: +886919860356
• Email: hdilwy7[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 2027
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• HepatoCellular Carcinoma
• Recurrence

Intervention

Drug:
• Atorvastatin
Atorvastatin 10mg daily
• Placebo Oral Tablet
Placebo one tablet daily

Locations

Country	Name	City	State
Taiwan	Ditmanson Medical Foundation Chiayi Christian Hospital	Chiayi City
Taiwan	E-DA Hospital	Kaohsiung
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

Sponsors (8)

Lead Sponsor	Collaborator
Chiayi Christian Hospital	Chi Mei Medical Hospital, E-DA Hospital, Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Taiwan University Hospital, Taichung Veterans General Hospital, Tainan Municipal Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart	Recurrence rate of HCC	3 years
Secondary	occurrence of clinical complications related to hepatic decompensation	clinical complications or hepatic decompensation	3 years