Clinical trial NCT03024684: Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment
Official title: Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment: a Double-blind Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: HepatoCellular Carcinoma
Keywords: Hepatocellular carcinoma
statin
curative ablation
Lead sponsor: Chiayi Christian Hospital
Sponsor class: OTHER
Collaborators: name: E-DA Hospital
name: National Taiwan University Hospital
name: Taichung Veterans General Hospital
name: Mackay Memorial Hospital
name: Tainan Municipal Hospital
name: National Cheng-Kung University Hospital
name: Chi Mei Medical Hospital
First posted: 2017-01-19
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart
timeFrame: 3 years
Secondary outcomes:
measure: occurrence of clinical complications related to hepatic decompensation
timeFrame: 3 years
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Ditmanson Medical Foundation Chiayi Christian Hospital
city: Kaohsiung
country: Taiwan
facility: E-DA Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: Tainan Municipal Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Yunlin
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
Study officials:
affiliation: Ditmanson Medical Foundation Chia-Yi Christian Hospital
name: Po Yueh Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References: