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NCT03024684Active, not recruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 12 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
240 (actual)
First submitted
15 Jan 2017
Start date
3 Jan 2017
Primary completion date
31 Jan 2025
Lead sponsor
Chiayi Christian Hospital
NCT number
NCT03024684

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 240
  • From 3 Jan 2017 to the primary completion date, 31 Jan 2025
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous history of CAD event (angina, unstable angina, acute myocardial infarction) or ischemic stroke

Other illness

  • With other malignant disease
  • Allergy to statin

Lab values

  • Advanced CKD (eGFR\<30) or ESRD

Age

  • Severe comorbidity with life expectancy \< 2 years

Other

  • Undetermined nature of hepatic tumor
  • HCC with extrahepatic metastasis or major vascular invasion
  • Child Pugh score \>7
  • Hyperlipidemia or other indication for statin (according to Taiwan NHI guideline)

Who the study is looking for

  • 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

Age in the registry: 20 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ditmanson Medical Foundation Chiayi Christian Hospital
Coordinator of this site? Confirm its status
Chiayi CityTaiwanUnknown status
E-DA Hospital
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanUnknown status
Taichung Veterans General Hospital
Coordinator of this site? Confirm its status
TaichungTaiwanUnknown status
Tainan Municipal Hospital
Coordinator of this site? Confirm its status
TainanTaiwanUnknown status
MacKay Memorial Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
National Taiwan University Hospital Yun-Lin Branch
Coordinator of this site? Confirm its status
YunlinTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.