Study Stopped
Slow in patient enrollment
Statin Combination Therapy in Patients Receiving Sorafenib for Advanced Hepatocellular Carcinoma
1 other identifier
interventional
34
1 country
1
Brief Summary
Target therapy with sorafenib is the standard of treatment for advanced Hepatocellular carcinoma (HCC), but the patient survival time is still unsatisfactory. The aims of this study are to prove statins improve the tumor responses and overall survival for patients who receive sorafenib therapy for advanced HCC by a prospective randomized controlled study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2017
CompletedFirst Posted
Study publicly available on registry
September 7, 2017
CompletedStudy Start
First participant enrolled
December 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2021
CompletedMarch 16, 2021
March 1, 2021
3 years
September 5, 2017
March 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
Three year
Secondary Outcomes (2)
Best tumor response
Three year
Progression free survival
Three year
Study Arms (2)
Statin treated group
EXPERIMENTALControl group
PLACEBO COMPARATORInterventions
Atorvastatin or placebo will be administered according to randomized allocations.
Atorvastatin or placebo will be administered according to randomized allocations.
Eligibility Criteria
You may qualify if:
- Patients more than 40 years old
- HCCs diagnosed by AASLD image criteria or pathology
- HCCs in BCLC advanced stage, with portal vein thrombosis (VP3 or VP4) or extrahepatic metastasis
- Not suitable or failed to locoreginal treatments for HCC
- Child-Pugh score = or \< 6
- ECOG performance status (PST) 0-2
- Serum bilirubin \< 2 mg/dL and prothrombin time (PT) prolongation \< 3 seconds
- Will receive sorafenib therapy
- Life expectancy \> 3 months
- Will follow the pregnancy prevention protocol
You may not qualify if:
- HCC is considered for curative therapy
- HCC with brain metastasis
- History of systemic therapy for HCC
- Indications for statin use, such as hyperlipidemia in cardiovascular diseases
- Any local treatment for HCC within 4 weeks
- Any active gastrointestinal bleeding within 4 weeks
- Liver transplant history or concomitant immunosuppressive therapy
- Concurrent any other malignancy
- Allergy to sorafenib or statins
- Pregnancy or lactation
- Serum AST or ALT \> 5x upper limit of normal
- Known HIV infection
- eGFR \< 30 ml/min
- Abnormal medical conditions that are unsuitable for study, such as uncontrolled hypertension, coronary arterial disease, or arrhythmia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Related Publications (1)
1. Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 2008;359:378-390. 2. Cheng AL, Kang YK, Chen Z, et al. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol 2009;10:25-34. 3. Cainap C, Qin S, Huang WT, et al. Linifanib versus Sorafenib in patients with advanced hepatocellular carcinoma: results of a randomized phase III trial. J Clin Oncol 2015;33:172-179. 4. Llovet JM, Decaens T, Raoul JL, et al. Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed: results from the randomized phase III BRISK-PS study. J Clin Oncol 2013;31:3509-3516. 5. Singh S, Singh PP, Roberts LR, et al. Chemopreventive strategies in hepatocellular carcinoma. Nat Rev Gastroenterol Hepatol 2014;11:45-54. 6. Demierre MF, Higgins PD, Gruber SB, et al. Statins and cancer prevention. Nat Rev Cancer 2005;5:930-942. 7. Wu J, Wong WW, Khosravi F, et al. Blocking the Raf/MEK/ERK pathway sensitizes acute myelogenous leukemia cells to lovastatin-induced apoptosis. Cancer Res 2004;64:6461-6468. 8. Rao S, Porter DC, Chen X, et al. Lovastatin-mediated G1 arrest is through inhibition of the proteasome, independent of hydroxymethyl glutaryl-CoA reductase. Proc Natl Acad Sci U S A 1999;96:7797-7802. 9. El-Serag HB, Johnson ML, Hachem C, et al. Statins are associated with a reduced risk of hepatocellular carcinoma in a large cohort of patients with diabetes. Gastroenterology 2009;136:1601-1608. 10. Tsan YT, Lee CH, Wang JD, et al. Statins and the risk of hepatocellular carcinoma in patients with hepatitis B virus infection. J Clin Oncol 2012;30:623-630. 11. Chiu HF, Ho SC, Chen CC, et al. Statin use and the risk of liver cancer: a population-based case-control study. Am J Gastroenterol 2011;106:894-898.
BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Teng-Yu Lee, MD
Taichung Veterans General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
September 5, 2017
First Posted
September 7, 2017
Study Start
December 21, 2017
Primary Completion
December 21, 2020
Study Completion
March 13, 2021
Last Updated
March 16, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share