Status:
TERMINATED
Statin Combination Therapy in Patients Receiving Sorafenib for Advanced Hepatocellular Carcinoma
Lead Sponsor:
Taichung Veterans General Hospital
Conditions:
Overall Survival
Tumor Responses
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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 stati...
Detailed Description
Background: Hepatocellular carcinoma (HCC) is the second leading cause of cancer death worldwide, including the condition in Taiwan, and the management of HCC is an important challenge in public heal...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03275376
Start Date
December 21 2017
End Date
March 13 2021
Last Update
March 16 2021
Active Locations (1)
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1
Taichung Veterans General Hospital
Taichung, Taiwan, 40705