Status:
COMPLETED
Sorafenib vs.TransArterial Chemoembolization Plus RadioTherapy in Hepatocellular Carcinoma With Macrovascular Invasion
Lead Sponsor:
Asan Medical Center
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
Brief Summary
To evaluate and compare the efficacy and safety of sorafenib versus trans-arterial chemoembolization plus external beam radiation therapy in patients with hepatocellular carcinoma invading major intra...
Detailed Description
Current practice guidelines recommend only sorafenib for patients with hepatocellular carcinoma invading major intrahepatic vessels. However, recent data from observational studies suggest that the co...
Eligibility Criteria
Inclusion
- Age \>19 years
- Child-Pugh class A liver function
- Performance status: Eastern Cooperative Oncology Group (ECOG) score 0 or 1
- Hepatocellular carcinoma (HCC) confirmed by dynamic CT or MRI, or by biopsy
- HCC invasion of first or second branch portal vein or hepatic vein or inferior vena cava
- Reserved unilateral portal blood flow at least in partial
- HCC size larger than 1 cm and less than 50% of total liver volume
- No confirmed extrahepatic metastasis
- Adequate hematopoietic function Hemoglobin ≥ 8.5 g/dL Absolute neutrophil count ≥ 750/mm3 Platelet count ≥ 30,000/mm3
- Creatinine \< 1.5mg/dL
- No plan for pregnancy or breast feeding. Active contraception.
- Willing to give informed consent
Exclusion
- Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
- Complete obstruction of hepatic outflow
- Confirmed extrahepatic metastasis of HCC
- HCC occupying more than 50% of liver volume
- Uncontrolled ascites of hepatic encephalopathy
- Prior liver transplantation
- Positive for human immunodeficiency virus (HIV)
- Active gastric or duodenal ulcer
- Other uncontrolled comorbidities or malignancy
- Inability to give informed consent
Key Trial Info
Start Date :
July 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2017
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01901692
Start Date
July 29 2013
End Date
August 31 2017
Last Update
September 18 2017
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05505