Sorafenib vs.TransArterial Chemoembolization Plus RadioTherapy in Hepatocellular Carcinoma With M… (NCT01901692) | Clinical Trial Compass
CompletedPhase 2/3
Sorafenib vs.TransArterial Chemoembolization Plus RadioTherapy in Hepatocellular Carcinoma With Macrovascular Invasion
South Korea90 participantsStarted 2013-07-29
Plain-language 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 intrahepatic vessels
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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