Sorafenib vs.TransArterial Chemoembolization Plus RadioTherapy in Hepatocellular Carcinoma With Macrovascular Invasion

• Status: Completed
• Trial end date: 2017-08-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Niacinamide; Sorafenib

Criteria

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