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

Asan Medical Center

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Radiation: TACE+External beam RT; Drug: Sorafenib

Study type: Interventional

Funder types: Other

Identifiers

NCT01901692

AMC IRB 2013-0627

Details and patient eligibility

About

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

Full 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 combination of transarterial chemoembolization and external beam radiotherapy would be as effective as sorafenib.

Enrollment: 90 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

TACE+External beam RT

Experimental group

Description:

Transarterial chemoembolization plus external beam radiation therapy

Treatment:

Radiation: TACE+External beam RT

Sorafenib

Active Comparator group

Description:

Sorafenib 800 mg/day orally

Treatment:

Drug: Sorafenib