NCT01901692.

Trial name or title	Transarterial chemoembolisation plus radiotherapy or sorafenib in hepatocellular carcinoma with major vascular invasion (START)
Methods	Randomised phase II trial
Participants	People with hepatocellular carcinoma invading major intrahepatic vessels Country: Korea
Interventions	transarterial chemoembolisation (TACE) + external beam radiotherapy versus sorafenib
Outcomes	Primary endpoint progression‐free survival Secondary endpoints Response rate [ Time Frame: at 3 months after randomisation ] [ Designated as safety issue: No ] Time to failure of treatment Progression‐free survival Treatment‐related adverse events Overall survival
Starting date	July 2013
Contact information	Young‐Suk Lim, Associate Professor, Asan Medical Center
Notes	Estimated enrolment: 90 Inclusion criteria: Age > 19 years. Child‐Pugh class A liver function. Performance status: ECOG score 0 or 1. Hepatocellular carcinoma confirmed by dynamic computed tomography (CT) or MRI, or by biopsy. Hepatocellular carcinoma invasion of first or second branch portal vein or hepatic vein or inferior vena cava. Reserved unilateral portal blood flow at least partially. Hepatocellular carcinoma size larger than 1 cm and less than 50% of total liver volume. No extrahepatic metastasis. Adequate haematopoietic function: haemoglobin ≥ 8.5 g/dL; absolute neutrophil count ≥ 750/mm3; platelet count ≥ 30,000/mm3. Creatinine < 1.5 mg/dL. No plan for pregnancy or breastfeeding. Active contraception. Willing to give informed consent.