Radiation Dose Escalation Study for Advanced Liver Cancer

Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma

The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of 3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy (IMRT) for locally advanced hepatocellular carcinoma (HCC).

Inclusion Criteria:

• Pathologically confirmed or clinically diagnosed HCC
• Surgically unsectable or medically inoperable diseases, or surgery declined by the patient
• Solitary intrahepatic lesion with diameter bigger than 5 cm, without extrahepatic and/or distant metastases
• Associated with cirrhosis of Child-Pugh A
• Karnofsky performance status (KPS) of ≥ 70
• Normal renal function and adequate bone marrow reservation
• Tolerate active breathing control (ABC)

Exclusion Criteria:

• Child-Pugh B or C liver cirrhosis score
• Previous radiotherapy to the liver
• Indistinct tumor boundary in CT/MRI image