A Phase Ib Study of Stereotactic Body Radiotherapy (SBRT) Plus Sorafenib in Patients With Unresectable Hepatocellular Carcinoma (HCC)

Inclusion criteria

• ✓.1.1Age ≥ 18 years. 4.1.2 Patients with HCC without cirrhosis or with CTP class A (maximum score 6).
• ✓.1.3 Patient must not be a surgical candidate at presentation. 4.1.4 Able to undergo contrast enhanced MRI of the primary tumor using the liver MRI protocol.
• ✓.1.5 Measurable disease per mRECIST criteria defined as lesions \>/=1cm showing intratumoral arterial enhancement in contrast-enhanced CT or MRI and being suitable for repeat measurements.
• ✓.1.6 Must not have evidence of metastatic disease. 4.1.7 Karnofsky performance status \>/=70% 4.1.8 Life expectancy ≥ 3 months as determined by the treating physician. 4.1.9 If single tumor, maximum tumor diameter must be \</= 6 cm. 4.1.10 No more than three discrete liver lesions, with the overall sum of diameters being \</= 6 cm.
• ✓.1.11 None of the lesions to be treated can be in closer than 0.5 cm to the wall of the stomach, duodenum, or hepatic flexure of the colon.
• ✓.1.12 Radiotherapy treatment planning confirms one of the following:
• ✓.1.15 Patients must have adequate liver function within 2 weeks of study registration. Adequate liver function is defined as all of the following:
• ✓.1.19 Women must not be pregnant or breastfeeding. The effects of Sorafenib on the developing human fetus are unknown. For this reason and because radiation therapy and Sorafenib used in this trial are may be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion criteria