Combination Chemoembolization and Stereotactic Body Radiation Therapy in Unresectable Hepatocellular Carcinoma
Age: 18 years - 66+
Healthy Subjects: No
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: November 01, 2014
End Date: January 01, 2019
- Participants must be diagnosed with HCC either pathologically or by the American Association for the Study of Liver Diseases (AASLD) radiographic criteria (Bruix Hepatology 2011). The criteria specifies CT or MRI intense arterial uptake followed by "washout" of contrast in the venous-delayed phases. Any atypical lesions must be confirmed by biopsy.
- A single liver lesion with tumor size ≥ 3 cm as defined as maximal diameter in the axial dimension on MRI. Included in the measurement are both enhancing and non-enhancing components of the lesion.
- Maximum tumor size of 7 cm as defined as maximal diameter in the axial dimension on MRI.
- Age ≥ 18 years
- Child-Pugh class A or B7 without ascites
- ECOG score 0
- No prior treatment of current HCC. However, recurrent HCC after resection may be included.
- Ability to understand and the willingness to sign a written informed consent document.
- Pregnancy which will be assessed via pregnancy test prior to TACE and repeated prior to SBRT.
- Metastatic disease outside of the liver
- Vascular invasion as evidenced by vessel occlusion or radiographic evidence of tumor thrombus.
- Contraindications to MRI, including claustrophobia, metallic implants, and pacemakers
- Tumor for which adequate radiation dosage cannot be safely delivered (see dose constraints below)
- Prior therapeutic radiation therapy to the abdomen and/or lower thorax as defined as below the carina to the pelvic inlet.
- Inability to provide informed consent based on persistent lack of understanding, inability to find adequate translation, impaired mental status such as mental retardation, drug induced, or traumatic brain injury.
- Multiple liver tumors making the patient a BCLC Stage B
- Prior treatment, except for surgical resection, to the lesion being targeted in the protocol.