Combination Chemoembolization and Stereotactic Body Radiation Therapy in Unresectable Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: SBRT; TACE
Intervention description: Radiation is to be delivered to 30-45 Gy in 5 fractions. 40 Gy in 5 fractions will be utilized, unless dose constraints preclude it. Treatment will optimally be delivered every other day with no more than 3 fractions per week. The ideal treatment team will be less than 15 total days.; two sessions of standard TACE with ethiodol separated by a 4-week interval.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatocellular Carcinoma; Trans-Arterial Chemoembolization; Stereotactic Body Radiation Therapy; HCC; TACE; SBRT

Summary:

      The purpose of this study is to develop better ways to treat liver cancer, known as
      hepatocellular carcinoma or HCC, while it is still in the liver. Many treatments exist to
      treat tumors in the liver when they are small but after they grow past a certain size, local
      therapies such as surgery, Trans-Arterial Chemo Embolization (TACE), or Radiofrequency
      Ablation (RFA) are not effective. The purpose of this study to test the combination of two
      known treatments - TACE and Stereotactic Body Radiation Therapy (SBRT) - to be used together
      to treat larger or difficult to access liver tumors. Each treatment has been shown to work
      well but has limitations. The study will combine the treatments in an organized sequence and
      monitor closely how effective this combination controls tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.