vGRID SBRT: A Phase I Clinical Trial in Unresectable or Metastatic HCC
This trial will provide the maximum tolerated dose for radiation therapy for liver tumors and describe the toxicity profile using the vGRID therapy technique. Based on trials using this type of radiation in other cancers demonstrating low toxicity rates even with very high radiation doses and high efficacy, it is likely that vGRID therapy in this trial will be well tolerated and allow dose escalation beyond currently common doses for liver tumors.
• Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent .
• Males and females age ≥ 18 years.
• ECOG Performance Status 0 - 1
• Histologically confirmed hepatocellular carcinoma (HCC) or mixed HCC and cholangiocarcinoma either locally advanced or metastatic.
• Not a candidate for surgical resection, or transplant
• Child Pugh A - B7 liver function scale classification 14 days prior to entry.
• Unresectable, locally-advanced or metastatic hepatocellular carcinoma. Meets normal liver and adjacent organ radiation dose constraints, which usually corresponds to tumor sizes 4 - 12 cm in diameter. Tumors that are larger than 12cm are permitted provided radiation dose constraints to adjacent normal tissue are met per radiation dose constraint table
• Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to initiating study intervention. Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use an acceptable form of contraception for the duration of study participation, and for at least 12 months following completion of therapy. Men of child-bearing potential must agree not to donate sperm while on this study and for at least 12 months after their last study treatment.
• Adequate organ function, defined as follows: Result Date
• Hemoglobin ≥8 g/dL (The use of transfusion is acceptable)
⁃ Absolute Neutrophil Count \> 1.0 K/UL
⁃ Platelets \> 50 K/UL
⁃ AST and ALT \< 6 times upper limit of normal (ULN)
⁃ Albumin \>2.9g/dl
⁃ Prothrombin/INR \< 1.7
⁃ Creatinine \< 1.5x ULN or creatinine clearance \> 60 mL/min
⁃ Total Bilirubin \< 3.0
⁃ Esophageal varices, if present, must be \< Grade 2 and can not have had bleeding in the last 6 months. If clinically indicated, a standard care Esophageal Gastric Duodenoscopy (EGD) is recommended to rule out uncontrolled esophageal varices. NOTE: EGD is not required for enrollment.
⁃ Documented virology status of hepatitis, as confirmed by HBV / HCV serology test. Patients with known hepatitis are allowed on this study provided they meet all other eligibility criteria. Concomittant therapy for hepatitis is permitted at the principal investigator's discretion.
⁃ No known history or suspected human immunodeficiency virus (HIV). Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ (350) cells/microliter, and no known detectable viral load, at the time of study entry. Note also that HIV testing is not required for eligibility for this protocol.