Photon Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC

Exclusion Criteria

• •1. Prior invasive malignancy unless disease free for a minimum of 2 years
• •2. Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields
• •3. Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
• •4. Untreated active hepatitis B or hepatitis C
• •5. Moderate to severe or intractable ascites
• •6. Presence of distant metastases that cannot be encompassed by photon radiotherapy
• •7. Untreated or incomplete treated esophageal or gastric varices
• •8. Severe, active co-morbidity, defined as follows:
• •* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
• •* Myocardial infarction within the last 6 months prior to study entry
• •* Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry
• •* A bleeding episode within 6 months prior to study entry due to any cause.
• •* Thrombolytic therapy within 28 days prior to study entry.
• •* Known bleeding or clotting disorder.
• •* Uncontrolled psychotic disorder
• •9. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
• •10. Prior solid organ transplantation.
• •11. Prior or active autoimmune disease (AID) including autoimmune hepatitis, inflammatory bowel disease, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, and multiple sclerosis.
• •12. Inability to treat all sites of disease by photon radiotherapy (such as extrahepatic metastases or massive liver tumors whereby the liver constraints cannot be met for covering all sites of liver tumors using photon radiotherapy.)
• •13. Known HIV infection.