Atezolizumab and Bevacizumab With Proton Radiotherapy for Unresectable Hepatocellular Carcinoma

Exclusion Criteria

• •Prior invasive malignancy unless disease free for a minimum of 2 years
• •Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields
• •Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
• •Untreated active hepatitis B or hepatitis C
• •Moderate to severe or intractable ascites
• •Presence of distant metastases that cannot be encompassed by proton radiotherapy
• •Untreated or incomplete treated esophageal or gastric varices
• •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
• •Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
• •Prior solid organ transplantation.
• •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.
• •Prior or active thrombotic or bleeding disorders, hemoptysis, cerebral vascular accident, significant cardiac disease (ischemic or congestive heart failure), or gastrointestinal perforation.
• •Inability to treat all sites of disease by proton radiotherapy (such as extrahepatic metastases or massive liver tumors whereby the liver constraints \[ULV/SLV \>40%\] cannot be met for covering all sites of liver tumors using proton radiotherapy.)
• •Known HIV infection.