Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer
Trial Parameters
Brief Summary
This research study is studying a combination of drugs as a possible treatment for Hepatocellular Carcinoma or Biliary Tract Cancer. The interventions involved in this study are: * Durvalumab * Tremelimumab * Radiation Therapy
Eligibility Criteria
\*\*After activation of a protocol amendment on July 14, 2022, only participants with biliary tract cancer will be permitted to enroll.\*\* Inclusion Criteria: * Histologically or cytologically confirmed hepatocellular carcinoma or biliary tract cancer * Locally advanced/unresectable or metastatic disease * Age ≥ 18 years at time of study entry * ECOG Performance Status ≤ 1 * One previously unirradiated lesion amenable to 8 Gy x 3 radiotherapy based on dosimetric organ tolerance AND another unirradiated measurable lesion (per irRECIST) outside of the radiation field * Immunotherapy-naïve * Progressed on, be intolerant of, or refused sorafenib \[for HCC\], second line treatment and beyond for cholangiocarcinoma or gemcitabine-based chemotherapy for biliary tract cancer * The benefits of sorafenib have been discussed with the patient and the patient has refused treatment with sorafenib. * Viral status (Hepatitis B and C) must be known. All HBV-positive patients must be on antiviral medic