Beth Israel Deaconess Medical Center
This trial is designed to study a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for bile duct cancer that cannot be removed with surgery. The specific names of the interventions that will be used are: * Y-90 (a type of radiation microsphere bead) * Durvalumab (a type of immunotherapy) * Gemcitabine (a type of chemotherapy) * Cisplatin (a type of chemotherapy)
This is a single arm Phase II, non-randomized, open-label clinical trial assessing the safety and efficacy of Y-90 SIRT in combination with durvalumab, gemcitabine and cisplatin in participants with locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma. The U.S. Food and Drug Administration (FDA) has approved durvalumab for bile duct cancer that cannot be removed with surgery, but it has been approved for other uses. The U.S. Food and Drug Administration (FDA) has already approved gemcitabine, cisplatin, and Y-90 microsphere radiation as a treatment option for bile duct…
Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study * Male and female participants at least 18 years of age at the time of signing the ICF * Histologically or cytologically confirmed locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma; at least one intrahepatic lesion must be present * Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria * ECOG performance status ≤1 * Body weight \>30 kg * Must have a life expectancy of at least 12 weeks * Participants must have adequate marrow function as de…
Intravenous infusion
Intravenous infusion
Intravenous infusion
Injection of radiation microsphere beads
Arctuva estimate
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