A Single Arm Phase 2 Study of Y-90 SIRT in Combination With Durvalumab (MEDI 4736) and Gemcitabine/Cisplatin in Locally Advanced, Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
Beth Israel Deaconess Medical Center
Summary
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)
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugGemcitabine
Intravenous infusion
- DrugCisplatin
Intravenous infusion
- DrugDurvalumab
Intravenous infusion
- RadiationYttrium-90
Injection of radiation microsphere beads
Location
- Beth Israel Deaconess Medical CenterBoston, Massachusetts