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)
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
Surgically resectable disease at enrollment
Histologically or cytologically confirmed diagnosis of primary hepatocellular carcinoma or mixed adenocarcinoma/hepatocellular carcinoma
Received prior systemic chemotherapy and/or radiotherapy for intrahepatic cholangiocarcinoma. Prior surgical resection and adjuvant chemotherapy or chemoradiotherapy is allowed if more than 6 months have elapsed since last dose of treatment, and if the tumor is amenable to Y-90 SIRT
Prior treatment with anti-PD-1, anti-PD-L, including durvalumab antibody, or any other drug treatment specifically targeting T-cell co-stimulation or checkpoint pathways
Beth Israel Deaconess Medical Center
Lead sponsor
Sirtex Medical
Collaborator
Dana-Farber Cancer Institute
Collaborator