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
Single group
Gemcitabine
DrugIntravenous infusion
Cisplatin
DrugIntravenous infusion
Durvalumab
DrugIntravenous infusion
Yttrium-90
RadiationInjection of radiation microsphere beads
Median Progression Free Survival (PFS)
PFS is defined as the time from date of entry into the study until the date of disease progression (according to RECIST v1.1 and assessed by an independent central reviewer) or death, whichever occurs first.
Incidence of Grade 3 or Higher Treatment-Related Toxicity
All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms. Incidence is the number of patients experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation.
Median Overall Survival (OS)
OS is based on Kaplan-Meier method and defined as the time from date of entry into the study until the date of death.
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with the best overall response of complete response or partial response according to RECIST v1.1 criteria as assessed by an independent central reviewer"
Disease Control Rate (DCR)
DCR is defined as the proportion of participants with the best overall response of complete response, partial response, or stable disease according to RECIST v1.1 criteria as assessed by an independent central reviewer
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Beth Israel Deaconess Medical Center
Lead sponsor
Sirtex Medical
Collaborator
Dana-Farber Cancer Institute
Collaborator
