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

Study Name
	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
ClinicalTrials.gov Identifier (if applicable)
	NCT05655949
Clinical Trial Category (check all that apply)
	First Line Therapy Chemotherapy Immunotherapy Radiation Therapy
Study Center
Institution Name
	Beth Israel Deaconess Medical Center
Institution Address
	330 Brookline Avenue
City
	Boston
State
	Massachusetts
Zip Code
	02215
Country
	United States
Phone
	(617) 667-2100
Website
	https://www.bidmc.org/centers-and-departments/cancer-center/cancer-center-programs-and-services/gastrointestinal-cancer-program/gi-cancer-clinical-trials
Study Contacts
Principal Investigator
	Andrea Bullock
P.I. Phone
	(617) 667-2100
P.I. Email
	abullock@bidmc.harvard.edu
List additional Principal Investigators (include phone number and email)
	Ammar Sarwar, MD asarwar@bidmc.harvard.edu
Study Coordinator
	John Msaddi
Study Coordinator Phone
	(617) 975-7463
Study Coordinator Email
	jmsaddi@bidmc.harvard.edu
List additional Study Coordinators (include phone number and email)
	Selma Sinanovic ssinanov@bidmc.harvard.edu (617) 975-7456
OVERVIEW – in layman’s terms (150 words max)
	This trial evaluates a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for advanced unresectable and metastatic intrahepatic cholangiocarcinoma. In this study patients will be treated with gemcitabine/cisplatin, durvalumab, and yttrium-90 selective internal radiotherapy.
Enrollment
	30 participants
Study Start Date
	02/01/2023
Estimated Completion Date
	12/01/2024
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	to assess the safety and efficacy of Gemcitabine + Cisplatin + Durvalumab + Yttrium-90 Selective Internal Radiation Therapy
Inclusion Criteria – Patients Must:
	previously untreated unresectable or metastatic intrahepatic cholangiocarcinoma with at least one intrahepatic lesion visible measurable disease per RECIST v1.1 ECOG performance status </=1 adequate bone marrow, kidney and liver function body weight >30kg
Exclusion Criteria – Patients Must NOT:
	surgically resectable disease at enrollment 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
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
	History and Physical Exam CT, MRI or PET-CT Collection of archival tumor tissue Radiation planning
POTENTIAL SIDE-EFFECTS – in layman’s terms
	fatigue nausea low blood counts fever diarrhea rash joint aches nerve damage autoimmune effects liver injury