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

NCT05655949

Institution Name

Beth Israel Deaconess Medical Center

Full Institution Address

330 Brookline Avenue Boston Massachusetts 02215

Institution Phone

(617) 667-2100

Institution Website

https://www.bidmc.org/centers-and-departments/cancer-center/cancer-center-programs-and-services/gastrointestinal-cancer-program/gi-cancer-clinical-trials

Principal Investigator

Andrea Bullock

Principal Investigator Phone

(617) 667-2100

Principal Investigator Email

abullock@bidmc.harvard.edu

Additional Principal Investigators

Ammar Sarwar, MD asarwar@bidmc.harvard.edu

Study Coordinator

John Msaddi

Study Coordinator Phone

(617) 975-7463

Study Coordinator Email

jmsaddi@bidmc.harvard.edu

Additional Study Coordinators

Selma Sinanovic ssinanov@bidmc.harvard.edu (617) 975-7456

Study Overview

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 Information

30 participants

Study Start Date

20230201

Study End Date

20241201

Study Purpose

to assess the safety and efficacy of Gemcitabine + Cisplatin + Durvalumab + Yttrium-90 Selective Internal Radiation Therapy

Inclusion Criteria

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

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 Study

History and Physical Exam CT, MRI or PET-CT Collection of archival tumor tissue Radiation planning

Potential Side Effects

fatigue nausea low blood counts fever diarrhea rash joint aches nerve damage autoimmune effects liver injury

Financial Assistance Available

Yes

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