| ClinicalTrials.gov Identifier |
| NCT05655949 |
| Institution Name |
| Beth Israel Deaconess Medical Center |
| Institution Address (Street) |
| 330 Brookline Avenue |
| Institution City |
| Boston |
| Institution State |
| Massachusetts |
| Institution ZIP Code |
| 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 |
|
| 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 |
