Actively Recruiting
Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio
Led by Beth Israel Deaconess Medical Center · Updated on 2026-04-22
30
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
Sponsors
B
Beth Israel Deaconess Medical Center
Lead Sponsor
S
Sirtex Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willingly sign the study consent form
- Male or female participants aged 18 years or older
- Confirmed diagnosis of locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma with at least one lesion in the liver
- Disease measurable or evaluable by CT or MRI scans according to RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Body weight greater than 30 kg
- Life expectancy of at least 12 weeks
- Adequate marrow function: hemoglobin at least 9.0 g/dL, absolute neutrophil count at least 1.0 x 10^9/L, platelet count at least 75 x 10^9/L
- Adequate kidney function with serum creatinine 1.5 mg/dL or less, or creatinine clearance above 40 mL/min
- Adequate liver function with bilirubin no more than 1.5 times the upper limit of normal (ULN), ALT and AST no more than 2.5 times ULN (or up to 5 times ULN if liver metastases present)
- No active hepatitis B or C infection; cured hepatitis C or controlled hepatitis B on therapy allowed
- Normal coagulation studies or acceptable if on anticoagulation approved by sponsor
- HIV-positive participants on stable effective antiretroviral therapy with undetectable viral load and sufficient CD4 count are eligible
You will not qualify if you...
- Disease that can be surgically removed at enrollment
- Diagnosis of primary liver cancer or mixed liver/bile duct cancer
- Prior systemic chemotherapy or radiotherapy for intrahepatic cholangiocarcinoma (except prior surgery and adjuvant therapy if more than 6 months ago and tumor suitable for Y-90)
- Prior treatment with anti-PD-1, anti-PD-L1 antibodies including durvalumab or other T-cell checkpoint inhibitors
- Serious heart conditions or stroke within 6 months before screening
- Previous cancers within 3 years except certain treated skin or in-situ cancers
- Severe chronic lung disease with baseline low oxygen levels
- Major surgery within 4 weeks before treatment start
- Active uncontrolled infection requiring systemic therapy
- Untreated HIV, hepatitis B, or hepatitis C infection
- Participation in another investigational drug or device study within 4 weeks before registration
- Pregnancy or breastfeeding, or unwillingness to use effective contraception
- Known allergy to any study drugs or their ingredients
- Contraindications to Y-90 radiation therapy as assessed by the treating doctor
- History of organ transplantation
- Active or prior autoimmune or inflammatory disorders, with some exceptions
- Uncontrolled illness or psychiatric conditions limiting study compliance
- Recent use of immunosuppressive medications not allowed except specific exceptions
- Receipt of live vaccines within 30 days before first study drug dose
- Other conditions posing unacceptable risk or interfering with study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
A
Andrea Bullock, MD, MPH
CONTACT
S
Selma Sinanovic, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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