Actively Recruiting
The Purpose of This Research Study is to See if Combining Gemcitabine, Cisplatin and Durvalumab Chemotherapy Treatments With a Direct Tumor Therapy Yittrium-90 (Y-90) Will Work Better Together to Shrink Tumors and Control Cancer
Led by Inova Health Care Services · Updated on 2025-07-10
16
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research is to see if combining gemcitabine, cisplatin and Durvalumab chemotherapy treatments with a direct tumor therapy called Yittrium-90, will work better together to shrink the tumor and control cancer.
CONDITIONS
Official Title
The Purpose of This Research Study is to See if Combining Gemcitabine, Cisplatin and Durvalumab Chemotherapy Treatments With a Direct Tumor Therapy Yittrium-90 (Y-90) Will Work Better Together to Shrink Tumors and Control Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males and females at least 18 years of age
- Histologically and/or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA), untreated or treated at least 6 months prior to recurrence
- Disease deemed unresectable by multidisciplinary tumor board
- Measurable tumor of at least 2 cm by RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Noncirrhotic liver with Child-Pugh score less than 5
- No evidence of extrahepatic disease except regional lymph nodes planned for surgery
- Adequate organ function per laboratory values
- Ability to complete study testing
- Able and willing to provide informed consent
You will not qualify if you...
- Female patients who are pregnant or breastfeeding
- History of allogeneic organ transplantation
- Active or history of autoimmune disease or immune deficiency, except controlled hypothyroidism, type 1 diabetes on insulin, vitiligo, alopecia, chronic skin conditions without systemic therapy, or inactive autoimmune disease for 5 years after physician consultation
- Use of immunosuppressive medication within 14 days before starting durvalumab, except certain steroids
- Child-Pugh B7 or higher cirrhosis
- Extrahepatic or perihilar cholangiocarcinoma
- Gallbladder, pancreatic, or ampullary cancer
- Portal vein thrombosis involving major portal vein branches
- Extrahepatic disease outside regional lymph nodes
- Previous chemotherapy, intra-arterial, or radiotherapy for iCCA, except adjuvant capecitabine
- Contraindications to durvalumab, gemcitabine, or cisplatin
- Active hepatitis B or C without treatment agreement
- Contraindications found on angiography including significant lung shunting or non-manageable extrahepatic deposition
- Hepatic tumor burden over 75%
- Inability to protect non-target arteries during radioembolization
- Serum albumin below 3 g/dL
- Serum bilirubin above 2 mg/dL or very high liver enzymes
- Any illness or condition posing added risk or preventing adequate assessment
- Life-threatening intercurrent illness
- Anticipated poor compliance
- Prisoners or involuntarily incarcerated individuals
- Cognitive impairment or decisional incapacity
- Any severe illness or condition making the patient unsuitable as judged by investigator
- Enrollment in another interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Keary Janet
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
K
Keary Janet, BS
CONTACT
E
Elahe Mollapour
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here