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Recruiting Phase 2 NCT05422690

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

Trial Parameters

Condition Intrahepatic Cholangiocarcinoma
Sponsor Inova Health Care Services
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 16
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-06-12
Completion 2026-09-30
Interventions
Induction Chemotherapy Triplet TherapyConcurrent Y-90 treatmentConsolidation Doublet Therapy:

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Adult males and females at least 18 years of age * Histologically and/or cytologically confirmed iCCA that is previously untreated or, if systemic therapy has been rendered for prior disease, has been administered at least 6 months before the development of recurrent or de novo new sites of disease. * Unresectable disease, as deemed by the Inova multidisciplinary tumor board (i.e. disease that cannot be safely resected with negative margins, leaving 2 adjacent segments of liver with intact portal venous and hepatic arterial inflow and intact biliary and hepatic venous outflow with the future liver remnant of sufficient volume to avoid postoperative liver insufficiency) * Measurable disease per RECIST 1.1 at least 2 cm in size * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Noncirrhotic liver - patients should not have a preexisting diagnosis of cirrhosis either diagnosed via biopsy or with features consistent with cirrhosis on imag

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