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 statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInova Health Care Services

About this trial

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

Qualifiers

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

Disqualifiers

Female patients who are pregnant or breast-feeding

History of allogeneic organ transplantation.

Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.

Patients with controlled type 1 diabetes on an insulin regimen are eligible for the study.

Trial design

Treatments tested in this trial

  • Induction Chemotherapy Triplet Therapy
  • Concurrent Y-90 treatment
  • Consolidation Doublet Therapy:

Treatment groups

16 Participants
are divided into 1 treatment group

Sponsors and collaborators