Spots Global Cancer Trial Database for Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio

Study Description

Brief Summary: 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)

Detailed Description: This is a single arm Phase II, non-randomized, open-label clinical trial assessing the safety and efficacy of Y-90 SIRT in combination with durvalumab, gemcitabine and cisplatin in participants with locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma. The U.S. Food and Drug Administration (FDA) has approved durvalumab for bile duct cancer that cannot be removed with surgery, but it has been approved for other uses. The U.S. Food and Drug Administration (FDA) has already approved gemcitabine, cisplatin, and Y-90 microsphere radiation as a treatment option for bile duct cancer that cannot be removed with surgery. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will be followed for up to 52 weeks if taken off protocol therapy. It is expected that about 30 people will take part in this research study. AstraZeneca, a pharmaceutical company, is supporting this research study by providing one of the study drugs, durvalumab, as well as providing research funding. Sirtex, a medical device company, is supporting this research by providing the Y-90 radiation microsphere beads.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial