NCT05655949

Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio

A Single Arm Phase 2 Study of Y-90 SIRT in Combination With Durvalumab (MEDI 4736) and Gemcitabine/Cisplatin in Locally Advanced, Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bile Duct Cancer
• Cholangiocarcinoma
• Cholangiocarcinoma Non-resectable
• Cholangiocarcinoma Metastatic
• Metastatic Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	Intravenous infusion
DRUG	Cisplatin	Intravenous infusion
DRUG	Durvalumab	Intravenous infusion
RADIATION	Yttrium-90	Injection of radiation microsphere beads

Timeline

• Start date: 2024-02-13
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2022-12-19
• Last updated: 2025-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study