RecruitingPhase 2NCT05655949

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


Sponsor

Beth Israel Deaconess Medical Center

Enrollment

30 participants

Start Date

Feb 13, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of treatments for people with intrahepatic cholangiocarcinoma (bile duct cancer that starts inside the liver) that cannot be surgically removed. The combination includes a targeted internal radiation treatment called Y-90 radioembolization, plus immunotherapy (durvalumab), and chemotherapy (gemcitabine and cisplatin). **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of advanced or spreading bile duct cancer (intrahepatic cholangiocarcinoma) - You have at least one measurable liver tumor - Your overall health is adequate (ECOG 0–1) - Your body weight is above 30 kg - Your blood counts, kidney function, and other lab values are within acceptable ranges - You have a life expectancy of at least 12 weeks **You may NOT be eligible if...** - Your cancer is not located inside the liver - Your overall health is too poor to receive this intensive combination treatment - Your blood or organ function is significantly impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine

Intravenous infusion

DRUGCisplatin

Intravenous infusion

DRUGDurvalumab

Intravenous infusion

RADIATIONYttrium-90

Injection of radiation microsphere beads


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT05655949


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