RecruitingPhase 2NCT05422690

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

A Phase II Single-center, Open-label, Single Arm Study of Induction Gemcitabine, Cisplatin and Durvalumab Followed by Gemcitabine, Cisplatin and Yttrium-90 (Y-90) Radioembolization for the Treatment of Locally Advanced Unresectable Intrahepatic Cholangiocarcinoma


Sponsor

Inova Health Care Services

Enrollment

16 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining standard chemotherapy (gemcitabine + cisplatin) and immunotherapy (durvalumab) with a targeted liver procedure called Y-90 (yttrium-90 radioembolization, which delivers radiation directly into liver tumors) works better than chemotherapy and immunotherapy alone for bile duct cancer that cannot be removed surgically. **You may be eligible if:** - You are at least 18 years old - You have been diagnosed with intrahepatic cholangiocarcinoma (bile duct cancer inside the liver) confirmed by biopsy - Your cancer cannot be surgically removed - Your cancer has not spread outside the liver (except nearby lymph nodes) - You have not previously received treatment for this cancer, or your previous treatment was at least 6 months ago - Your liver does not have cirrhosis - Your overall health and organ function are adequate **You may NOT be eligible if:** - You are pregnant or breastfeeding - Your cancer has spread to other organs beyond nearby lymph nodes - Your liver is cirrhotic - You cannot tolerate the procedures involved in the trial 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

DRUGInduction Chemotherapy Triplet Therapy

Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 infused on both day 1 and day 8 of a 21-day cycle. Durvalumab 1500 mg will be given on day 1 of each cycle.

RADIATIONConcurrent Y-90 treatment

Patients will undergo a Y-90 treatment planning consultation by the treating interventional radiologist during cycle 1. One or two cycles (depending on tumor size) of cisplatin, 25 mg/m2 and gemcitabine 300 mg/m2 given on day 1 and day 8 in combination with Yttrium-90 (Y-90) microspheres which will be given on day 3-7 or day 10-21 at the discretion of the interventional radiologist, separated in time by at least 2 days from a chemo infusion during that cycle

DRUGConsolidation Doublet Therapy:

Gemcitabine 1000 mg/m2 and Cisplatin 25 mg/m2 given on days 1 and 8 of a 21-day cycle with durvalumab 1500 mg given on day 1 of each cycle for 3-5 additional cycles. For the cycle directly after Y-90, gemcitabine will be kept at a dose of 300 mg/m2 to minimize risk of toxicity.


Locations(1)

Keary Janet

Fairfax, Virginia, United States

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NCT05422690


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