Study on Y-90 Radiation, Durvalumab, Gemcitabine, and Cisplatin for Bile Duct Cancer

Sponsor: Beth Israel Deaconess Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05655949

Provider View

This clinical trial is exploring a new treatment combination for bile duct cancer that cannot be removed with surgery. It includes radiation, immunotherapy, and chemotherapy to see if it can help control the disease.

Patient Parameters

Program Overview

This study is testing a combination of treatments for bile duct cancer that cannot be surgically removed. The treatments include Y-90 radiation beads, the immunotherapy drug Durvalumab, and the chemotherapy drugs Gemcitabine and Cisplatin. The goal is to see if this combination is safe and effective in treating the cancer.

Description

This trial is a Phase II study, meaning it focuses on assessing the safety and effectiveness of the treatment. It involves using Y-90 radiation beads along with Durvalumab, Gemcitabine, and Cisplatin in patients with advanced bile duct cancer that cannot be removed by surgery. The study will include about 30 participants who will undergo various evaluations and follow-up visits over a period of up to 52 weeks. The study is supported by AstraZeneca, which provides Durvalumab and funding, and Sirtex, which provides the Y-90 radiation beads.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Must be 18 years or older.
  • Must have advanced bile duct cancer that cannot be removed by surgery, with at least one tumor in the liver.
  • Must have cancer that can be measured by scans.
  • Must be in good general health with a performance status of 0 or 1.
  • Must weigh more than 30 kg.
  • Must have a life expectancy of at least 12 weeks.
  • Must have adequate blood cell counts and organ function, including:
    • Hemoglobin level of at least 9.0 g/dL.
    • Neutrophil count of at least 1.0 x 10^9/L.
    • Platelet count of at least 75 x 10^9/L.
    • Normal kidney and liver function as indicated by specific blood tests.
  • Must not have active hepatitis B or C infections, but those with controlled infections may be eligible.
  • Must have normal blood clotting times unless on stable anticoagulation.
  • HIV-positive patients may be eligible if they meet specific criteria, including stable treatment and undetectable viral load.

Exclusion Criteria

  • Cancer that can be surgically removed.
  • Diagnosis of primary liver cancer or mixed cancer types.
  • Previous chemotherapy or radiation for bile duct cancer, unless it was more than 6 months ago.
  • Previous treatment with certain immunotherapy drugs.
  • Recent severe heart problems, stroke, or unstable heart conditions.
  • Other cancers within the last 3 years, except for certain skin or in-situ cancers.
  • Severe lung diseases or recent major surgery.
  • Active infections requiring treatment.
  • Active, untreated HIV, hepatitis B, or C.
  • Participation in another study within the last 4 weeks.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • Known allergies to study drugs.
  • Any condition that could interfere with the study or pose a risk to the participant.

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