Actively Recruiting
Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma
Led by Mayo Clinic · Updated on 2026-05-13
16
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial tests the safety and side effects of yttrium-90 (Y90) radioembolization combined with immunotherapy drugs tremelimumab and durvalumab in treating patients with intrahepatic cholangiocarcinoma (cancer of the bile ducts in the liver) that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable) who are not candidates for curative therapy or that has spread from where it first started (primary side) to multiple other places in the body (oligo-metastatic). Cholangiocarcinoma is a rare but aggressive cancer with limited curative options outside of surgery. Immunotherapy has shown modest benefit in hepatobiliary (liver, bile ducts, and gallbladder) cancers including cholangiocarcinoma. Radioembolization is a type of radiation therapy used to treat liver cancer that is advanced or has come back where tiny beads that hold the radioactive substance (radioisotope) yttrium Y90 are injected into or near the hepatic artery (the main blood vessel that carries blood to the liver). The beads collect in the tumor and the Y90 gives off radiation. This destroys the blood vessels that the tumor needs to grow and kills the tumor cells. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving Y90 radioembolization in combination with tremelimumab and durvalumab immunotherapy may be safe and beneficial in treating patients with locally advanced, unresectable or oligo-metastatic intrahepatic cholangiocarcinoma who are not candidates for curative therapy.
CONDITIONS
Official Title
Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with body weight over 30 kg
- Histologically or cytologically confirmed locally advanced intrahepatic cholangiocarcinoma not suitable for surgery, transplantation, or thermal ablation
- Oligometastatic intrahepatic cholangiocarcinoma with specific limits on lymph node or organ metastases
- Measurable disease
- ECOG performance status of 0 or 1
- Hemoglobin level of at least 9.0 g/dL within 14 days before registration
- Absolute neutrophil count of at least 1000/mm^3 within 14 days before registration
- Platelet count of at least 75,000/mm^3 within 14 days before registration
- Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), with exceptions for Gilbert disease, measured within 14 days before registration
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) levels less than or equal to 5 times ULN within 14 days before registration
- Creatinine clearance of at least 40 ml/min within 14 days before registration
- International normalized ratio (INR) less than or equal to 1.6, with exceptions for anticoagulation therapy
- Adequate hepatic function: Child Pugh A and albumin-bilirubin (ALBI) grade 1 or 2
- Patients with hepatitis B or C must meet specific viral load and treatment criteria
- Negative pregnancy test within 7 days before registration for persons of childbearing potential
You will not qualify if you...
- Participation in another clinical study except observational studies or follow-up periods
- Surgery within 28 days before registration
- Chemotherapy within 4 weeks before registration
- More than one prior systemic therapy for cholangiocarcinoma (except certain adjuvant therapies)
- Unresolved toxicity grade 2 or higher from prior cancer treatments, with some exceptions
- History of previous locoregional therapy or therapeutic cancer vaccines
- Unstable liver function or worsening Child Pugh or ALBI scores
- Inability to undergo mapping angiography or unsuitable tumor blood supply for transarterial therapy
- Lung shunt fraction exceeding safety limits
- Serious concurrent illnesses or systemic diseases that interfere with safety assessment
- Immunocompromised patients or those with HIV on antiretroviral therapy
- Active or uncontrolled autoimmune or inflammatory disorders
- History of other primary malignancies except certain adequately treated cancers
- Uncontrolled infections or serious chronic illnesses
- Psychiatric or social conditions limiting compliance or informed consent
- History of leptomeningeal carcinomatosis or allogeneic transplantation
- Use of immunosuppressive medication within 14 days before registration with specified exceptions
- Allergy or hypersensitivity to study drugs
- Receiving other investigational treatments for the primary cancer
- Pregnant or lactating women
- Life expectancy under 3 months
- Intolerance to contrast agents not manageable by medical treatment
- Primary immunodeficiency
- Inability to provide informed consent
- Recent live attenuated vaccine within 30 days before registration
- Progressive disease on prior immunotherapy with durvalumab or pembrolizumab
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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