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Y90 Radioembolization with Tremelimumab and Durvalumab for Advanced Intrahepatic Cholangiocarcinoma

This study is testing a new combination treatment for intrahepatic cholangiocarcinoma (a type of bile duct cancer in the liver) that has spread locally or to a few other places, and cannot be removed by surgery. The treatment combines yttrium-90 (Y90) radioembolization, which delivers radiation directly to the tumor, with two immunotherapy drugs, tremelimumab and durvalumab. Immunotherapy helps your body's immune system fight cancer. Researchers want to see how safe this combination is and what side effects it might cause. They also want to see how well it shrinks tumors and helps people live longer. You might be able to join if you are at least 18 years old and have this type of cancer that is locally advanced and unresectable, or oligometastatic (spread to a few other places). The study plans to enroll 16 participants, but its current status is unclear.

Study design
This is a phase I interventional study, meaning it's an early-stage trial focused on safety. It plans to enroll 16 participants to test the combination treatment.
What's involved
You would undergo procedures like angiography, biopsy, blood sample collection, and CT scans. The specific duration of these commitments is not detailed in the record.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured at Day 0 to day 28 for Cohort 1, and Day 14 to day 42 for Cohort 2.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06058663

Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Mayo Clinic
~16 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:AngiographyBiopsyBiospecimen CollectionComputed TomographyDurvalumabMagnetic Resonance Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (Cohort 1)
Measured over Day 0 to day 28
+1 more outcome measured

Conditions

Locally Advanced Intrahepatic Cholangiocarcinoma
Oligometastatic Intrahepatic Cholangiocarcinoma
Stage III Intrahepatic Cholangiocarcinoma AJCC v8
Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
Unresectable Intrahepatic Cholangiocarcinoma

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Intrahepatic Cholangiocarcinoma

NCT06058663

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Florida

    Jacksonville, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Umair Majeed, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Age \>= 18 years with body weight \> 30 kg
Histologically or cytologically confirmed, locally advanced intrahepatic cholangiocarcinoma that is not amenable to resection, transplantation, or thermal ablation. Oligometastatic intrahepatic cholangiocarcinoma is also eligible. Specifically, such patients must have EITHER =\< 3 malignant extrahepatic lymph nodes (short axis diameter \>= 3cm) OR metastatic lesions in one organ other than liver (if only single lesion is present diameter MUST be \< 3cm, if up to 3 lesions in one organ each lesion MUST be =\< 1cm)
Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Hemoglobin \>= 9.0 g/dL (=\< 14 days prior to registration)
Absolute neutrophil count (ANC) \>= 1000/mm\^3 (=\< 14 days prior to registration)
Platelet count \>= 75,000/mm\^3 (=\< 14 days prior to registration)
Total bilirubin =\< 1.5 x upper limit of normal (ULN) (patients with known Gilbert disease who have serum bilirubin level 3 x ULN may be enrolled) (=\< 14 days prior to registration)
Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 5 x ULN (=\< 14 days prior to registration)
Calculated creatinine clearance \>= 40 ml/min using the Cockcroft- Gault formula or measured creatinine clearance \> 40 ml/min (=\< 14 days prior to registration)
International normalized ratio (INR) =\< 1.6. Note: INR prolongation due
Anticoagulation (INR \>= 2.0 but =\< 3.0)) for prophylaxis in patients without liver cirrhosis could be exception
Adequate hepatic function Child Pugh A and albumin-bilirubin (ALBI) 1 or 2
Patients with concurrent hepatitis B (HBV) or hepatitis C virus (HCV) infection should meet the following criteria:
Patient with HBV or should be monitored for viral levels during study participation
Patient with detectable hepatitis B surface antigen (HBsAg) or detectable HBV DNA should have HBV DNA \< 100 IU/ml and should be managed per local guidelines
Controlled hepatitis B subjects will be allowed if they have started treatment prior to or by the time point of enrollment into the study and treatment is continued during study participation and for \>= 6 months after end of study treatment
Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
Negative urine pregnancy test done prior =\< 7 days registration, for persons of childbearing potential only
NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Patients with grade \>= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician
Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physician
History of previous locoregional therapy
Previous use of therapeutic cancer vaccines
Unstable liver function and/ or a change in Child Pugh score during screening
Child Pugh B or greater
ALBI grade \> 2
Model for End-Stage Liver Disease (MELD) \> 10
Patient is unable to undergo mapping angiography or mapping angiography demonstrates tumor blood supply that does not lend itself to transarterial therapy
A lung shunt fraction greater than 30 Gy within a single session, or cumulative does greater than 50Gy
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
Active or uncontrolled autoimmune or inflammatory disorders (including Inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, granulomatosis with polyangiitis, sarcoidosis, Grave's disease)
History of another primary malignancy except for:
Malignancy treated with curative intent and with no known active disease \>= 5 years prior to registration and of low potential of recurrence
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated carcinoma in situ without evidence of disease
Uncontrolled intercurrent illness including, but not limited to:
Ongoing uncontrolled infections including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis (TB) testing in line with local practice), human immunodeficiency virus (HIV), hepatitis B and hepatitis C
Serious chronic gastrointestinal condition associated with diarrhea
Symptomatic congestive heart failure
Unstable angina pectoris, cardiac arrhythmia and uncontrolled hypertension
Chronic pulmonary disease including interstitial lung disease requiring oxygen
Psychiatric illness/social situations limiting compliance that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent
Uncontrolled hypertension
History of leptomeningeal carcinomatosis
History of allogeneic transplantation
Current or prior use of immunosuppressive medication \< 14 days before registration. The following are exceptions to this criterion:
Intranasal, inhaled, topical steroids, or local steroid injections
Systemic corticosteroids at physiologic doses not to exceed 10mg/day of
Prednisone or its equivalent
Known allergy or hypersensitivity to durvalumab and tremelimumab or any of the constituents of the products
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Pregnant or lactating female
Life expectancy \< 3 months
Intolerance to contrast agents that is refractory to medical management
Any other condition which the investigator believes would make participation in the study not acceptable
History of primary immunodeficiency
Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts
Receipt of live attenuated vaccine \< 30 days prior to registration and without need to receive any live attenuated vaccines during study conduct and for up to 30 days after end of durvalumab treatment or 90 days after end of tremelimumab treatment respectively
Prior immunotherapy such as durvalumab or pembrolizumab is allowed as long as patient does not have progressive disease on it

Exclusion

Concurrent enrollment in another clinical study, unless it is an observational clinical study or during the follow up period of an interventional study
Surgery =\< 28 days prior to registration
Chemotherapy =\< 4 weeks prior to registration
History of \> 1 prior systemic therapy for cholangiocarcinoma not including that in the adjuvant setting. Patients who progressed during or =\< 6 months from completion of adjuvant therapy are excluded

What this trial measures

  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (Cohort 1)Day 0 to day 28

    Dose-limiting toxicities (DLTs) will be defined as an adverse event (AE) attributed as definitely, probably, or possibility related to the study treatment in the first cycle. All the relevant results pertaining to toxicity will be examined in an exploratory and hypothesis-generating fashion. The number and severity of all adverse events will be tabulated and summarized in this patient population. The grade 3+ AEs will also be described and summarized in a similar fashion. Toxicity is defined as AEs that are classified as either possibly, probably, or definitely related to study treatment. Non-hematologic toxicities will be evaluated via the ordinal Common Terminology Criteria (CTC) standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity will be explored and summarized.

  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (Cohort 2)Day 14 to day 42

    DLTs will be defined as an AE attributed as definitely, probably, or possibility related to the study treatment in the first cycle. All the relevant results pertaining to toxicity will be examined in an exploratory and hypothesis-generating fashion. The number and severity of all adverse events will be tabulated and summarized in this patient population. The grade 3+ AEs will also be described and summarized in a similar fashion. Toxicity is defined as AEs that are classified as either possibly, probably, or definitely related to study treatment. Non-hematologic toxicities will be evaluated via the ordinal CTC standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity will be explored and summarized.