Is NCT06058663 recruiting in Jacksonville, FL?

Yes, NCT06058663 is currently recruiting participants at its Jacksonville, FL location. This locally advanced intrahepatic cholangiocarcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Jacksonville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Locally Advanced Intrahepatic Cholangiocarcinoma Clinical Trial in Jacksonville, FL

Q: How do I join the locally advanced intrahepatic cholangiocarcinoma clinical trial in Jacksonville?

To join this clinical trial in Jacksonville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Locally Advanced Intrahepatic Cholangiocarcinoma Study in Jacksonville

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.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

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

Exclusion Criteria

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

Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade \>= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Jacksonville?

Yes, this clinical trial (NCT06058663) has an active research site in Jacksonville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Locally Advanced Intrahepatic Cholangiocarcinoma Treatment Options in Jacksonville, FL

If you're searching for locally advanced intrahepatic cholangiocarcinoma treatment options in Jacksonville, FL, this clinical trial (NCT06058663) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Jacksonville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced locally advanced intrahepatic cholangiocarcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all locally advanced intrahepatic cholangiocarcinoma clinical trials near you to find additional studies recruiting in your area.

Locally Advanced Intrahepatic Cholangiocarcinoma Clinical Trial in Jacksonville, FL

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