Fairfax, VANCT05422690Now EnrollingIRB Ready

Intrahepatic Cholangiocarcinoma Clinical Trial in Fairfax, VA

Access cutting-edge intrahepatic cholangiocarcinoma treatment through this clinical trial at a research site in Fairfax. Study-provided care at no cost to qualified participants.

Sponsored by Inova Health Care Services

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Expert Care in Fairfax

Access intrahepatic cholangiocarcinoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related intrahepatic cholangiocarcinoma treatment provided free

Apply for This Fairfax Location

Check if you qualify for this intrahepatic cholangiocarcinoma clinical trial in Fairfax, VA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Fairfax

    Convenient for VA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Fairfax site if eligible
  4. 4Begin participation

About This Intrahepatic Cholangiocarcinoma Study in Fairfax

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.

Sponsor: Inova Health Care Services

Who Can Participate

Inclusion Criteria

Adult males and females at least 18 years of age
Histologically and/or cytologically confirmed iCCA that is previously untreated or, if systemic therapy has been rendered for prior disease, has been administered at least 6 months before the development of recurrent or de novo new sites of disease.
Unresectable disease, as deemed by the Inova multidisciplinary tumor board (i.e. disease that cannot be safely resected with negative margins, leaving 2 adjacent segments of liver with intact portal venous and hepatic arterial inflow and intact biliary and hepatic venous outflow with the future liver remnant of sufficient volume to avoid postoperative liver insufficiency)
Measurable disease per RECIST 1.1 at least 2 cm in size
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Noncirrhotic liver - patients should not have a preexisting diagnosis of cirrhosis either diagnosed via biopsy or with features consistent with cirrhosis on imaging (e.g. shrunken liver with nodularity consistent with cirrhosis). Child-Pugh score must be less than 5.
No evidence of extrahepatic disease, except for regional adenopathy that would be resected as part of a standard oncologic surgical procedure
Adequate organ function as indicated by the following laboratory values (Table 1)
Ability to complete testing in the protocol
Able and willing to consent to protocol

Exclusion Criteria

Female patients who are pregnant or breast-feeding
History of allogeneic organ transplantation.
Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
Patients with controlled type 1 diabetes on an insulin regimen are eligible for the study.
Patients with vitiligo or alopecia.
Any chronic skin condition that does not require systemic therapy.
Patients without an active autoimmune disease in the last 5 years may be included but only after consultation with the study physician.
Patients with diet controlled celiac disease.
Current or recent use of immunosuppressive medication within 14 days before durvalumab initiation except if:
Intranasal, inhaled, topical or local steroid injections
Systemic corticosteroids at physiologic doses that do not exceed 10 mg/day of prednisone or its equivalent.
Steroids as premedication for hypersensitivity reactions, (i.e. CT scan premedication).
Child-Pugh B7 or greater cirrhosis
Extrahepatic or perihilar cholangiocarcinoma
Gallbladder cancer
Pancreatic or ampullary cancer
Portal vein thrombosis involving the main portal vein or first order right or left portal vein branches
Extrahepatic disease, other than regional lymph nodes that would be removed at time of surgery as part of a routine oncologic procedure for iCCA
Previous treatment with chemotherapy, intra-arterial or radiotherapy for iCCA is exclusionary, with the exception of adjuvant therapy with capecitabine which is allowed.
Contraindication to durvalumab, gemcitabine, or cisplatin
Active hepatitis B or C for which patients refuse treatment. Patients who are newly diagnosed with active disease as part of protocol screening and are agreeable to initiate on antiviral treatment are allowed to enroll.
Contraindication found during work-up angiography, including significant lung shunting (lung dose \>30 Gy for a single treatment or \>50 Gy cumulative), or non-manageable extrahepatic deposition of technetium Tc 99m macroaggregated albumin on scintigraphy performed after planning angiography
\> 75% hepatic tumor burden
Inability to protect non-target arteries to intestines or solid organs from radioembolization
Serum albumin \< 3 g/dL
Serum bilirubin \> 2 mg/dL, serum aspartate aminotransferase or alanine aminotransferase \> 5 times upper limit of normal
Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.
Life-threatening intercurrent illness
Anticipated poor compliance
Prisoners or subjects who are involuntarily incarcerated
Persons with decisional incapacity/cognitive impairment
Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator unsuitable for the study
Subject is enrolled in a separate interventional clinical trial

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 Fairfax?

Yes, this clinical trial (NCT05422690) has an active research site in Fairfax, VA 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.

Intrahepatic Cholangiocarcinoma Treatment Options in Fairfax, VA

If you're searching for intrahepatic cholangiocarcinoma treatment options in Fairfax, VA, this clinical trial (NCT05422690) 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 Fairfax research site is actively enrolling participants for this clinical trial. You'll receive care from experienced 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 intrahepatic cholangiocarcinoma clinical trials near you to find additional studies recruiting in your area.

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