Study of Gemcitabine, Cisplatin, Durvalumab, and Y-90 for Intrahepatic Cholangiocarcinoma
This study is looking at whether combining chemotherapy drugs (gemcitabine, cisplatin, and durvalumab) with a targeted radiation treatment called Yttrium-90 (Y-90) can better shrink tumors and control cancer. This research is for people with intrahepatic cholangiocarcinoma (a type of liver cancer) that has not been treated before, or if treated, has been at least 6 months ago. The study aims to see how many participants' tumors shrink after 6 months of treatment. There are plans for 16 people to join this study, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 16 participants. It combines different drug therapies with radiation.
- What's involved
- You would receive induction chemotherapy, followed by Y-90 treatment and concurrent chemotherapy, and then consolidation chemotherapy. You would also have a Y-90 treatment planning consultation during the first cycle.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal is to assess tumor response at 6 months.
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NCT05422690
The Purpose of This Research Study is to See if Combining Gemcitabine, Cisplatin and Durvalumab Chemotherapy Treatments With a Direct Tumor Therapy Yittrium-90 (Y-90) Will Work Better Together to Shrink Tumors and Control Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentInova Health Care ServicesInvestigator-initiated
~16 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Induction Chemotherapy Triplet TherapyConcurrent Y-90 treatmentConsolidation Doublet Therapy:
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessing the objective response rate (ORR) at 6 months in patients with locally advanced, unresectable intrahepatic cholangiocarcinoma (iCCA)
Measured over 6 months
Conditions
NCT05422690
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.
Keary Janet
Fairfax, Virginiastudy 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
- Arthur A. Winer, MD · PRINCIPAL_INVESTIGATOR · Inova Schar Cancer Institute
Who to contact
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Assessing the objective response rate (ORR) at 6 months in patients with locally advanced, unresectable intrahepatic cholangiocarcinoma (iCCA)6 months
Best response in terms of tumor shrinkage (by RECIST 1.1 criteria including complete + partial responses) obtained during protocol therapy.