Intrahepatic CholangiocarcinomaPhase 2NCT05422690
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
A Phase 2 study testing Induction Chemotherapy Triplet Therapy, Concurrent Y-90 treatment and Consolidation Doublet Therapy: in people with Intrahepatic Cholangiocarcinoma, run by Inova Health Care Services at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- Induction Chemotherapy Triplet Therapy, Concurrent Y-90 treatment and Consolidation Doublet Therapy:
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2024to 30 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Show all 34Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elahe Mollapour contact
United States1 site, 1 recruiting
- Recruiting
Keary Janet
Fairfax, Virginia, 22031
Keary Janet, BS, 571-472-0224, keary.janet@inova.org
Elahe Mollapour, elahe.mollapour@inova.org
About this study
Official title: A Phase II Single-center, Open-label, Single Arm Study of Induction Gemcitabine, Cisplatin and Durvalumab Followed by Gemcitabine, Cisplatin and Yttrium-90 (Y-90) Radioembolization for the Treatment of Locally Advanced Unresectable Intrahepatic Cholangiocarcinoma
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.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- Induction Chemotherapy Triplet Therapy, Concurrent Y-90 treatment, Consolidation Doublet Therapy:
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction Chemotherapy Triplet TherapyDrug
Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 infused on both day 1 and day 8 of a 21-day cycle. Durvalumab 1500 mg will be given on day 1 of each cycle.
Concurrent Y-90 treatmentRadiation
Patients will undergo a Y-90 treatment planning consultation by the treating interventional radiologist during cycle 1. One or two cycles (depending on tumor size) of cisplatin, 25 mg/m2 and gemcitabine 300 mg/m2 given on day 1 and day 8 in combination with Yttrium-90 (Y-90) microspheres which will be given on day 3-7 or day 10-21 at the discretion of the interventional radiologist, separated in time by at least 2 days from a chemo infusion during that cycle
Consolidation Doublet Therapy:Drug
Gemcitabine 1000 mg/m2 and Cisplatin 25 mg/m2 given on days 1 and 8 of a 21-day cycle with durvalumab 1500 mg given on day 1 of each cycle for 3-5 additional cycles. For the cycle directly after Y-90, gemcitabine will be kept at a dose of 300 mg/m2 to minimize risk of toxicity.
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine, cisplatin and Durvalumab chemotherapy with Yittrium-90 | Experimental | single arm - Induction Gemcitabine, Cisplatin and Durvalumab Triplet Chemotherapy followed by Gemcitabine, Cisplatin in combination with yttrium-90 (Y-90) Radioembolization Receives: Drug: Induction Chemotherapy Triplet Therapy; Radiation: Concurrent Y-90 treatment; Drug: Consolidation Doublet Therapy: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the objective response rate (ORR) at 6 months in patients with locally advanced, unresectable intrahepatic cholangiocarcinoma (iCCA)
Best response in terms of tumor shrinkage (by RECIST 1.1 criteria including complete + partial responses) obtained during protocol therapy.
Measured: 6 months
Secondary outcomes (8)
Assessing Progression Free Survival (PFS)
time from treatment initiation to disease progression, death or last patient contact
Measured: 48 months
Hepatic Progression-Free Survival (HPFS)
time from treatment initiation to hepatic disease progression, death or last patient contact
Measured: 48 months
Overall Survival (OS)
Time from treatment initiation to death due to any cause or last patient contact
Measured: 48 months
Disease Control Rate (DCR)
Complete Response + Partial Response + Stable Disease (by RECIST 1.1 and mRECIST criteria) obtained during protocol therapy.
Measured: 48 months
R0 resection rate
Rate of patients that achieve an R0 resection at 6 months.
Measured: 6 months
treatment related impact on quality of life
Self-assessed metric of treatment-related impact on Quality of Life (QOL) as measured by the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) questionnaire with measures of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Hepatobiliary Cancer Subscale using a 5 point scale ((0) Not at all (1) A little bit; (2) Somewhat; (3) Quite a bit; (4) Very much). Better performance status, i.e. higher score, is associated with a higher quality of life.
Measured: 48 months
safety and toxicity rate
Development of Treatment Toxicities (grade 3 non-hematologic toxicities persisting beyond 2 weeks despite best supportive care, any grade 3 hematologic toxicities, or any toxicity grade 4 or higher) assessed as per NCI's CTCAE v5.0 criteria.
Measured: 48 months
rate of downstaging to surgery
Rate of downstaging to surgery that occurs during protocol therapy at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start12 Jun 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatments are repeated every 21 days. Chemotherapy will be administered on days 1 and 8 of the 21 day cycle. For the first two cycles, treatment will consist of three drugs, gemcitabine, cisplatin and Durvalumab. After these two cycles, the Durvalumab will be removed from the treatment plan and participants will continue on trial with gemcitabine and cisplatin alone for 6 additional cycles (8 total cycles, or 6 months total of treatment). During the 3rd and possibly the 4th cycle, these drugs will be given at a reduced dose as y-90 treatment to the tumors in your liver will also be given. The interventional team will administer y-90 during these cycles as either one dose during cycle 3, or two doses, one during cycle 3 and one during cycle 4 if there is too much cancer to treat all at once. The remaining cycles of treatment will be with gemcitabine and cisplatin by themselves.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur A. Winer, MD, Principal investigator, Inova Schar Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422690
- Sponsor's protocol ID
- U22-02-4670
- Status last verified
- Jul 2026
- First submitted
- 27 May 2022
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Saha SK, Zhu AX, Fuchs CS, Brooks GA. Forty-Year Trends in Cholangiocarcinoma Incidence in the U.S.: Intrahepatic Disease on the Rise. Oncologist. 2016 May;21(5):594-9. doi: 10.1634/theoncologist.2015-0446. Epub 2016 Mar 21.
PubMed 27000463Ribero D, Pinna AD, Guglielmi A, Ponti A, Nuzzo G, Giulini SM, Aldrighetti L, Calise F, Gerunda GE, Tomatis M, Amisano M, Berloco P, Torzilli G, Capussotti L; Italian Intrahepatic Cholangiocarcinoma Study Group. Surgical Approach for Long-term Survival of Patients With Intrahepatic Cholangiocarcinoma: A Multi-institutional Analysis of 434 Patients. Arch Surg. 2012 Dec;147(12):1107-13. doi: 10.1001/archsurg.2012.1962.
PubMed 22910846Si A, Li J, Xiang H, Zhang S, Bai S, Yang P, Zhang X, Xia Y, Wang K, Yan Z, Lau WY, Shi L, Shen F. Actual over 10-year survival after liver resection for patients with intrahepatic cholangiocarcinoma. Oncotarget. 2017 Jul 4;8(27):44521-44532. doi: 10.18632/oncotarget.17815.
PubMed 28562348Tarchi P, Tabrizian P, Prigoff J, Schwartz M. Outcomes of resection for solitary </=5 cm intrahepatic cholangiocarcinoma. Surgery. 2018 Apr;163(4):698-702. doi: 10.1016/j.surg.2017.09.058. Epub 2017 Dec 23.
PubMed 29277385Yeh CN, Hsieh FJ, Chiang KC, Chen JS, Yeh TS, Jan YY, Chen MF. Clinical effect of a positive surgical margin after hepatectomy on survival of patients with intrahepatic cholangiocarcinoma. Drug Des Devel Ther. 2014 Dec 17;9:163-74. doi: 10.2147/DDDT.S74940. eCollection 2015.
PubMed 25552905Lang H, Sotiropoulos GC, Fruhauf NR, Domland M, Paul A, Kind EM, Malago M, Broelsch CE. Extended hepatectomy for intrahepatic cholangiocellular carcinoma (ICC): when is it worthwhile? Single center experience with 27 resections in 50 patients over a 5-year period. Ann Surg. 2005 Jan;241(1):134-43. doi: 10.1097/01.sla.0000149426.08580.a1.
PubMed 15622001Mazzaferro V, Gorgen A, Roayaie S, Droz Dit Busset M, Sapisochin G. Liver resection and transplantation for intrahepatic cholangiocarcinoma. J Hepatol. 2020 Feb;72(2):364-377. doi: 10.1016/j.jhep.2019.11.020.
PubMed 31954498De Martin E, Rayar M, Golse N, Dupeux M, Gelli M, Gnemmi V, Allard MA, Cherqui D, Sa Cunha A, Adam R, Coilly A, Antonini TM, Guettier C, Samuel D, Boudjema K, Boleslawski E, Vibert E. Analysis of Liver Resection Versus Liver Transplantation on Outcome of Small Intrahepatic Cholangiocarcinoma and Combined Hepatocellular-Cholangiocarcinoma in the Setting of Cirrhosis. Liver Transpl. 2020 Jun;26(6):785-798. doi: 10.1002/lt.25737.
PubMed 32090444Ilyas SI, Khan SA, Hallemeier CL, Kelley RK, Gores GJ. Cholangiocarcinoma - evolving concepts and therapeutic strategies. Nat Rev Clin Oncol. 2018 Feb;15(2):95-111. doi: 10.1038/nrclinonc.2017.157. Epub 2017 Oct 10.
PubMed 28994423Akateh C, Ejaz AM, Pawlik TM, Cloyd JM. Neoadjuvant treatment strategies for intrahepatic cholangiocarcinoma. World J Hepatol. 2020 Oct 27;12(10):693-708. doi: 10.4254/wjh.v12.i10.693.
PubMed 33200010Labib PL, Davidson BR, Sharma RA, Pereira SP. Locoregional therapies in cholangiocarcinoma. Hepat Oncol. 2017 Oct;4(4):99-109. doi: 10.2217/hep-2017-0014. Epub 2017 Nov 17.
PubMed 29367874Hyder O, Marsh JW, Salem R, Petre EN, Kalva S, Liapi E, Cosgrove D, Neal D, Kamel I, Zhu AX, Sofocleous CT, Geschwind JF, Pawlik TM. Intra-arterial therapy for advanced intrahepatic cholangiocarcinoma: a multi-institutional analysis. Ann Surg Oncol. 2013 Nov;20(12):3779-86. doi: 10.1245/s10434-013-3127-y. Epub 2013 Jul 12.
PubMed 23846786Kuhlmann JB, Euringer W, Spangenberg HC, Breidert M, Blum HE, Harder J, Fischer R. Treatment of unresectable cholangiocarcinoma: conventional transarterial chemoembolization compared with drug eluting bead-transarterial chemoembolization and systemic chemotherapy. Eur J Gastroenterol Hepatol. 2012 Apr;24(4):437-43. doi: 10.1097/MEG.0b013e3283502241.
PubMed 22261548Sommer CM, Kauczor HU, Pereira PL. Locoregional Therapies of Cholangiocarcinoma. Visc Med. 2016 Dec;32(6):414-420. doi: 10.1159/000453010. Epub 2016 Dec 5.
PubMed 28229076
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single-center, Open-label, Single Arm Study of Induction Gemcitabine, Cisplatin and Durvalumab Followed by Gemcitabine, Cisplatin and Yttrium-90 (Y-90) Radioembolization for the Treatment of Locally Advanced Unresectable Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT05422690
- Acronym / sponsor ID
- U22-02-4670
- Conditions
- Intrahepatic Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatments are repeated every 21 days. Chemotherapy will be administered on days 1 and 8 of the 21 day cycle. For the first two cycles, treatment will consist of three drugs, gemcitabine, cisplatin and Durvalumab. After these two cycles, the Durvalumab will be removed from the treatment plan and participants will continue on trial with gemcitabine and cisplatin alone for 6 additional cycles (8 total cycles, or 6 months total of treatment). During the 3rd and possibly the 4th cycle, these drugs will be given at a reduced dose as y-90 treatment to the tumors in your liver will also be given. The interventional team will administer y-90 during these cycles as either one dose during cycle 3, or two doses, one during cycle 3 and one during cycle 4 if there is too much cancer to treat all at once. The remaining cycles of treatment will be with gemcitabine and cisplatin by themselves.
| Arm | Type | Receives |
|---|---|---|
| gemcitabine, cisplatin and Durvalumab chemotherapy with Yittrium-90 | Experimental | Drug: Induction Chemotherapy Triplet Therapy, Radiation: Concurrent Y-90 treatment, Drug: Consolidation Doublet Therapy:single arm - Induction Gemcitabine, Cisplatin and Durvalumab Triplet Chemotherapy followed by Gemcitabine, Cisplatin in combination with yttrium-90 (Y-90) Radioembolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (34 listed)
- 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:
- Current or recent use of immunosuppressive medication within 14 days before durvalumab initiation except if:
- Child-Pugh B7 or greater cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induction Chemotherapy Triplet TherapyGemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 infused on both day 1 and day 8 of a 21-day cycle. Durvalumab 1500 mg will be given on day 1 of each cycle. | Drug | gemcitabine, cisplatin and Durvalumab chemotherapy with Yittrium-90 |
| Concurrent Y-90 treatmentPatients will undergo a Y-90 treatment planning consultation by the treating interventional radiologist during cycle 1. One or two cycles (depending on tumor size) of cisplatin, 25 mg/m2 and gemcitabine 300 mg/m2 given on day 1 and day 8 in combination with Yttrium-90 (Y-90) microspheres which will be given on day 3-7 or day 10-21 at the discretion of the interventional radiologist, separated in time by at least 2 days from a chemo infusion during that cycle | Radiation | gemcitabine, cisplatin and Durvalumab chemotherapy with Yittrium-90 |
| Consolidation Doublet Therapy:Gemcitabine 1000 mg/m2 and Cisplatin 25 mg/m2 given on days 1 and 8 of a 21-day cycle with durvalumab 1500 mg given on day 1 of each cycle for 3-5 additional cycles. For the cycle directly after Y-90, gemcitabine will be kept at a dose of 300 mg/m2 to minimize risk of toxicity. | Drug | gemcitabine, cisplatin and Durvalumab chemotherapy with Yittrium-90 |
Primary outcome
Assessing the objective response rate (ORR) at 6 months in patients with locally advanced, unresectable intrahepatic cholangiocarcinoma (iCCA)
Time frame: 6 months
Best response in terms of tumor shrinkage (by RECIST 1.1 criteria including complete + partial responses) obtained during protocol therapy.
8 secondary outcomes
Assessing Progression Free Survival (PFS)
Time frame: 48 months
Hepatic Progression-Free Survival (HPFS)
Time frame: 48 months
Overall Survival (OS)
Time frame: 48 months
Disease Control Rate (DCR)
Time frame: 48 months
R0 resection rate
Time frame: 6 months
treatment related impact on quality of life
Time frame: 48 months
safety and toxicity rate
Time frame: 48 months
rate of downstaging to surgery
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 27000463Saha SK, Zhu AX, Fuchs CS, Brooks GA. Forty-Year Trends in Cholangiocarcinoma Incidence in the U.S.: Intrahepatic Disease on the Rise. Oncologist. 2016 May;21(5):594-9. doi: 10.1634/theoncologist.2015-0446. Epub 2016 Mar 21.
- Background: PubMed 22910846Ribero D, Pinna AD, Guglielmi A, Ponti A, Nuzzo G, Giulini SM, Aldrighetti L, Calise F, Gerunda GE, Tomatis M, Amisano M, Berloco P, Torzilli G, Capussotti L; Italian Intrahepatic Cholangiocarcinoma Study Group. Surgical Approach for Long-term Survival of Patients With Intrahepatic Cholangiocarcinoma: A Multi-institutional Analysis of 434 Patients. Arch Surg. 2012 Dec;147(12):1107-13. doi: 10.1001/archsurg.2012.1962.
- Background: PubMed 28562348Si A, Li J, Xiang H, Zhang S, Bai S, Yang P, Zhang X, Xia Y, Wang K, Yan Z, Lau WY, Shi L, Shen F. Actual over 10-year survival after liver resection for patients with intrahepatic cholangiocarcinoma. Oncotarget. 2017 Jul 4;8(27):44521-44532. doi: 10.18632/oncotarget.17815.
- Background: PubMed 29277385Tarchi P, Tabrizian P, Prigoff J, Schwartz M. Outcomes of resection for solitary </=5 cm intrahepatic cholangiocarcinoma. Surgery. 2018 Apr;163(4):698-702. doi: 10.1016/j.surg.2017.09.058. Epub 2017 Dec 23.
- Background: PubMed 25552905Yeh CN, Hsieh FJ, Chiang KC, Chen JS, Yeh TS, Jan YY, Chen MF. Clinical effect of a positive surgical margin after hepatectomy on survival of patients with intrahepatic cholangiocarcinoma. Drug Des Devel Ther. 2014 Dec 17;9:163-74. doi: 10.2147/DDDT.S74940. eCollection 2015.
- Background: PubMed 15622001Lang H, Sotiropoulos GC, Fruhauf NR, Domland M, Paul A, Kind EM, Malago M, Broelsch CE. Extended hepatectomy for intrahepatic cholangiocellular carcinoma (ICC): when is it worthwhile? Single center experience with 27 resections in 50 patients over a 5-year period. Ann Surg. 2005 Jan;241(1):134-43. doi: 10.1097/01.sla.0000149426.08580.a1.
- Background: PubMed 31954498Mazzaferro V, Gorgen A, Roayaie S, Droz Dit Busset M, Sapisochin G. Liver resection and transplantation for intrahepatic cholangiocarcinoma. J Hepatol. 2020 Feb;72(2):364-377. doi: 10.1016/j.jhep.2019.11.020.
- Background: PubMed 32090444De Martin E, Rayar M, Golse N, Dupeux M, Gelli M, Gnemmi V, Allard MA, Cherqui D, Sa Cunha A, Adam R, Coilly A, Antonini TM, Guettier C, Samuel D, Boudjema K, Boleslawski E, Vibert E. Analysis of Liver Resection Versus Liver Transplantation on Outcome of Small Intrahepatic Cholangiocarcinoma and Combined Hepatocellular-Cholangiocarcinoma in the Setting of Cirrhosis. Liver Transpl. 2020 Jun;26(6):785-798. doi: 10.1002/lt.25737.
- Results publication: PubMed 28994423Ilyas SI, Khan SA, Hallemeier CL, Kelley RK, Gores GJ. Cholangiocarcinoma - evolving concepts and therapeutic strategies. Nat Rev Clin Oncol. 2018 Feb;15(2):95-111. doi: 10.1038/nrclinonc.2017.157. Epub 2017 Oct 10.
- Results publication: PubMed 33200010Akateh C, Ejaz AM, Pawlik TM, Cloyd JM. Neoadjuvant treatment strategies for intrahepatic cholangiocarcinoma. World J Hepatol. 2020 Oct 27;12(10):693-708. doi: 10.4254/wjh.v12.i10.693.
- Results publication: PubMed 29367874Labib PL, Davidson BR, Sharma RA, Pereira SP. Locoregional therapies in cholangiocarcinoma. Hepat Oncol. 2017 Oct;4(4):99-109. doi: 10.2217/hep-2017-0014. Epub 2017 Nov 17.
- Individual participant dataSharing planned: No
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Liver Cancer, Intrahepatic Cholangiocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elahe Mollapour contact
Arthur A. Winer, MD principal investigator
Inova Schar Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Induction Chemotherapy Triplet Therapy, Concurrent Y-90 treatment and Consolidation Doublet Therapy: in people with Intrahepatic Cholangiocarcinoma, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keary Janet, BS (571-472-0024, keary.janet@inova.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the objective response rate (ORR) at 6 months in patients with locally advanced, unresectable intrahepatic cholangiocarcinoma (iCCA) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05422690, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.