Intrahepatic CholangiocarcinomaPhase 2NCT04891289
Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery
A Phase 2 study testing Gemcitabine, Oxaliplatin and Dexamethasone in people with Intrahepatic Cholangiocarcinoma, run by Memorial Sloan Kettering Cancer Center at 11 sites in 2 countries.
Trial summary
This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. 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?
- Gemcitabine, Oxaliplatin and Dexamethasone
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 7 May 2021to May 2027
- Phase
- Phase 2
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
- Age ≥18 years
- ECOG 0-1
- Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (IHC). Confirmation of the diagnosis at MSKCC or at the enrolling institution must be obtained prior to randomization.
- Clinical or radiographic evidence of metastatic disease confined to the liver. Note: presence of regional (porta hepatis) lymph node metastases will be allowed, provided they are amenable to resection. (Note: If peritoneal or other extrahepatic disease is found at time of pump placement, the pump will not be implanted. The patient will be removed from study, deemed nonevaluable and will not count toward the overall study accrual.)
- Radiographically measurable disease. Measurable disease is defined as disease that can be assessed with 2-dimensional measurements on a cross-sectional imaging. Minimum lesion size is 2 cm in greatest diameter as per RECIST criteria.
- Disease must be considered unresectable at the time of preoperative evaluation.*
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- Considered candidate for general anesthesia, abdominal exploration and hepatic artery pump placement.
- Patients with chronic hepatitis and/or cirrhosis are eligible, but must be Child-Pugh class A.
- WBC ≥ 2,000/mcL , ANC ≥ 1000/mcL
- Platelet count ≥ 75,000/mcL
- Creatinine ≤ 1.8 mg/dL
- Total bilirubin < 1.5 mg/dL
- Hgb > 7 g/dL The % involvement of the liver will be determined by radiologists after review of imaging
Who cannot join
- Presence of distant metastatic disease. Patients will undergo radiographic evaluation to exclude the possibility of distant metastatic disease. For patients who have undergone pre- or post-operative biopsies that definitively diagnose IHC, the diagnostic studies may be modified at the discretion of the MSKCC Principal Investigator. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.
- Patients previously treated with systemic chemotherapy for IHC will be non-eligible.
- Prior treatment with FUDR.
- Prior external beam radiation therapy to the liver.
- Prior ablative therapy to the liver.
- Diagnosis of sclerosing cholangitis.
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- Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis; surgically related ascites does not exclude the patient).
- Active infection within one week prior to HAI placement.
- Pregnant or lactating women.
- History of other malignancy within the past 3 years except with early stage/localized cancer that was surgically resected or radiation treatment that would yield the same result as surgery within the past 3 years.
- Life expectancy <12 weeks.
- Inability to comply with study and/or follow-up procedures.
- History of peripheral neuropathy. There is no exclusion of patients based on sex, ethnicity or race. For these reasons, the study results are expected to be generalizable to the Medicare beneficiary population.
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
William Jarnagin, MD contact
11 sites in 2 countries
United States10 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities
Basking Ridge, New Jersey, 07920
Andrea Cercek, MD, 646-888-4189
Andrea Cercek, MD
- Active, not recruiting
National Heart, Lung, and Blood Institute (NIH) (Data Collection Only)
Bethesda, Maryland, 20824
- Recruiting
Memorial Sloan Kettering Commack - Limited Protocol Activities
Commack, New York, 11725
Andrea Cercek, MD, 646-888-4189
Andera Cercek, MD
- Active, not recruiting
Duke University (Data Collection Only)
Durham, North Carolina, 27710
- Recruiting
Memorial Sloan Kettering Westchester - Limited Protocol Activities
Harrison, New York, 10604
Andrea Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Monmouth - Limited Protocol Activities
Middletown, New Jersey, 07748
Andrea Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Bergen - Limited Protocol Activities
Montvale, New Jersey, 07645
Andrea Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Andrew Cercek, MD, 646-888-4189
- Active, not recruiting
Washington University (Data Collection Only)
St Louis, Missouri, 63110
- Recruiting
Memorial Sloan Kettering Nassau - Limited Protocol Activities
Uniondale, New York, 11553
Andrea Cercek, MD, 646-888-4189
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University (Data Collection Only)
Rotterdam, 3015 GD
Bas Groot Koerkamp, MD, + 31 10 704 0 704
About this study
Official title: A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma
This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progression of disease. For the study treatment to be considered better than the standard treatment, the study treatment should increase the time until progression of disease by an average of 3 months, compared with the usual approach.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- Gemcitabine, Oxaliplatin, Dexamethasone, Floxuridine (FUDR), Implanted Medical Device
- Keywords
- Gemcitabine, Oxaliplatin, Floxuridine, Dexamethasone Pump, 20-348
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
See arm for details.
OxaliplatinDrug
See arm for details.
DexamethasoneDrug
See arm for details.
Floxuridine (FUDR)Drug
See arm for details.
Implanted Medical DeviceDevice
Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy
| Study group | Role | What they receive |
|---|---|---|
| HAI FUDR plus GemOx (Arm 1) | Experimental | Surgical HAI pump placement. 2. HAI FUDR [(0.12 mg/kg/day) x wt (kg) x (30ml) / pump flow rate ] and dexamethasone [1 mg/day * 30] / pump flow rate ] on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. 3. Gemcitabine (800 mg/m2 IV over 30 minutes) and oxaliplatin (85 mg/ m2 IV over 120 minutes on Days 1 and 15 of each cycle; however, for patients in Arm 1, initiation of systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first dose of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. Receives: Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Dexamethasone; Drug: Floxuridine (FUDR); Device: Implanted Medical Device |
| GemOx alone (Arm 2) | Active comparator | Gemcitabine (800 mg/m2 IV over 30 minutes) and oxaliplatin (85 mg/m2 IV over approximately 120 minutes) on Days 1 and 15 of each 28-day cycle.For patients in Arm 2, systemic therapy will be administered on Days 1 and Day 15 of each Cycle on a 28-day cycle basis, compromised of Gemcitabine and Oxaliplatin. If a patient randomized to Arm 2 has intrahepatic progression on any follow-up scan during study treatment, that patient will be eligible to crossover to Arm 1 and commence to pump placement surgery and HAI FUDR treatment. Patients with any extrahepatic progression will not be eligible to utilize the crossover arm. Arm 2 patients will have 28 days from date of the scan showing intrahepatic progression to proceed to the crossover arm. Receives: Drug: Gemcitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess progression-free survival (PFS)
will be done using RECIST (version 1.1).
Measured: 2 years
Secondary outcomes (1)
Overall survival (OS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start7 May 2021
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- This is a multi-center, prospective randomized controlled phase II study.
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Cercek, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891289
- Sponsor's protocol ID
- 20-348
- Status last verified
- Oct 2026
- First submitted
- 7 May 2021
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Publications
Blair AB, Alobuia WM, Palta M, Raman SS, Levine MH, Benson AB 3rd, D'Angelica MI, Cloyd JM. Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma. J Natl Compr Canc Netw. 2025 Aug 14;23(9):e257085. doi: 10.6004/jnccn.2025.7085.
PubMed 40812353