Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery
A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma
1 other identifier
interventional
164
2 countries
11
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2021
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2021
CompletedStudy Start
First participant enrolled
May 7, 2021
CompletedFirst Posted
Study publicly available on registry
May 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
April 22, 2026
April 1, 2026
6 years
May 7, 2021
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
assess progression-free survival (PFS)
will be done using RECIST (version 1.1).
2 years
Secondary Outcomes (1)
Overall survival (OS)
2 years
Study Arms (2)
HAI FUDR plus GemOx (Arm 1)
EXPERIMENTALSurgical 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.
GemOx alone (Arm 2)
ACTIVE COMPARATORGemcitabine (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.
Interventions
Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy
Eligibility Criteria
You may qualify if:
- 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.\*
- 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
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
National Heart, Lung, and Blood Institute (NIH) (Data Collection Only)
Bethesda, Maryland, 20824, United States
Washington University (Data Collection Only)
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth - Limited Protocol Activities
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen - Limited Protocol Activities
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack - Limited Protocol Activities
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester - Limited Protocol Activities
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau - Limited Protocol Activities
Uniondale, New York, 11553, United States
Duke University (Data Collection Only)
Durham, North Carolina, 27710, United States
Erasmus University (Data Collection Only)
Rotterdam, 3015 GD, Netherlands
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Cercek, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2021
First Posted
May 18, 2021
Study Start
May 7, 2021
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.