A Phase 2 interventional study of Floxuridine (FUDR) and dexamethasone in Intrahepatic Cholangiocarcinoma, Peripheral Cholangiocarcinoma and Cholangiolar Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 6 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment
The purpose of this study is to use both, liver pump treatment and systemic chemotherapy, to assess the effects this type of treatment has on the patient and the tumor. Liver pump treatment uses a metal pump that is surgically placed in the abdomen and gives chemotherapy directly to the liver. Systemic chemotherapy gives chemotherapy through a vein [intravenously (IV)] and treats the whole body. This type of treatment has been done before and had shown that people with both pump and systemic chemotherapy had improved results. The investigators hope that this combination of treatments improves the response to chemotherapy and reduces the spread of the disease.
Another purpose of this study is to learn the clinical importance of a specific type of MRI scan. The investigators would like to see if this type of MRI will help predict the response to the treatment and see if they could help the physician with their treatment plan. These scans will be done at specific time points.
The last purpose of this study is to learn more about how the tumor interacts with the chemotherapy. This will be done through a biopsy taken during surgery and blood draws at specific time points.
Permission from patients entering the study will be obtained to take normal and tumor liver biopsies at the time of surgery. These samples are voluntary and optional.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's enrollment of 56 is above the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day30} 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. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Drug: Floxuridine (FUDR) · Drug: dexamethasone · Drug: Gemcitabine · Drug: Oxaliplatin · Other: MRI · Other: Research blood draws
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/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. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Drug: Floxuridine (FUDR) · Drug: dexamethasone · Drug: Gemcitabine · Drug: Oxaliplatin · Other: MRI · Other: Research blood draws
All patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.
Drug: dexamethasone · Drug: Gemcitabine · Other: MRI · Other: Research blood draws
These are optional
Progression Free Survival for Cohort 1
Treatment evaluation will be done using RECIST (version 1.1). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: 6 months
Progression Free Survival for Cohort 2
Treatment evaluation will be done using RECIST (version 1.1). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: 3 months
Response for Cohort 3
Treatment evaluation will be done using RECIST (version 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: 6 months
Overall Survival
This study will investigate DCE-MRI as potential imaging biomarkers and will measure tumor perfusion parameters and diffusion coefficients before initiating treatment and on follow-up MRI scans during treatment..
Time frame: 1 year
Number of Participants Evaluated for Disease Progression After Initiation of HAI Placement
This study will investigate diffusion weighted imaging (DWI) as potential imaging biomarkers and will measure tumor perfusion parameters and diffusion coefficients before initiating treatment and on follow-up MRI scans during treatment.
Time frame: 1 year
| Milestone | No Prior Chemo or Responded/Stable With Prior Chemo | Patients Who Have Failed Systemic Therapy | Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy |
|---|---|---|---|
| Started | 42 | 5 | 9 |
| Completed | 38 | 5 | 8 |
| Not completed | 4 | 0 | 1 |
| Withdrew: Due to toxicity | 4 | 0 | 1 |
Treatment evaluation will be done using RECIST (version 1.1). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
| Participants | No Prior Chemo or Responded/Stable With Prior Chemo | Patients Who Have Failed Systemic Therapy | Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy |
|---|---|---|---|
| Participants With Progression Free Survival at 6 months | 38 | 0 | 0 |
| Participants Without Progression Free Survival at 6 months | 4 | 0 | 0 |
Treatment evaluation will be done using RECIST (version 1.1). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
| Participants | No Prior Chemo or Responded/Stable With Prior Chemo | Patients Who Have Failed Systemic Therapy | Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy |
|---|---|---|---|
| Withdrew Consent | 0 | 1 | 0 |
| Noncompliant | 0 | 1 | 0 |
| Progression of Disease after initiation of HAI Placement | 0 | 3 | 0 |
Treatment evaluation will be done using RECIST (version 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
| Participants | No Prior Chemo or Responded/Stable With Prior Chemo | Patients Who Have Failed Systemic Therapy | Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy |
|---|---|---|---|
| Partial Response | 0 | 0 | 1 |
| Stable Disease | 0 | 0 | 7 |
| Not evaluable | 0 | 0 | 1 |
This study will investigate DCE-MRI as potential imaging biomarkers and will measure tumor perfusion parameters and diffusion coefficients before initiating treatment and on follow-up MRI scans during treatment..
| percentage of participants | No Prior Chemo or Responded/Stable With Prior Chemo | Patients Who Have Failed Systemic Therapy | Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy |
|---|---|---|---|
| Overall Survival | 84.4 (68 to 93) | — | — |
This study will investigate diffusion weighted imaging (DWI) as potential imaging biomarkers and will measure tumor perfusion parameters and diffusion coefficients before initiating treatment and on follow-up MRI scans during treatment.
| Participants | No Prior Chemo or Responded/Stable With Prior Chemo | Patients Who Have Failed Systemic Therapy | Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy |
|---|---|---|---|
| Withdrew consent | — | 1 | — |
| Noncompliant | — | 1 | — |
| Progression of Disease after initiation of HAI Placement | — | 3 | — |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Prior Chemo or Responded/Stable With Prior Chemo | 25/42 (59.5%) | 4/42 (9.5%) | 42/42 (100%) |
| Patients Who Have Failed Systemic Therapy | 4/5 (80%) | 3/5 (60%) | 5/5 (100%) |
| Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy | 6/9 (66.7%) | 4/9 (44.4%) | 7/9 (77.8%) |
| Event | No Prior Chemo or Responded/Stable With Prior Chemo | Patients Who Have Failed Systemic Therapy | Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy |
|---|---|---|---|
| Abdominal PainGastrointestinal disorders | 0/42 | 2/5 | 1/9 |
| Death NOSGeneral disorders | 0/42 | 0/5 | 2/9 |
| ConfusionPsychiatric disorders | 0/42 | 1/5 | 0/9 |
| DiarrheaGastrointestinal disorders | 0/42 | 1/5 | 0/9 |
| EncephalopathyNervous system disorders | 0/42 | 1/5 | 0/9 |
| Hepatobiliary disorders - Other, specifyHepatobiliary disorders | 0/42 | 1/5 | 0/9 |
| NauseaGastrointestinal disorders | 0/42 | 1/5 | 0/9 |
| VomitingGastrointestinal disorders | 0/42 | 1/5 | 0/9 |
| AnemiaBlood and lymphatic system disorders | 0/42 | 0/5 | 1/9 |
| Cardiac arrestCardiac disorders | 0/42 | 0/5 | 1/9 |
| Event | No Prior Chemo or Responded/Stable With Prior Chemo | Patients Who Have Failed Systemic Therapy | Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy |
|---|---|---|---|
| Elevated ALTInvestigations | 42/42 | 2/5 | 2/9 |
| Elevated ASTInvestigations | 34/42 | 1/5 | 2/9 |
| AnemiaBlood and lymphatic system disorders | 16/42 | 3/5 | 7/9 |
| HyponatremiaMetabolism and nutrition disorders | 8/42 | 1/5 | 5/9 |
| Elevated BilirubinInvestigations | 18/42 | 0/5 | 2/9 |
| Decreased Lymphocyte CountInvestigations | 5/42 | 2/5 | 3/9 |
| Neutrophil count decreasedInvestigations | 0/42 | 2/5 | 1/9 |
| White blood cell decreasedInvestigations | 0/42 | 2/5 | 1/9 |
| Elevated Alk PhosInvestigations | 13/42 | 1/5 | 2/9 |
| HypophosphatemiaMetabolism and nutrition disorders | 13/42 | 1/5 | 0/9 |
| Age, Continuous(years) | No Prior Chemo or Responded/Stable With Prior Chemo | Patients Who Have Failed Systemic Therapy | Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy | Total |
|---|---|---|---|---|
| Mean | 60 (38 to 80) | 69 (31 to 76) | 64 (5 to 76) | 63 (5 to 80) |
| Sex: Female, Male(Participants) | No Prior Chemo or Responded/Stable With Prior Chemo | Patients Who Have Failed Systemic Therapy | Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy | Total |
|---|---|---|---|---|
| Female | 28 | 3 | 7 | 38 |
| Male | 14 | 2 | 2 | 18 |
| Ethnicity (NIH/OMB)(Participants) | No Prior Chemo or Responded/Stable With Prior Chemo | Patients Who Have Failed Systemic Therapy | Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 42 | 5 | 9 | 56 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | No Prior Chemo or Responded/Stable With Prior Chemo | Patients Who Have Failed Systemic Therapy | Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 | 2 |
| White | 40 | 5 | 8 | 53 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | No Prior Chemo or Responded/Stable With Prior Chemo | Patients Who Have Failed Systemic Therapy | Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy | Total |
|---|---|---|---|---|
| United States | 42 | 5 | 9 | 56 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Memorial Sloan Kettering Cancer Center