Gemcitabine and Oxaliplatin for Intrahepatic Cholangiocarcinoma
Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
164 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
This trial is looking for people with a type of cancer called intrahepatic cholangiocarcinoma that cannot be treated with surgery. Participants will receive a specific combination of chemotherapy and possibly a special pump to help treat their cancer.
Are You a Good Fit for This Trial?
Rules you outSclerosing cholangitisActive infectionOther malignancy within the past 3 yearsPortal hypertension
You may be able to join if
I am at least 18 years old.
I have been diagnosed with intrahepatic cholangiocarcinoma.
I have cancer that is only in my liver.
I have measurable cancer that can be seen on scans.
My cancer cannot be removed with surgery right now.
I can be put under general anesthesia.
I have certain blood test results that are within the required range.
I have chronic hepatitis or cirrhosis, but it is classified as Child-Pugh class A.
You may not be able to join if
I have cancer that has spread to areas outside my liver.
I have had chemotherapy for intrahepatic cholangiocarcinoma before.
I have received treatment with a specific drug called FUDR.
I have had radiation therapy or any type of ablative therapy to my liver.
I have been diagnosed with sclerosing cholangitis.
I have active infections within a week before starting treatment.
I am pregnant or breastfeeding.
I have any serious health issues that limit my life expectancy.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 o…
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 Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 m…
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
* 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.
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