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New treatment option for Intrahepatic Cholangiocarcinoma
Official title Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery
ClinicalTrials.gov ID: NCT04891289
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, being studied as a potential treatment for intrahepatic cholangiocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- ECOG 0-1
- Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or...
- Clinical or radiographic evidence of metastatic disease confined to the liver. Note: presence of regional (porta hepatis) lymph node metastases will...
- Radiographically measurable disease. Measurable disease is defined as disease that can be assessed with 2-dimensional measurements on a...
You likely can't join if
- Presence of distant metastatic disease. Patients will undergo radiographic evaluation to exclude the possibility of distant metastatic disease. For...
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
- St Louis, Missouri, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
- Durham, North Carolina, United States
- Rotterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States; St Louis, Missouri, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.