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Chemotherapy +/− FUDR/Dexamethasone Pump for Bile Duct Cancer
Study Summary
This trial will compare a new combination therapy to standard chemotherapy in people with inoperable cholangiocarcinoma. The goal is to see if the new therapy extends life by at least 3 months on average.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had cancer before, but it was early stage and treated with surgery or radiation within the last 3 years.I have not had an infection in the week before my planned procedure.My cancer can be measured on scans and is at least 2 cm big.My condition cannot be treated with surgery.I am 18 years old or older.My cancer is a specific type called intrahepatic cholangiocarcinoma, confirmed by a test.I have chronic hepatitis or cirrhosis but my liver is still functioning well.I have not had chemotherapy for my cancer.I have been treated with FUDR before.My hemoglobin level is above 7 g/dL and a radiologist will check my liver.My cancer has spread only to my liver, and possibly nearby lymph nodes that can be removed.I have a history of nerve damage in my hands or feet.I have had radiation therapy targeted at my liver before.I have been diagnosed with sclerosing cholangitis.I am fully active or can carry out light work.My cancer has spread to distant parts of my body but not beyond treatment.I have had treatment to destroy liver tumors.I have signs of high blood pressure in the liver veins.Your doctor believes you have less than 12 weeks to live.I am fit for surgery that involves exploring the abdomen and placing a pump in the liver artery.
- Group 1: GemOx alone (Arm 2)
- Group 2: HAI FUDR plus GemOx (Arm 1)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the extent of Gemcitabine's patient risks?
"There is some data supporting Gemcitabine's safety, but since this is only a Phase 2 trial, there is no information yet on whether or not it is effective. Therefore, it received a score of 2."
Is this research project actively looking for new participants?
"That is correct. The listings on clinicaltrials.gov show that this study is still open and recruiting patients. This trial was first posted on May 7th, 2021, with the most recent update being September 27th, 2022. They are looking for 164 individuals to participate at 9 different sites."
How many people are the investigators enrolling in this research project?
"In order to obtain the desired data, 164 individuals that fit the bill are required to partake in this experiment. These participants must visit one of the many specified locations which include Memorial Sloan Kettering Cancer Center in New york and North carolina, or Memorial Sloan Kettering Commack in New jersey."
What is Gemcitabine commonly prescribed for?
"Gemcitabine is commonly used to treat ophthalmia, sympathetic. It can also be used effectively against branch retinal vein occlusion, small cell lung cancer (sclc), and macular edema."
How many hospitals are participating in this experiment?
"Memorial Sloan Kettering Cancer Center is the primary location for this study, however it is also taking place in New jersey, North carolina, Missouri and 9 other states."
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