Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery (NCT04891289)
A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: National Heart, Lung, and Blood Institute (NIH) (Data Collection Only) — Bethesda, Maryland
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- National Heart, Lung, and Blood Institute (NIH) (Data Collection Only) — Bethesda, Maryland
- Washington University (Data Collection Only) — St Louis, Missouri
- Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities — Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth - Limited Protocol Activities — Middletown, New Jersey
- Memorial Sloan Kettering Bergen - Limited Protocol Activities — Montvale, New Jersey
- Memorial Sloan Kettering Commack - Limited Protocol Activities — Commack, New York
- Memorial Sloan Kettering Westchester - Limited Protocol Activities — Harrison, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Memorial Sloan Kettering Nassau - Limited Protocol Activities — Uniondale, New York
- Duke University (Data Collection Only) — Durham, North Carolina
- Erasmus University (Data Collection Only) — Rotterdam,
📞 Contact the Study Coordinator
Phone: (646) 888-4189
Email: cerceka@mskcc.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Intrahepatic Cholangiocarcinoma
- Combination Therapy Using Durvalumab and Histotripsy for Treatment of Intrahepatic Cholangiocarcinoma — Madison, Wisconsin
- A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement — Birmingham, Alabama
- Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma — Baltimore, Maryland
- The Purpose of This Research Study is to See if Combining Gemcitabine, Cisplatin and Durvalumab Chemotherapy Treatments With a Direct Tumor Therapy Yittrium-90 (Y-90) Will Work Better Together to Shrink Tumors and Control Cancer — Fairfax, Virginia
- Liver Transplantation in Intrahepatic Cholangiocarcinoma — Newark, New Jersey
Explore by condition: All Intrahepatic Cholangiocarcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.