OncoMatch/Clinical Trials/NCT04891289
Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery
Is NCT04891289 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for intrahepatic cholangiocarcinoma.
Treatment: Gemcitabine · Oxaliplatin · Dexamethasone · Floxuridine (FUDR) · Implanted Medical Device — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
Patients previously treated with systemic chemotherapy for IHC will be non-eligible.
Cannot have received: (floxuridine)
Prior treatment with FUDR.
Cannot have received: external beam radiation therapy
Prior external beam radiation therapy to the liver.
Cannot have received: ablative therapy
Prior ablative therapy to the liver.
Lab requirements
Blood counts
WBC ≥ 2,000/mcL, ANC ≥ 1000/mcL, Platelet count ≥ 75,000/mcL, Hgb > 7 g/dL
Kidney function
Creatinine ≤ 1.8 mg/dL
Liver function
Total bilirubin < 1.5 mg/dL; Child-Pugh class A if cirrhosis
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. Patients with chronic hepatitis and/or cirrhosis are eligible, but must be Child-Pugh class A.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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