A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma

Summary

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.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Gemcitabine

  See arm for details.

• Drug
  Oxaliplatin

  See arm for details.

• Drug
  Dexamethasone

  See arm for details.

• Drug
  Floxuridine (FUDR)

  See arm for details.

• Device
  Implanted Medical Device

  Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy

Locations (11)